Recommended for Practice

Psychoeducation/Psychoeducational Interventions

for Anxiety

Psychoeducation or psychoeducational interventions encompass a broad range of activities that combine education and other activities such as counseling and supportive interventions. Psychoeducational interventions may be delivered individually or in groups, and may be tailored or standardized. This type of intervention generally includes providing patients with information about treatments, symptoms, resources and services, training to provide care and respond to disease-related problems, and problem-solving strategies for coping with cancer. Interventions may include use of booklets, videos, audiotapes, and computers, and formats may be interactive between healthcare professionals and patients and caregivers, self-directed via use of CDs and other materials, online, or delivered telephonically. Studies using psychoeducational interventions tend to vary substantially in specific content, format, frequency, and timing of the interventions. For this reason, there is limited ability to currently examine the relative effectiveness of different formats and delivery methods. Highly specific content approaches, such as mindfulness-based stress reduction and cognitive behavioral approaches, are identified in these resources as separate interventions, rather than incorporated into overall psychoeducation.

 

Systematic Review/Meta-Analysis

Bennett, S., Pigott, A., Beller, E.M., Haines, T., Meredith, P., & Delaney, C. (2016). Educational interventions for the management of cancer-related fatigue in adults. Cochrane Database of Systematic Reviews, 11, CD008144. 

Purpose

STUDY PURPOSE: To evaluate the effectiveness of educational interventions for managing fatigue in adults with cancer

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: CENTRAL, MEDLINE, ENBASE, CINAHL, ERIC, PEDro, PsycINFO, OT seeker, clinicaltrials.gov, and Australian New Zealand Clinical Trials Registry
 
INCLUSION CRITERIA: Randomized, controlled trials and adults with cancer. At least one study group received an educational intervention aimed at fatigue management.
 
EXCLUSION CRITERIA: Not specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 2,489
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane Risk of Bias tool. All the studies had lack of blinding for outcome assessment, which was not included in the final determination of study quality. All studies had high or unclear risk of bias related to sample size. The GRADE approach was used for study quality.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 14 studies  
  • TOTAL PATIENTS INCLUDED IN REVIEW = 2,213
  • SAMPLE RANGE ACROSS STUDIES: 30–396
  • KEY SAMPLE CHARACTERISTICS: Multiple different types of cancer at various phases of care. Most had mild to moderate fatigue at baseline.

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

  • For general fatigue: SMD = –0.27 (95% confidence interval [CI] [–0.51, –0.04]), showing a positive effect of education. These studies were of low quality.
  • For fatigue intensity: SMD = –0.28 (95% CI [–0.51, –0.04]) effect of education. These studies were of moderate quality.
  • For fatigue interference: SMD = –0.35 (95% CI [–0.54, –0.16]), showing benefit of education. Studies were of moderate quality.
  • For anxiety (three studies): SMD = –1.37 (95% [CI –2.76, –0.18]). Studies were of low quality.
  • For depression (four studies of very low quality), no impact on depression was found.
  • Insufficient evidence existed to analyze the results according to stage of disease, phase of care, and method of education delivery. Education was delivered individually, face-to-face, in group settings, or with self-use of video or print material. Most interventions included counseling and patient training components.

Conclusions

Educational interventions appear to play some role in reducing overall fatigue, fatigue intensity, and fatigue interference, and might provide some benefit for anxiety. No effect on depression was found in this study, but baseline levels of depression were not generally clinically relevant.

Limitations

  • High heterogeneity

Nursing Implications

The incorporation of educational interventions as part of care to manage fatigue is reasonable but may not be sufficient to have a clinically meaningful impact.

Print

Chien, C.H., Liu, K.L., Chien, H.T., & Liu, H.E. (2013). The effects of psychosocial strategies on anxiety and depression of patients diagnosed with prostate cancer: A systematic review. International Journal of Nursing Studies.

Purpose

To evaluate, by means of meta-analysis and systematic review, evidence regarding the effectiveness of psychosocial interventions for anxiety and depression in patients with prostate cancer

Search Strategy

Databases searched were PubMed, CINAHL, PsycINFO, Cochrane Collaboration, and two Chinese databases.

A study was included in the review if it

  • Was a randomized controlled trial
  • Reported on patients with prostate cancer at any disease stage
  • Compared psychosocial strategies to usual or standard care
  • Measured anxiety and depression.

A study was excluded if it focused on disease other than prostate cancer and lacked intergroup comparison.

Literature Evaluated

  • A total of 8,144 references were retrieved.
  • Researchers evaluated the quality of studies by using the Jadad scale.

Sample Characteristics

  • After evaluation, 14 studies, relating to a total of 1,484 patients, were included in the review.
  • Sample range across studies/total patients included in the review was 36–400 patients.
  • Patient age range was 60–76 years.
  • In all but four studies, patients were newly diagnosed.

Phase of Care and Clinical Applications

Patients were undergoing multiple phases of care.

Results

  • Interventions included education (n = 8), cognitive behavioral strategies (n = 6), counseling or psychotherapy (n = 1), and social support (n = 1).
  • Analysis showed that psychosocial strategies did not have a significant immediate effect on reducing anxiety. After three months, there was a significant overall effect on reducing anxiety from two studies included in meta-analysis (SMD = –1.13, 95% CI –1.64, –0.63, p < 0.0001).
  • Eight studies resulted in an overall positive effect on depression in the short term (SMD = –0.43, 95% CI –0.68, –0.18, p < 0.001). Three studies resulted in no significant effect at one-month follow-up. Across two studies, analysis showed a positive effect at three months (SMD = –0.78, 95% CI –1.54, –0.02, p = 0.04) in regard to reducing depression. There were no longer-term significant effects.
  • All types of psychosocial interventions were analyzed together, with no separate analysis based on the type of intervention. Only 35.7% of studies were considered to be of high quality.

Conclusions

Findings suggest that psychosocial interventions can be helpful in reducing anxiety and depression, at various time points in the cancer trajectory, for men who are newly diagnosed with prostate cancer. Positive effects were generally short-term only.

Limitations

  • In studies examining effect on depression, depression levels were low, causing one to question the clinical relevance of statistically significant findings.
  • No study required patients to have levels of depression that were clinically meaningful.
  • Authors noted that the majority of studies were of low quality and with small sample size. These factors limit the confidence one can have in the findings.
  • The analysis considered all types of very different interventions to be the same. This methodology did not allow researchers to determine the specific types of interventions that are truly most effective.
  • Studies involved very different intervention types, different timing and frequency of intervention or follow-up, and multiple types of patient care settings. These factors make interpreting overall effectiveness difficult.

Nursing Implications

Findings of this analysis suggest that various types of psychosocial interventions can help reduce anxiety and depression in men with prostate cancer. Effects shown tended to be short-lived. Nurses can help reduce anxiety and depression among patients with prostate cancer by using psychosocial types of strategies. Information about ways to sustain this effect is limited, and the analysis does not identify the types of approaches that are the most helpful. Further exploration of longer-term sustainable effects and associated dosage and intervention frequency is needed. Given the relatively low level of quality of research in this area, more well-designed studies are needed.

Print

Duijts, S.F., Faber, M.M., Oldenburg, H.S., van Beurden, M., & Aaronson, N.K. (2011). Effectiveness of behavioral techniques and physical exercise on psychosocial functioning and health-related quality of life in breast cancer patients and survivors—A meta-analysis. Psycho-Oncology, 20, 115–126. 

Purpose

STUDY PURPOSE: To examine the effects of behavioral techniques (e.g., behavioral therapy, cognitive therapy, mind-body and relaxation techniques, counseling, social support, hypnosis, biofeedback, exercise, physical exercise (PhysEx), aerobic exercise, physical activity, motor activity) on psychosocial functioning outcome measures, such as fatigue, depression, anxiety, body image, and stress, and on health-related quality of life

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Cochrane Library, PubMed, EMBASE, CINAHL, PsycInfo, SPORTDiscus. MeSH search terms included the examples of behavioral techniques named above, including physical exercise (PhysEx) terms and outcome measures, combined with the population terms breast cancer and breast neoplasm.
 
INCLUSION CRITERIA: Randomized, controlled trials of how any of the named behavioral techniques or PhysEx affected the outcomes of interest (fatigue, depression, anxiety, body image, stress) or healthcare quality of life. Reference lists were reviewed to identify additional potential articles. 
 
EXCLUSION CRITERIA: Articles were excluded if calculating the effect size or standard error was not possible with the available information.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 171 retrieved, 115 excluded because they were not randomized, controlled trials; they did not have enough quantitative data; the outcomes were not related to the current study; or their interventions were not related to the current study.
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: No evaluation of study quality was reported, although the authors reported evaluation of publication bias.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED =  56 studies: 39 studies of behavioral techniques; 14 studies of physical exercise; 3 studies of both 
  • TOTAL PATIENTS INCLUDED IN REVIEW = Not reported. This meta-analysis reported the number of patients by each randomized, controlled trial: 5,462 (behavioral intervention patients), 1,457 (PhysEx patients), 6,919 (total)
  • SAMPLE RANGE ACROSS STUDIES: 28–558 (behavioral intervention), 22–242 (PhysEx)
  • KEY SAMPLE CHARACTERISTICS: 33 studies of patients with nonmetastatic cancer, 4 studies of patients with metastatic cancer, 5 studies with a mix of patients

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care, palliative care

Results

The effect of these interventions on stress and anxiety were not consistently significant. In addition, publication bias on the outcome of behavioral techniques on depression and anxiety existed. Behavioral techniques showed positive (improvement) summary ejection fraction (EF) effect sizes on fatigue (14 studies: EF = –0.158,  p < 0.001), depression (23 studies: EF = –0.336, p < 0.001), anxiety (23 studies: EF = –0.346, p < 0.001), and stress (p = 0.038) scores, but not on body image scores (p = 0.051). Behavioral techniques had a small, insignificant effect on health-related quality of life (ES = 0.045, p = 0.322). PhysEx had a positive effect on fatigue (11 studies: EF = –0.315, p = 0.004), depression (6 studies: EF =  –0.262, p = 0.016) and body image (p = 0.007) but not on anxiety. PhysEx had a positive effect on health-related quality of life (ES = 0.298, p = 0.001). The effect size of PhysEx on stress could not be calculated. Publication bias was found for behavioral techniques on depression and anxiety. No publication bias was found for the effect of behavioral techniques on fatigue, body image, or stress. Publication bias was found for PhysEx on fatigue and health-related quality of life, but no publication bias was found for PhysEx on depression, anxiety, or body image.

Conclusions

Behavioral techniques affect specific aspects of psychosocial functioning but have a minor, insignificant effect on health-related quality of life. PhysEx has a positive effect on health-related quality of life. Behavioral techniques demonstrated a moderately significant effect on anxiety and depression and showed a significant but small effect on fatigue. PhysEx was effective for fatigue and showed a positive effect for depression.

Limitations

  • No quality evaluation
  • High heterogeneity
  • The variety of behavioral interventions made it challenging to select which was more effective than others (e.g., telephone counseling, telephone support, education, body-mind social support self-help, therapeutic groups by telephone, nurse self-efficacy).
  • Studies were included only through 2008—more recent evidence has shown some different findings.
  • High heterogeneity in behavioral technique analysis
  • The studies used a wide range of different measurements and interventions.

Nursing Implications

A range of behavioral techniques may be effective for patients with breast cancer and fatigue, depression, and depressed body image. PhysEx was shown to improve health-related quality of life, fatigue, anxiety, and depression. Recognizing the symptoms of patients with breast cancer was emphasized as having positive effects (e.g., feeling relieved, hearing helpful strategies addressing quality of life and psychosocial problems).

Print

Galway, K., Black, A., Cantwell, M., Cardwell, C.R., Mills, M., & Donnelly, M. (2012). Psychosocial interventions to improve quality of life and emotional wellbeing for recently diagnosed cancer patients. Cochrane Database of Systematic Reviews, 11, CD007064.

Purpose

To assess the effects of psychosocial interventions on quality of life and mood symptoms in patients diagnosed with cancer within the past 12 months

Search Strategy

  • Databases searched, up to January 2011, were Cochrane Central Register, MEDLINE EMBASE, CINAHL, and PsycINFO.
  • Authors provided an extensive listing of keywords and specific search strategies.
  • To be included, studies had to
    • Be randomized controlled trials (RCTs) or quasi-RCTs involving interpersonal dialog between a trained helper and individual newly diagnosed patients with cancer.
    • Measure quality of life and general psychological distress.
    • Include control groups that received standard care only.
  • Authors excluded trials involving a combination of psychosocial and pharmacologic interventions, as well as group- and couples-based interventions.

Literature Evaluated

  • A total of 3,272 references were retrieved.
  • Quality evaluation used criteria specified in the review for random allocation and allocation concealment, blinding, loss to follow-up, and assessment of reporting bias.

Sample Characteristics

  • Authors chose 30 trials to include, with 20 included in the meta-analysis.
  • The sample range across studies was 17–558, with a total sample across studies of 5,155.
  • All studies involved patients diagnosed within the past 12 months only.
  • Disease types included breast, colon, gastric, skin, prostate, and testicular cancers as well as, in some mixed trials, a few others.
  • All participants were adult patients.

Phase of Care and Clinical Applications

Multiple phases of care

Results

  • Anxiety outcomes were evaluated in four studies, depression outcomes were evaluated in six studies, and mood measures were evaluated in eight studies.
  • Analysis of studies involving mood measures resulted in a standard mean difference (SMD) of –0.81 (95% CI, 1.44, –0.18, p = 0.01) in favor of the intervention.
  • Analysis of quality-of-life outcomes showed mixed results with cognitive behavioral therapy, positive findings in favor of psychoeducational interventions (SMD = 0.29, 95% CI, 0.05, 0.54, p = 0.02), and no significant effects of counseling. Nurse-delivered interventions showed a significant positive effect (SMD = 0.23, 95% CI, 0.04, 0.43, p = 0.02) for quality of life. Interventions provided by a psychologist; general practitioner; and combined nurse, social worker, or others did not demonstrate significant effects.
  • No meta-analysis addressed the outcomes of anxiety or depression only.
  • Many studies were of relatively low quality, and the studies included substantial heterogeneity.

Conclusions

Findings suggest that psychosocial interventions have a positive impact on quality of life among newly diagnosed patients with cancer. Psychoeducational interventions and nurse-delivered interventions demonstrate a small significant effect across combined trials. Overall evidence does not indicate that individual psychosocial interventions are effective at improving the mood- and quality-of-life–related symptoms of patients newly diagnosed with cancer.

Limitations

A small number of studies in meta-analysis related to mood changes. Effect sizes in mood changes were small, and study samples comprised high heterogeneity, demonstrating that findings should be interpreted with some caution in terms of clinical relevance.

Nursing Implications

The fact that nurse-delivered psychosocial interventions demonstrated a positive and statistically significant effect is promising, although the effect size was small. This finding provides some support for interventions delivered by nurses rather than by other healthcare professionals. Other studies have reported this finding. Nurses may be uniquely positioned to provide such interventions: Their knowledge base includes both physiologic and psychosocial components of the cancer experience, and individual interventions can simultaneously and effectively address physical and psychosocial symptom management. The findings of this study provide general support for the effectiveness of psychoeducational interventions.

Print

Garcia, S. (2014). The effects of education on anxiety levels in patients receiving chemotherapy for the first time: An integrative review. Clinical Journal of Oncology Nursing, 18, 516–521. 

Purpose

PURPOSE: To synthesize evidence regarding the effectiveness of education for decreasing anxiety in patients receiving chemotherapy for the first time

TYPE OF STUDY: General review, semisystematic

Search Strategy

DATABASES USED: MEDLINE, CINAHL, ProQuest nursing and allied health source, Joanna Briggs Institute Clinical Online Network of evidence for care and therapeutics, Cochrane collaboration, and the National Guidelines clearing house
 
KEYWORDS: Patient education, health promotion, education intervention, chemotherapy, cancer, anxiety, treatment, management, and prevention
 
INCLUSION CRITERIA: Adult population; peer reviewed articles; and English language
 
EXCLUSION CRITERIA: Patients receiving radiation therapy or oral chemotherapy

Literature Evaluated

TOTAL REFERENCES RETRIEVED: Not reported
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The AGREE II, Critical Appraisal Skills Program, Joanna Briggs Institutue Meta-Analysis of statistics assessment and review instrument, and the Joanna Briggs narrative opinion and text assessment and review instrument

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 10 articles
  • TOTAL PATIENTS INCLUDED IN REVIEW = N/A (not all resources included were research studies or systematic reviews)
  • SAMPLE RANGE ACROSS STUDIES: N/A
  • KEY SAMPLE CHARACTERISTICS: Three references were related to patients receiving chemotherapy for the first time. Other references included general practice guidelines and expert opinions.

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

Three sources were guidelines, two were pilot studies, one was an evidence summary review, one was a systematic review, and one was an expert opinion. Most sources were of poor or fair quality. Not all the studies actually measured anxiety; some measured patient satisfaction. There was no differentiation made between the provision of educational and informational written materials and the provision of psychoeducation or cognitive behavioral therapy interventions.

Conclusions

This review provides minimal actual evidence regarding the effectiveness of educational interventions.

Limitations

A limited number of actual studies were included, and those included did not all address or measure anxiety.

Nursing Implications

Patient education prior to receiving chemotherapy is an essential aspect of patient care in providing an informed and empowered patient. The impact of education alone on anxiety is not clear, and this article does not provide substantial evidence or synthesis to clarify this potential effect of educational interventions.

Print

Hoon, L.S., Chi Sally, C.W., & Hong-Gu, H. (2013). Effect of psychosocial interventions on outcomes of patients with colorectal cancer: A review of the literature. European Journal of Oncology, 17, 883–891. 

Purpose

STUDY PURPOSE: To explore the effects of preoperative psychosocial interventions on the outcomes of patients with colorectal cancer, including measurements of physical, psychological, and social functioning, as well as quality of life
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE, CINAHL, Scopus, PsycINFO, Mednar, and Proquest
 
KEYWORDS: Psychosocial interventions for patients with colorectal cancer
 
INCLUSION CRITERIA: Research articles in peer-reviewed journals relevant to colorectal cancer with or without stoma formation in the adult population; articles related to any form of psychosocial intervention provided by healthcare professionals
 
EXCLUSION CRITERIA: Studies including pediatric patients and studies that involved patients with other forms of cancer

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 413
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Seventeen papers were deemed potentially relevant based on an assessment of titles and abstracts. Seven studies were excluded because they included participants with forms of cancer other than colorectal.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 11 
 
TOTAL PATIENTS INCLUDED IN REVIEW = About 300
 
KEY SAMPLE CHARACTERISTICS: Colorectal cancer, psychosocial intervention

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Pediatrics, elder care, palliative care

Results

Various psychosocial interventions, including educational interventions, cognitive behavioral therapy, relaxation training, and supportive group therapy, were found to reduce the length of patients’ hospital stays, decrease the number of days to proficiency in self-care for stoma, decrease levels hospital anxiety and depression, and increase quality of life.

Conclusions

Various forms of psychosocial interventions were used to improve outcomes, but no clear winner was found. All forms seemed to improve patient outcomes.

Limitations

  • A limited number of studies met the inclusion criteria.

Nursing Implications

Any type of psychosocial intervention seems to be worthwhile as none of the studies described in this analysis hurt a patient. Nurses can therefore safely recommend a psychosocial intervention to patients with colorectal cancer. Identifying areas of nursing research going forward is important.
Print

Howell, D., Harth, T., Brown, J., Bennett, C., & Boyko, S. (2017). Self-management education interventions for patients with cancer: A systematic review. Supportive Care in Cancer, 25, 1323–1355.

Purpose

STUDY PURPOSE: To identify core components of self-management education interventions and assess effectiveness

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: Ovid, MEDLINE, EMBASE, Cochrane collaboration, CINAHL, PsycINFO

INCLUSION CRITERIA: Adults, use of any type of teaching strategy, addressed any single core element of self-management interventions as defined by the authors, group based or individual structure

EXCLUSION CRITERIA: Psychotherapy or support groups, use of only information such as leaflets or videos, focus on family members, focus on decision making by patients, gray literature, interventions related to diet and exercise

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 4,579

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane risk of bias tool to evaluate study quality. All were at high risk of bias related to lack of blinding

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: 43 

TOTAL PATIENTS INCLUDED IN REVIEW: 6,795

SAMPLE RANGE ACROSS STUDIES: 22 to 483

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

Authors attempted to correlate core elements of interventions with outcomes. Overall, there were very few studies that had any common combinations of core elements, so this analysis could not be done. Overall, studies suggested that psychoeducational interventions may be beneficial for relieving symptoms of anxiety and depression. The content, elements, structure duration and frequency of interventions across studies were varied. Many interventions labeled as self-management education did not include components related to self management.

Conclusions

Psychoeducational interventions appear to be beneficial for symptoms of anxiety and depression. It is not possible to determine the specific components of these types of interventions that are most helpful.

Limitations

  • Mostly low quality/high risk of bias studies
  • High heterogeneity
  • Wide variation of the components, etc., of these types of interventions

Nursing Implications

Psychoeducational interventions of various types can be beneficial in reducing patients’ anxiety and depressive symptoms.

Print

Naaman, S.C., Radwan, K., Fergusson, D., & Johnson, S. (2009). Status of psychological trials in breast cancer patients: A report of three meta-analyses. Psychiatry, 72, 50–69.

Purpose

To determine the overall efficacy and magnitude of clinical benefit of psychological interventions in patients with breast cancer, specifically looking at three outcome variables: anxiety, depression, and quality of life (QOL)

Search Strategy

Databases searched were MEDLINE (1966–January 2004), EMBASE (1980–2004), Cochrane Controlled Trials Register (1985–February 2004), PsycLit (1973–2004), Biological Abstracts (1990–December 2003), CancerLit (1975–October 2002), CINAHL (1982–December 2003), and Health Star (1975–January 2004).

Search keywords were randomized clinical trial and breast cancer and psychological interventions (cognitive behavioral therapy, group psychotherapy, relaxation, supportive therapy, visual imagery) and psychological adjustment (anxiety, depression, maladjustment, distress, quality of life).

Studies were included in the review if they

  • Were a randomized clinical trial (RCT)
  • Included at least two arms: an intervention arm and a control arm
  • Evaluated the efficacy of a psychological/behavioral intervention
  • Were aimed at alleviating psychiatric/psychological morbidity, as defined by anxiety, depression, and/or QOL
  • Reported on female patients with a histologically confirmed diagnosis of breast carcinoma of any stage who have undergone surgery.

Trials examining efficacy of interventions designed to assuage surgical distress were excluded.

Literature Evaluated

  • A total of 383 citations were identified, with 36 potentially relevant articles identified and screened for retrieval.
  • The final meta-analysis included 18 RCTs with usable information by outcome.
  • Study quality was evaluated using a framework provided by Cook and Campbell (1979) and a quality assessment scale developed and validated by Jadad and colleagues (1996).

Cook, T.D., & Campbell, D.T. (1979). Quasi-experimentation: Design and analysis issues for field settings. Boston, MA: Houghton Mifflin.

Sample Characteristics

  • Fourteen trials assessing anxiety were identified, yielding a sample of 1,278 patients.
  • Fourteen trials measuring depression were identified, yielding a sample of 1,324 patients.
  • Seven trials measuring QOL were identified, yielding a sample of 623 patients.
  • Less than half of the trials included were considered to be of high methodological quality.
  • Patients’ ages ranged from 25 to 73 years, and approximately 70% were married or in a committed relationship.
  • Studies were conducted in the United States, Canada, England, Italy, Australia, Japan, and China.

Results

Anxiety

  • Overall effect size (ES) was -0.40 (95% CI, -0.72 to -0.08) in favor of the treatment condition in comparison to the control.
  • Sensitivity analyses exploring the impact of methodological quality on overall ES found a reduction in ES associated with higher quality studies, -0.26 (95% CI, -0.42 to -0.10).
  • Trials using patients with high morbidity (metastatic breast cancer) yielded a statistically significant overall ES of -0.40.
  • Trials whose treatment extended beyond 20 hours had a statistically significant overall ES of -0.30 in favor of treatment.
  • Treatment orientation showed differential impact on overall ES with cognitive behavioral therapy (CBT), yielding an ES of -0.11, as well as ESs of -0.40 for guided imagery and relaxation, -0.43 for supportive-expressive therapy, and 0.02 for educational interventions.

Depression

  • Overall ES for depression was -1.01 (95% CI, -1.48 to -0.54) in favor of treatment.
  • Trials with higher methodological grade were associated with an overall ES of -0.24 in favor of treatment, while lower quality studies had an overall ES of -1.99.
  • Studies in which patients had lower morbidity yielded an overall ES of -0.45, whereas those with patients with more advanced disease yielded an overall ES of -1.20.
  • Couples and group therapy reached statistical significance with an ES of -1.02 and -1.35, respectively.
  • Treatment orientation showed ESs of -0.85 for CBT, -0.55 for guided imagery, -1.80 for supportive expressive therapy, and -0.45 for educational interventions. With the exception of educational interventions, the other subgroup analyses reached statistical significance.

Quality of Life

  • Overall ES was 0.74 (95% CI, 0.12 to -1.37) in favor of the treatment group, but this was not statistically significant. When lower quality studies were removed, statistical significance was achieved, but ES was reduced (0.35, p=0.04).

Conclusions

Overall ES trends among the three outcomes show that more reliable studies were associated with smaller gains. Interventions targeted to patients with clinically important levels of anxiety or depression tended to reap the most benefit, compared to patients who undergo treatment on a prophylactic basis. Group psychotherapy appears to be superior to individual therapy in the treatment of both anxiety and depression. However, a direct impact of group therapy on QOL was not supported in this analysis. CBT interventions appeared to be equally as effective as supportive-experiential therapies. Interventions need not span beyond 20 hours to produce statistically significant ES.

Limitations

The quality of most studies was not high.

Nursing Implications

Future trials in psychosocial oncology should incorporate methodological features to enhance internal validity. Evaluation of statistically significant findings on psychometric testing may not reflect clinically significant findings and vice versa. This underscores the need for incorporating qualitative analysis in future studies. There is an absence of studies examining the efficacy of short-term interventions on QOL in advanced breast cancer and should be addressed in future research. Short-term, group interventions may provide the best utilization of scarce resources for the most effect; however, they should be targeted to those patients experiencing clinically important levels of distress. Findings point to the need for higher quality research design and reporting in this field.

Print

Osborn, R.L., Demoncada, A.C., & Feuerstein, M. (2006). Psychosocial interventions for depression, anxiety, and quality of life in cancer survivors: Meta-analysis. International Journal of Psychiatry in Medicine, 36, 13–34.

Purpose

To investigate the effects of cognitive behavioral therapy (CBT) and patient education (PE) on anxiety in adult cancer survivors

Search Strategy

Databases searched were MEDLINE, PsycINFO, and the Cochrane Database (1993–2004).

Search keywords were cancer, anxiety, depression, quality of life (QOL), fatigue, stress, pain, physical function, social, self-management, evidence-based, interventions, and random/randomized.

Studies were included in the review if they

  • Reported on adult patients with cancer (all types and stages)
  • Had a control group, randomization, and measurable outcomes of interest (anxiety, depression, fatigue, QOL, physical function, and pain)
  • Had at least one follow-up assessment beyond post-treatment, which allowed for examination of duration of effects.

Studies were excluded if they were not randomized or controlled, had a score of less than four on checklist, did not report follow-up data, or did not report data on targeted outcomes.

Dissertations were excluded.

Literature Evaluated

  • A total of 592 studies were evaluated, with only 19 studies meeting criteria. Comprehensive meta-analysis was used to determine effect size for each outcome.
  • Quality was assessed by a modified version of Jadad’s six-item checklist (randomization, double blinding, descriptions of withdrawals and dropouts, statistical analyses, inclusion and exclusion criteria, and adverse effects).
  • Longitudinal study: Times of measurement varied from one week to 14 months. Median follow-up was defined as short-term (less than eight months) and long-term (more than eight months).
  • Four studies reviewed used CBT for anxiety.
    • CBT sessions varied from four weekly one-hour sessions to 55 weekly two-hour sessions.
    • CBT included stress management and problem-solving approaches.
  • One study reviewed used PE for anxiety.
    • PE sessions varied from one 20-minute session to six weekly one-hour sessions.
    • PE included information about illness, symptom management, and discussion of treatment options using booklets, videos, and other educational materials.

Sample Characteristics

  • The review reported on 1,492 adult cancer survivors.
  • All types and stages of cancer were represented.
  • Survivor age range was 18–84 years.
  • 790 survivors were assigned to interventions, and 702 were assigned to control (medical management only).

Results

  • CBT interventions on anxiety (four studies):
    • Large effect was noted for individual and group CBT (g = 1.99, p < 0.01; 95% CI 0.69–3.31).
    • Of these four studies, a sensitivity analysis revealed a large effect size for individual treatment (g = 2.41, p < 0.01; 95% CI 1.2–3.55) and no effect for group interventions (d = 0.03, p+0.82; 95% CI -0.20–0.25).
    • Forest plots representing the effect sizes of CBT on anxiety favor the intervention.
  • The single trial using PE to decrease anxiety resulted in no short-term effect on anxiety and did not include long-term follow-up on anxiety (d= -0.02, p = 0.89; 95% CI -0.36–0.31).

Limitations

  • Analysis did not consider patient adherence to pharmacologic interventions, which is known to be modest in medical patients.
  • No cost-benefit implications were noted.

Nursing Implications

CBT is effective for short-term management (less than 8 months) of anxiety. Individually based interventions were more effective than those delivered in a group format. Various CBT approaches provided in an individual format can assist cancer survivors in reducing the emotional distress of anxiety.

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Preyde, M., & Synnott, E. (2009). Psychosocial intervention for adults with cancer: A meta-analysis. Journal of Evidence-Based Social Work, 6, 321–347.

Purpose

To evaluate types of psychosocial interventions employed in patients with cancer

To update and extend a previous review by conducting a search and reporting on recent trials

Search Strategy

Databases searched were MEDLINE, CINAHL, PsycINFO, Social Sciences Citation Index, Social Services Abstracts, and PubMed databases from 1999–2007.

Search keywords were psychosocial care, intervention, service, support, oncology, effectiveness (effect*) and evaluation (evaluat*).

Studies were included in the review if they reported

  • Any type of psychosocial intervention delivered during the treatment phase of cancer
  • Primary cancer of any histological type
  • A randomized controlled trial (RCT) or quasi-experimental design
  • Measurements of one or more intended effects of psychosocial intervention
  • An English-language samples of patients age 18 or older.

Studies were excluded if they reported on patients with metastatic disease.

Literature Evaluated

A total of 1,702 studies were initially identified. After elimination of studies that did not meet inclusion criteria, 27 studies were included. Study quality was evaluated using a modified Jadad scoring approach. There were 22 final RCTs and 5 pilot studies used.

There were few studies with a high-quality rating, and the mean rating for the entire sample of studies was 2.41 on a 5-point scale. Effect sizes were calculated for only nine studies, in which statistically significant results were reported. Patient outcomes measured in this subgroup of studies varied and included general health, emotional control, social support, global adjustment to illness, relationship quality, optimism, self-esteem, and self-efficacy. Studies were conducted in the United States, Canada, Europe, Hong Kong, Australia, and New Zealand.

Sample Characteristics

  • Across the final set of 27 studies, sample sizes reported ranged from 17 to 260, with a total of more than 3,600 patients.
  • Breast cancer was the most common diagnosis.
  • Studies also included melanoma, gynecologic, head and neck, lung, colon, prostate, and other cancer types.

Results

The mean effect size was small, at 0.28, across the varied outcomes measured in studies. 

Individual interventions: psychosocial, psychoeducational, and cognitive behavioral

  • Nine studies examined the effect of psychosocial counseling.
    • Three studies demonstrated mixed results, with negative effects.
    • Two studies did not report actual statistical findings.
    • Three studies did not demonstrate statistically significant findings. 
    • One study demonstrated significantly better scores for self-administered stress reduction on some general health and depression scales compared to controls and those in a professionally led intervention.
    • One small pilot study reported significant improvement in body image perception.
  • Four studies used cognitive behavioral interventions.
    • One study reported mixed results.
    • Two studies did not find statistically significant results. In one of these, there was no main effect, but symptoms improved more in a subgroup of patients who had more severe symptoms at baseline.
    • One study demonstrated significant differences in anxiety and perceived social support.

 Telephone intervention

  • Four studies used telephone interventions primarily to address educational and resource needs.
  • Only one of these studies showed a trend toward improvement in depression and fatigue; however, there were unadjusted differences between groups at baseline.

Group counseling

  • Four studies tested group interventions. Three of these did not find significant differences between groups, and one study reported significant effects on psychological distress at 6 months, but not at 12 months.

Miscellaneous

  • One study reported significant differences in relationship quality with couples counseling and psychological distress, but only at a 1 week time point in the study.
  • One study examined the effect of feedback to the physician regarding patients’ distress. No significant effects were found.

Attrition was a problem in many of the studies. In a few studies, positive effects or trends were seen with individuals who had more severe problems at baseline; however, attrition was also highest among these patients.

Conclusions

There appears to be some evidence supporting interventions targeting stress and coping; however, there is no strong support for any one type of intervention evaluated here. Where significant findings were seen, effect sizes were small and the clinical relevance of this level of effect could not be evaluated. There do not appear to be any long-term effects with the interventions examined here.

Limitations

The quality of most studies was not high.

Nursing Implications

While no long-term effects were clearly found, even short-term effects on distress for people with cancer can be important for patients and clinically useful.

Positive results in one study using self-managed approaches for stress reduction suggest that this may be a practical and cost-effective way to address short-term patient needs.

Patients with cancer are a heterogeneous group, and the nature of psychosocial interventions is such that one should expect them to be highly individualized, as is the approach in clinical practice. Further, psychosocial interventions delivered on an individual basis versus group therapy were better supported and easier to maintain. This represents one of the challenges in this area of research that should be addressed in future studies.

Given attrition levels discussed here along with findings that greater effect is seen among patients with more severe baseline problems, in future work, care needs to be taken to consider for whom psychosocial interventions is indicated and how onerous the intervention and study protocol are for participants.

Findings point to the need for higher quality research design and reporting in this field.

Psychoeducational interventions addressing patients’ informational needs about cancer, progression, treatment, and side effects were found to be beneficial.

Psychosocial interventions found to be most beneficial include cognitive adaption, coping management, and encouraging patients to practice stress management techniques at home.

Print

Renouf, T., Leary, A., & Wiseman, T. (2014). Do psychological interventions reduce preoperative anxiety? British Journal of Nursing, 23, 1208–1212.

Purpose

STUDY PURPOSE: To evaluate evidence regarding effects of psychoeducational interventions for preoperative anxiety

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: CINAHL, MEDLINE, PsycINFO, Behavioral Science Index, British Nursing Index
 
KEYWORDS: anxiety, preoperative, non verbal, nurse, active listening
 
INCLUSION CRITERIA: Adult patient samples, measuring preoperative anxiety, primary research publication
 
EXCLUSION CRITERIA: None specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 348
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: States a combination of tools used to evaluate studies, since studies using different designs were included; however, no specific report of study quality is given.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED  =  13
  • TOTAL PATIENTS INCLUDED IN REVIEW: Not provided
  • SAMPLE RANGE ACROSS STUDIES: Not provided
  • KEY SAMPLE CHARACTERISTICS: Not provided, although report does state inclusion of patients with cancer

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

The report suggests that nursing interventions of a psychoeducational nature can reduce preoperative anxiety, based on findings of six randomized, controlled trials conducted from 1985 to 2005. Samples in these studies were self-selected, and the review identifies a number of study design aspects that would create risk of bias, inappropriate statistical analysis, and high volume of missing data and elimination of patients from data analysis. The review also stated that patients benefit from individualized information and have associated reduction in anxiety; however, review of these studies also suggested multiple design flaws, and this finding appears to be based on various authors’ recommendations rather than actual study findings.

Conclusions

There are multiple limitations of this review, and it does not provide strong support for effectiveness of various nursing interventions to reduce preoperative anxiety.

Limitations

No information is provided about study sample types or actual quality of studies included. Findings stated in the article are not clearly derived from actual research results.

Nursing Implications

Due to study limitations, this review does not provide strong support for the efficacy of psychoeducational and informational interventions to reduce preoperative anxiety. Provision of preoperative patient education is a necessary component of care, but it may not be sufficient to alleviate anxiety.

Print

Tao, W.W., Jiang, P., Liu, Y., Aungsuroch, Y., & Tao, X.M. (2014). Psycho-oncologic interventions to reduce distress in cancer patients: A meta-analysis of controlled clinical studies published in People's Republic of China. Psycho-Oncology, 24, 269–278. 

Purpose

STUDY PURPOSE: To summarize and analyze the results of controlled studies published in China to assess the effects of psycho-oncologic interventions on distress in patients with cancer 
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: China National Knowledge Infrastructure, Chinese Scientific Journal Database, Wanfang Database, PubMed
 
KEYWORDS: Chinese terms for psychology, distress, anxiety, depression, and terms related to cancer and interventions including training, group therapy, meditation, and music therapy
 
INCLUSION CRITERIA: Randomized, controlled trials and nonrandomized, controlled studies; patients greater than 18 years old

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,398
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The Jadad Scale for Reporting Randomized Controlled Trials was used to determine the risk of bias. Only those studies scoring > 2 on the Jadad scale were included in this meta analysis.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 207 (qualitative synthesis), 31 (meta-analysis)
 
TOTAL PATIENTS INCLUDED IN REVIEW = 3,007 
 
SAMPLE RANGE ACROSS STUDIES: The median sample size was 48 patients.
 
KEY SAMPLE CHARACTERISTICS: Multiple tumor types were included and the median age was 50.85 years. The majority of studies were conducted in women diagnosed with breast cancer.

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

Intervention types that were included in the meta-analysis were educational, psychological support, cognitive behavioral therapy, relaxation training, music therapy, coping skills training, and communication skills training. The majority of studies incorporated two or more interventions together. Fifteen studies showed overall significant effects on anxiety (d = -8.71, p < .001). The combination of education and psychological support (d = -8.17, p = .04) or education combined with relaxation training (d = -12.95, p < .001) were effective in reducing anxiety. Large combined effects were seen on depression (d = -8.12, p < .001). No analysis of effects for specific intervention types was possible. In greater than 69% of studies, the interventions were performed by nurses.

Conclusions

The findings of this study support the effectiveness of psychoeducational interventions to reduce anxiety and depression in patients with cancer in China.

Limitations

The studies included in this analysis had numerous flaws. The meta-analysis was primarily done across all types of interventions. Because most of the studies used combined interventions, the effectiveness of individual components could not be determined. The authors noted that the trials were carried out in Chinese regions where almost no negative studies are reported, so publication bias cannot be ruled out.

Nursing Implications

The findings of these studies support the effectiveness of psychoeducational interventions for anxiety and depression in patients with cancer. Although these findings were only in Chinese patients, they are in agreement with the bulk of overall evidence in this area. These results suggest that psychoeducational interventions are likely to have similar levels of effectiveness in various cultural groups.

Print

Yang, Y.L., Sui, G.Y., Liu, G.C., Huang, D.S., Wang, S.M., & Wang, L. (2014). The effects of psychological interventions on depression and anxiety among Chinese adults with cancer: A meta-analysis of randomized controlled studies. BMC Cancer, 14, 956-2407-14-956. 

Purpose

STUDY PURPOSE: To assess the effects of psychological interventions on depression and anxiety in Chinese adults with cancer 
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: China National Knowledge Infrastructure, Wangfang database, Vip, Chinese Biomedical Literature, PubMed, and Web of science
 
KEYWORDS: Psychotherapy MeSH terms, cancer terms, depression, and anxiety
 
INCLUSION CRITERIA: Subjects aged 16 years and over; randomized, controlled trials with samples of at least 30; depression and anxiety measured with validated tools; subjects from mainland China
 
EXCLUSION CRITERIA: Subjects in Hong Kong, Taiwan, or Macao; unclear descriptions of the interventions; studies with insufficient data to calculate effect sizes; use of nonpsychological interventions including medicine; patients in hospice or terminal home care

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 2,134
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The authors modified the Jadad scale for study quality assessment, eliminating the evaluation of blinding and adverse effects.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 143
  • TOTAL PATIENTS INCLUDED IN REVIEW = 14,039
  • SAMPLE RANGE ACROSS STUDIES: 30–326 patients
  • KEY SAMPLE CHARACTERISTICS: Most studies included patients with various types of cancer.

Results

The meta-analysis was completed using all studies in a single analysis. The interventions were highly varied, including patient education, relaxation, cognitive behavioral therapy, etc. An analysis showed an overall effect size of SMD = 1.199 (95% CI 1.095 – 1.303, p < 0.001) for depression in 122 studies and an overall effect size SMD = 1.298 (95% CI 1.187-1.408, p < 0.001) for anxiety in 131 studies. There was high heterogeneity in the analysis. An analysis showed a significant publication bias for both depression and anxiety. A subgroup analysis showed significant effects of cancer type, patient selection, intervention format, and the method of measurement used in moderating results. The findings of this analysis suggested that interventions appeared to be more useful for patients with increased levels of psychological distress.

Conclusions

The findings of this review suggest that various psychological interventions can benefit patients with cancer dealing with symptoms of anxiety and depression.

Limitations

The major limitation of this analysis was that the meta-analysis was done considering all studies together. This is questionable because it is difficult to see interventions such as cognitive behavioral therapy as equivalent to general patient education or relaxation techniques. The analysis showed high heterogeneity, which is not surprising given the range of interventions considered together and the variety of types of patients. The high risk of publication bias also limits the potential validity of these findings. Reports were restricted to studies involving patients from mainland China, so it is unclear if the findings would be applicable to other cultural groups. Databases outside of China were limited.

Nursing Implications

This meta-analysis did not provide substantial or useful support for various types of interventions aimed at managing the symptoms of depression and anxiety. To determine which interventions are most effective as supported by evidence, the interventions that are very similar if not exactly the same must be grouped for analysis. This was a major limitation of this report, and it is reflected in its high heterogeneity. Its findings need to be viewed with some caution given the limitations of this study.

Print

Zweers, D., de Graaf, E., & Teunissen, S.C. (2015). Non-pharmacological nurse-led interventions to manage anxiety in patients with advanced cancer: A systematic literature review. International Journal of Nursing Studies, 56, 102–113. 

Purpose

STUDY PURPOSE: To provide a non-pharmacologic nurse-led intervention inventory for effectively managing anxiety in patients with advanced cancer. 
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: CINAHL MEDLINE, PsychINFO, and Cochrane
 
KEYWORDS: For patients: carcinoma, neoplasm, advanced or incurable cancer, or metastasis. For intervention: palliative care or social support or Imagery, or complementary therapies, or self-care, or cognitive behavior therapy, or spiritual therapy, or aromatherapy, or art therapy, or music therapy, or holistic health, or holistic counseling, or psychotherapy, or nurses, or nursing care, or hospice care, or terminal care, or palliative care, or social support, or terminal cancer, or family support, or guided imagery, or best supportive care, or psychosocial support.  For outcomes: quality of life or anxiety, or fear, or anxiety disorder, or quality of dying
 
INCLUSION CRITERIA: Randomized, controlled trials (RCT) that included patients diagnosed with metastatic cancer regardless of stage of cancer, and location of care, and written in English. Interventions were aimed as anxiety as a symptom. Studies were included if they reported separate results for anxiety as a symptom.  
 
EXCLUSION CRITERIA: Studies with patients who had a diagnosis of anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV). Studies that had no full text even after emailing the first author were excluded.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,550
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: PRISMA used to exclude duplicates, exclusions based on title, exclusion based on abstract, no full-test availability, and exclusions based on patients, intervention, outcomes, or method.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED; N (studies) = seven 
  • TOTAL PATIENTS INCLUDED IN REVIEW:  706
  • SAMPLE RANGE ACROSS STUDIES: 24-189 patients
  • KEY SAMPLE CHARACTERISTICS: A majority of patients were in the outpatient setting. Studies were published from 1999 to 2013.

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Palliative care

Results

Four of seven interventions were educational. In some studies, education was combined with telemonitoring or progressive muscle relaxation. Counseling and coaching as self-care strategies for monitoring symptoms were evident in two studies. Two studies focused on expressive writing, and focused narrative interview. One study compared aromatherapy with massage. Interventions were performed by nurses and research nurses, with or without training.  Duration of interventions ranged from 1-3 contacts in one week to six months. Contacts were face-to-face or by telephone. None of the studies documented patient adherence to the interventions. The development of the interventions was limited to literature review. Two studies showed significant differences between the intervention and control group at six months (telemonitoring combined with education). One study did not show significance between the control and intervention groups at one week. A study of progressive muscle relaxation showed significance in anxiety at week 6 and week 12. No significant effect on anxiety was found between aromatherapy and massage. There was significantly decreased anxiety after each massage. This was also seen in a study that focused on narrative interview.

Conclusions

Although some of the studies described showed some significance, all had limitations. Studies are scarce; only seven met the inclusion criteria.

Limitations

Some studies had a high attrition rate. The authors defined several areas of bias including selection, performance, attrition, and reporting. There was limited information regarding development of interventions. There was not enough information on any one intervention to be able to clearly to implement it as evidence.

Nursing Implications

Evidence regarding nonpharmacologic nursing interventions for anxiety is scarce. More nursing research is indicated, including well-developed interventions.

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Research Evidence Summaries

Badr, H., Smith, C.B., Goldstein, N.E., Gomez, J.E., & Redd, W.H. (2015). Dyadic psychosocial intervention for advanced lung cancer patients and their family caregivers: Results of a randomized pilot trial. Cancer, 121, 150–158. 

Study Purpose

To test the initial efficacy, acceptability, and feasibility of a dyadic (patient–caregiver) psychosocial, phone-delivered intervention to improve the quality of life of the families of patients with advanced lung cancer within one month of the first cancer treatment

Intervention Characteristics/Basic Study Process

The dyads were randomly assigned to a usual medical care (UMC) or a six-week intervention group. Intervention patients and caregivers received separate standardized, tailored manuals. Manuals addressed self-care, stress and coping, symptom management, effective communication, problem solving, and maintaining and enhancing relationships. Patients and caregivers shared half of the topic information, but other content was tailored to the patient or caregiver role. Patients-tailored content included ways to balance autonomy with asking for and accepting support, sharing support needs, and ways to show caregiver appreciation. Caregiver-tailored content included ways to minimize patient overprotection, show effective communication, and ways to support patient self-care goals. Intervention dyads participated in six weekly 60-minute telephone counseling sessions aimed at alleviating caregiver burden with a trained interventionist who reviewed weekly patient and caregiver homework and manual content. The interventionist mentored participants through sessions and homework assignments to reinforce session skills for patients and caregivers. Participants in UMC and intervention groups completed six paper-and-pencil surveys at baseline and eight-weeks after baseline.

Sample Characteristics

  • N = 39 patient–caregiver dyads (20 dyads in intervention group, 19 dyads in UMC group)
  • MEAN AGE = Patients; 68.17 years (SD = 10.30 years, range = 38–87 years), caregivers; 51.10 years (SD = 10.24 years, range = 35–70 years)
  • MALES: Patients (26%); caregivers (31%), FEMALES: Patients (74%); caregivers (69%)
  • KEY DISEASE CHARACTERISTICS: 84% of sample had stage 3 or 4 non-small cell lung cancer; 16% had extensive-stage small cell lung cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients were mostly white (85%) and educated with at least some college credits (86%); 62% was unemployed or retired; caregivers were mostly female (69%) and educated with at least some college credits (95%); most were middle-aged (mean = 51.10 years, SD = 10.24 years) and employed at least part- time (77%); 51% of caregivers were spouses or partners, and others were siblings or the adult sons and daughters of patients

Setting

  • SITE: Single site
  • SETTING TYPE: Outpatient oncology and palliative care clinic  
  • LOCATION: New York City comprehensive cancer center with range of services

Phase of Care and Clinical Applications

  • PHASE OF CARE: Advanced lung cancer within one month of treatment initiation (any form of therapy)
  • APPLICATIONS: Elder care and palliative care 

Study Design

Randomized clinical trial

Measurement Instruments/Methods

All the instruments assessed and held high reliability and validity; patients and caregivers completed these instruments independently of one another.
  • Six-item Patient Reported Outcomes Measurement Information System (PROMIS), a short-form depression measure to assess the negative moods and views of self for the past week
  • Two-item Zarit Burden Interview (ZBI) Short Form 
  • Six-item Treatment Self-Regulation Questionnaire (TSRQ) to assess patient autonomy for engaging in self-care
  • Five items developed by Pierce et al. used to assess caregivers’ autonomous motivation
  • 38-item Likert scale measure based on the work of Lorig et al. (1996) used to measure competence (self-efficacy)  
  • Four-item measure used to measure relatedness (quality of the caregiver-care recipient relationship)

Results

At baseline, 33% of patients and 60% of caregivers had PROMIS depression T-scores > 60 (SD = 11), indicative of high levels of depression. About a quarter of dyads scored higher than 60. At baseline, 46% of patients and 69% of caregivers had PROMIS anxiety T-scores > 60, reflective of high levels of anxiety. More than a third of dyads scored higher than 60.

The study's recruitment rate was 60%, which is comparable to rates reported in other telephone-based cancer dyadic interventions, supporting the feasibility of recruiting advanced LC patients on active treatment and their caregivers for this trial. Patient and caregiver telephone-session participation was 90%. Participants rated the intervention as relevant, convenient, and helpful. Retention was excellent, and dyads completed the majority (88%) of homework assignments. This suggests a highly acceptable intervention. Large effect sizes were found for the impact of the intervention on outcomes of patient and caregiver depression, anxiety, and caregiver burden as contrasted with UMC group outcomes. Large effect sizes for impact of the intervention were also found for additional patient and caregiver outcomes relevant to competence and relatedness and caregiver free choice to provide patient care. Highly depressed and anxious caregivers, identified at the baseline assessment in the intervention group, showed greater improvements in psychological functioning than did those in the UMC group.

Conclusions

This pilot study demonstrated the feasibility and acceptance of a six-session, telephone-based dyadic psychosocial intervention developed for patients with advanced lung cancer and their caregivers and its positive effects on their rates of depression, anxiety, and caregiver burden.

Limitations

  • Small sample (< 30)
  • Baseline sample/group differences of import
  • Measurement/methods not well described
  • Other limitations/explanation: Sample was primarily white and was relatively well-educated; the ability to generalize findings to other populations was limited

Nursing Implications

Telephone-based interventions addressing patients with late-stage lung cancer and their caregivers may improve overall dyadic quality of life. This study indicated support for separate patient and caregiver sessions to address private issues posing challenges in a dyadic discussion. Additional research focused on separate sessions balanced with dyadic sessions may strengthen the evidence for telephone interventions.

Print

Barth, J., Delfino, S., & Kunzler, A. (2013). Naturalistic study on the effectiveness of psycho-oncological interventions in cancer patients and their partners. Supportive Care in Cancer, 21, 1587–1595.

Study Purpose

To explore the effectiveness of psycho-oncologic interventions for patients and partners on anxiety, depression, psychopathology, and distress

Intervention Characteristics/Basic Study Process

Patients and partners who had been referred for psycho-oncologic service were recruited. Common interventions were psychoeducation, cognitive restructuring, behavior control techniques, guided imagery, relaxation, couples communication training, and other types of counseling in an individualized, nonstandard fashion. Patients and partners were grouped according to propensity scores calculated from variables shown to be significant in regression analysis for outcomes of interest, including gender, age, cancer site, stage of disease, baseline anxiety, and depression. Propensity matched control patients, and partners who did not receive the intervention were identified and used as control comparisons. Analysis was done in groupings according to the level of distress with propensity scores as low-, moderate-, or high-distress.

Sample Characteristics

  • N = 66 patients and 45 partners in ITT analysis; 43 patients and 27 partners completed the study  
  • MEAN AGE = 57.8 years (SD = 14.2 years) for patients, 56 years (SD = 14.4 years) for partners in the intervention
  • MALES: 60.6% for patients, 26.1% for partners; FEMALES: 39.4% for patients, 73.9% for partners
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types—hematologic, head and neck, and gastrointestinal most common; 63.6% of patients had stage 3 or 4 disease; 69.5% of partners were involved with stage 3–4 disease
  • OTHER KEY SAMPLE CHARACTERISTICS: In most areas, patients in the control group did not have significant differences from those in the treatment groups. However, the majority of patients in the control group were highly educated, with 24% at the university level. Educational characteristics of patients and partners in the intervention group were not reported. Note: Sample characteristics are those who were moderately distressed. All characteristics of the full sample across all groups are not clearly provided.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Germany

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care 

Study Design

  • Naturalistic design
    • Quasi-experimental with matched control comparison

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • Symptom checklist (nine psychological symptoms)
  • Global Severity Index for overall psychopathology

Results

Time effects within patient groups showed significant decreases over time in depression and distress (p ≤ .05), but not for anxiety and psychopathology. No group effects were seen on outcomes over time. Among partners, no changes were seen over time and no significant effects of the intervention were seen on outcomes. The same pattern was seen in completer and intent to treat analysis. Pre- and post-intervention data showed that patients had significant declines in anxiety (effect size Cohen’s d = 0.32, p = .01), distress (d = .46, p = .001), and depression (d = 0.52, p = .001) at 12 months, and partners had significant declines in anxiety (d = 0.45, p = .01) and distress (d = .42, p = .02) within the highly distressed group. No significant differences were seen in the less distressed group over time.

Conclusions

Findings suggest that psychotherapeutic interventions can reduce anxiety, distress, and depression among patients and partners who are highly distressed. Little benefit may exist for individuals who are less anxious or distressed at baseline.

Limitations

  • Small sample (less than 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Questionable protocol fidelity
  • Other limitations/explanation: Distress measurement and definition are not described. The matched controls were not completely described but were highly educated; the education level of the comparison group is unknown. The intervention was not standardized or reviewed for content, so one cannot determine the similarities or dissimilarities of intervention sessions.

Nursing Implications

Psychotherapeutic interventions may be beneficial for patients and caregivers who are highly distressed. Nurses need to be aware of the overall level of patient and caregiver distress and identify those who are likely to benefit from referral for therapy.

Print

Bourmaud, A., Anota, A., Moncharmont, C., Tinquaut, F., Oriol, M., Trillet-Lenoir, V., . . . Chauvin, F. (2017). Cancer-related fatigue management: Evaluation of a patient education program with a large-scale randomised controlled trial, the PEPs fatigue study. British Journal of Cancer, 116, 849–858.

Study Purpose

To evaluate the effectiveness of a psychoeducational program on cancer-related fatigue

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to the study intervention or usual care. Patients in the intervention group (PEPs) received written information explaining cancer-related fatigue and difference approaches for management. Patients in this group were also encouraged to participate in five group educational sessions of two hours each over a six-week period. The PEPs content was designed to incorporate NCI and CPEN guidelines. Content included information about the disease, fatigue, self expression of attitude, coping strategies, and skill development for managing fatigue. Educational teams received a two-day intensive training to standardize program content. Patients in the control group received the written documentation as described. After the study, patients in the control group were offered participation in the program.

Sample Characteristics

  • N = 129   
  • AGE: Mean = 55.9 years
  • MALES: 15.6%  
  • FEMALES: 84.4%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types–over 60% were breast cancer cases. Average of slightly less than one month since diagnosis.
  • OTHER KEY SAMPLE CHARACTERISTICS: Mean baseline fatigue was 5 in both groups.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: France

Study Design

RCT

Measurement Instruments/Methods

  • Numeric rating scale for fatigue intensity
  • FACT-Fatigue
  • Piper Fatigue Scale
  • EORTC-QLQ-C30
  • Hospital Anxiety and Depression Scale

Results

There were no differences between groups in fatigue scores after the intervention, and no differences in the trajectory of fatigue. Fatigue declined overall in all patients. There were no differences between groups in anxiety or depression.

Conclusions

The educational program tested here did not demonstrate an effect on fatigue, anxiety, or depression.

Limitations

  • Risk of bias (no appropriate attentional control condition)
  • Questionable protocol fidelity
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Authors questioned the possibility of study group contamination since all patients were treated at the same clinical centers. No observations to check program fidelity were described. Phase of care is not clear in this report. Question of author bias–authors attribute lack of apparent effect to the need for better fatigue measures.

Nursing Implications

Psychoeducation is an intervention that has shown mixed results for impact on cancer-related fatigue and other symptoms. The specific program tested here did not demonstrate an effect. Fatigue in particular is a complex multifaceted symptom. Various psychoeducational and supportive approaches have also been complex in terms of design, content, timing, dose, etc. The effectiveness of psychoeducational-type interventions may relate to all of these aspects of both content and delivery.

Print

Bruera, E., Yennurajalingam, S., Palmer, J.L., Perez-Cruz, P.E., Frisbee-Hume, S., Allo, J.A., . . . Cohen, M.Z. (2013). Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer: A randomized, placebo-controlled, phase II trial. Journal of Clinical Oncology, 31(19), 2421–2427. 

Study Purpose

Compare the effects of methylphenidate (MP) (psychostimulant) with those of a placebo (PL) on cancer-related fatigue. The effect of a combined intervention including MP plus a nursing telephone intervention (NTI) also was assessed.

Intervention Characteristics/Basic Study Process

Patients with a fatigue score of greater than or equal to 4 out of 10 on the Edmonton Symptom Assessment Scale (ESAS) randomly were assigned to one of the following four groups: MP plus NTI, PL plus NTI, MP plus control telephone intervention (CTI), and PL plus CTI.

Sample Characteristics

  • N = 141
  • MEDIAN AGE = 58 years
  • MALES: 33%, FEMALES: 67%
  • KEY DISEASE CHARACTERISTICS: Diagnosis of advanced cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Four or above on the ESAS, normal score on the Mini Mental State Examination (MMSE), no severe comorbid conditions including severe anxiety, major depression, substance abuse, or erythropoietin use

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Outpatient palliative care and oncology clinics at MD Anderson Cancer Center and at Lyndon B. Johnson General Hospital, both in Houston, TX

Phase of Care and Clinical Applications

  • PHASE OF CARE: Mutliple phases of care
  • APPLICATIONS: Pediatrics, elder care, palliative care

Study Design

Randomized, controlled trial; placebo controlled

Measurement Instruments/Methods

  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
  • ESAS
  • MMSE
  • Hospital Anxiety and Depression Scale (HADS)
  • Pittsburgh Sleep Quality Index (PSQI)

Results

The groups MP alone, NTI alone, or MP plus NTI proved not significantly better than PL for cancer-related fatigue. Anxiety improved with the telephone intervention (p = .01), as did sleep (p < .001).

Conclusions

MP, used alone or in combination with NTI, was not superior to the control group or the PL for fatigue or depression. NTI was associated with improvement in anxiety and sleep.

Limitations

  • Risk of bias (no blinding)
  • No statistical control for multiple comparisons, which could lead to a type one error
  • Limited duration of two weeks  
  • Content of CTI not described

Nursing Implications

Although the use of MP did not prove to be effective for cancer-related fatigue, several cancer-related symptoms significantly were improved with NTI. Further research in this area would be ideal, but NTIs remain potentially effective for patient support and education and can have a positive effect on patient experience.

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Chan, C. W., Richardson, A., & Richardson, J. (2011). Managing symptoms in patients with advanced lung cancer during radiotherapy: results of a psychoeducational randomized controlled trial. Journal of Pain and Symptom Management, 41, 347–357.

Study Purpose

To examine the effectiveness of a psychoeducational intervention (PEI) on the symptom cluster of anxiety, breathlessness, and fatigue compared with usual care.

Intervention Characteristics/Basic Study Process

Education on symptom management and coaching on the use of progressive muscle relaxation was delivered to patients one week prior to the start of radiotherapy (RT) and repeated three weeks after beginning RT. Symptom data were collected at four times points:  prior to the intervention and at three, six, and 12 weeks postintervention.

Sample Characteristics

  • In total, 140 patients (83% male, 17% female) with lung cancer receiving palliative RT were included.
  • Patients were 16 years or older.
  • Patients had stage III or IV lung cancer.

Setting

  • Single site
  • Outpatient
  • RT unit of a publicly funded hospital in Hong Kong

Study Design

The study was a randomized, controlled trial using a pre-/posttest design with two groups.

Measurement Instruments/Methods

  • Breathlessness was assessed using a 100-mm visual analog scale.
  • Fatigue was measured with the intensity subscale of the revised Piper Fatigue Scale (PFS), consisting of 23 items. The instrument was translated into Chinese and found to be valid and reliable.
  • Anxiety was measured using the Chinese version of the State-Trait Anxiety Inventory (STAI), consisting of 20 items for measuring immediate feelings of apprehension, nervousness, and worry.
  • Functional ability was a secondary outcome measure, using the subscale of the Chinese version of the Short Form 36 (SF-36) Health Survey.

Results

A significant difference (p = 0.003) was seen over time on the pattern of change of the symptom cluster between the PEI intervention and the usual care control group. Significant effects on patterns of changes in breathlessness (p = 0.002), fatigue (p = 0.011), anxiety (p = 0.001), and functional ability (p = 0.000) were found.

Conclusions

PEI is an effective treatment for relieving the symptom cluster of anxiety, breathlessness, and fatigue and each of the individually assessed symptoms.

Limitations

  • The study had a small sample size, with less than 100 participants.
  • A high attrition rate was due to death.

Nursing Implications

The study provided evidence to support the symptom cluster of anxiety, breathlessness, and fatigue as interrelated, with assessment and management of those three symptoms as a cluster. Clarification of the nature of their interrelatedness is a potential area of further study. Education and counseling patients through nurses can be helpful in the management of these symptoms.

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Chow, K.M., Chan, C.W., Chan, J.C., Choi, K.K., & Siu, K.Y. (2014). A feasibility study of a psychoeducational intervention program for gynecological cancer patients. European Journal of Oncology Nursing, 18, 385–392.

Study Purpose

To test the feasibility of the implementation of a psychoeducational intervention program for patients with gynecologic cancer

Intervention Characteristics/Basic Study Process

This study consisted of a series of interventions consisting of multiple components based on a thematic counseling model for patients with newly diagnosed gynecologic cancers. Blinding was performed at randomization. Quantitative data on sexual functioning, uncertainty, quality of life, anxiety, depression, and support systems were collected at recruitment, following surgery, during hospitalization, and eight weeks following surgery. Both quantitative and qualitative methods were used in the data analysis. The intervention consisted of four psychoeducational sessions. An individual format was used for the first three sessions and a group format was used for the last session. All intervention sessions were conducted by the researcher. The researcher also met with the control group on four occasions during the same period: at recruitment, after surgery, once in-hospital, and once via telephone four weeks following surgery during which participants were invited to attend a support group. The researcher was a registered nurse experienced in gynecologic cancer care.

Sample Characteristics

  • N = 26  
  • MEAN AGE = 54.5 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Cervical cancer, uterine cancer, and ovarian cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Preoperative for surgical resection of disease

Setting

  • SITE: Single-site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Hong Kong

Phase of Care and Clinical Applications

  • PHASE OF CARE: Diagnostic
  • APPLICATIONS: Elder care, palliative care 

Study Design

Single-blinded, randomized trial with a mixed-methods design

Measurement Instruments/Methods

  • Baseline data on outcome variables were measured at the initial intervention for both groups. Both groups were reassessed following surgery, during inpatient stay, and eight weeks after surgery. A Sexual Function-Vaginal Changes Questionnaire (SVQ) was given during the third interview. Interviews were recorded.
  • The Traditional Chinese Functional Assessment of Cancer Therapy–General (FACT-G) was used to measure quality of life. 
  • Mishel’s Uncertainty in Illness Scale (MUIS) was used to measure perceived uncertainty.
  • The Hospital Anxiety and Depression Scale (HADS) was used to assess anxiety and depression.
  • The Medical Outcomes Study Support Survey (MOS-SS) was used to measure perceived social supports.
  • Nonparametric inferential statistical methods were used in the analysis of quantitative data, including the Mann-Whitney U test and the Kruskal-Wallis test. Qualitative data were analyzed by content analysis based on transcriptions of the recordings.

Results

Thirteen patients were in the intervention group and 13 were in the control group. There were no statistical differences between the populations of the two groups. The compliance rate was 69.2% in the intervention group with the greatest lack of compliance occurring during the final session. The compliance rate for the control group was 46.2%. Statistic significance regarding trends of change in the outcome variables was not obtained. There was no statistic significance in the comparison of baseline outcome variables of the two groups. There was no statistic significance of intervention effects between the two groups, except in the area of uncertainty. The inconsistency subscale showed a statistic significance between the two groups with the intervention group receiving less inconsistent information regarding their illnesses. The intervention group demonstrated better trends for improvement than the control group in all categories although there were contradictory results in the scales measuring quality of life, perceived social support, anxiety, and depression.

Conclusions

This patient population has healthcare needs that currently are not being met. This particular study did not show statistically significant results regarding anxiety, depression, quality of life, and sexual functioning in patients with gynecologic cancer. Further research is indicated.

Limitations

  • Small sample (< 30)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results 
  • Findings not generalizable
  • Questionable protocol fidelity
  • Other limitations/explanation: Three interventions took place during a relatively short period of time, and one took place two months later. The implementation period was six months long.

Nursing Implications

Further research is indicated regarding anxiety, depression, quality of life, and sexual functioning in patients with gynecologic cancer, particularly during the postoperative period. This study showed trends for overall improvement, indicating the importance of nursing in this population. Understanding the implications of cultural differences regarding the effects of gynecologic therapies is an important nursing responsibility.

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Farquhar, M.C., Prevost, A.T., McCrone, P., Brafman-Price, B., Bentley, A., Higginson, I.J., . . . Booth, S. (2014). Is a specialist breathlessness service more effective and cost-effective for patients with advanced cancer and their carers than standard care? Findings of a mixed-method randomised controlled trial. BMC Medicine, 12, 194-014-0194-2. 

Study Purpose

To evaluate the effects of a specialized breathlessness intervention service compared to usual care

Intervention Characteristics/Basic Study Process

The breathlessness intervention service (BIS) was a multidisciplinary complex intervention including nonpharmacologic and pharmacologic interventions to support patients with advanced disease and dyspnea. The BIS used first-stage interventions such as positioning to reduce the work of breathing, education, individualized exercise plans, relaxation techniques, sleep hygiene, cognitive behavioral therapy approaches, and other supports. Second-stage interventions applied concurrently included opioids, antidepressants, anxiolytics, etc. Patients referred to this service were randomly assigned to the intervention or to a wait-list control group. Study measures were obtained at baseline and after the intervention. Interviews were done before randomization, at two weeks, and at five weeks. The interviews were recorded and transcribed verbatim for analysis. A final qualitative analysis was done from 20 intervention transcripts that were purposefully sampled to obtain a diverse group from those who improved and did not improve.

Sample Characteristics

  • N = 54 (47 completed five-week evaluations, 39 respondents)
  • MEAN AGE = 69 years (SD = 11.5 years)
  • MALES: 59%, FEMALES: 41%
  • KEY DISEASE CHARACTERISTICS: Lung cancer was most prevalent

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified    
  • LOCATION: United Kingdom

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Palliative care 

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Distress scores caused by breathlessness
  • Hospital Anxiety and Depression Scale (HADS)
  • Chronic Respiratory Questionnaire (CRQ)
  • Numeric Rating Scale (NRS) for distress
  • EuroQol Five Dimensions Questionnaire (EQ 5-D) for generic health status

Results

Patients in the intervention group had greater reductions in breathlessness (1.68 versus 0.23 points, p = 0.049). There were no other significant differences in outcomes for patients or caregivers between study groups. Interventions identified as helpful were providing and teaching the use of a handheld fan, encouraging exercise, coaching in breathing techniques and positioning, medication changes, and referrals to other services. Total costs were lower for the intervention group, and a cost effectiveness analysis showed a 66.4% likelihood that the intervention would result in lower cost and better outcomes in terms of reduced distress from breathlessness. Scores for mastery of symptom management did not change significantly.

Conclusions

This complex psychoeducational and pharmacologic intervention was associated with reduced distress from breathlessness. No effects on patient or caregiver distress, anxiety, or depression were found.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: With this complex, multicomponent intervention, it was not possible to determine which aspects were most effective in achieving improved outcomes.

Nursing Implications

Individual interventions such as opioid use have been shown to reduce dyspnea, so it was not possible to determine the relative value and utility of the combined interventions examined here. These study findings suggested that multicomponent, complex interventions to improve symptoms of breathlessness can be cost effective and improve outcomes.

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Fernandez-Feito, A., Lana, A., Baldonedo-Cernuda, R., & Mosteiro-Diaz, M.P. (2015). A brief nursing intervention reduces anxiety before breast cancer screening mammography. Psicothema, 27, 128–133. 

Study Purpose

To determine if a brief nursing intervention could reduce anxiety prior to screening mammography

Intervention Characteristics/Basic Study Process

Women received an intervention protocol consisting of face to face general information about screening as well as emotional support by discussing other topics related to the examination and anxiety. The intervention took about 10 minutes. Anxiety was assessed before the mammography. Anxiety also was assessed among women receiving usual care. The results from both groups were compared.

Sample Characteristics

  • N = 436
  • AGE RANGE = 50–69 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All were receiving screening mammography
  • OTHER KEY SAMPLE CHARACTERISTICS: 63% had family history of cancer; none had pathology at the time of the study

Setting

  • SITE: Single site
  • SETTING TYPE: Outpatient  
  • LOCATION: Spain

Phase of Care and Clinical Applications

  • PHASE OF CARE: Diagnostic

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Speilberger Strait-Trait Anxiety Inventory (STAI) 

Results

Women in the experimental group had a significantly lower mean state anxiety score (p < 0.001) and a 60% likelihood of having lower anxiety (OR -0.40, 95% CI 0.25, 0.65). There were no differences between the groups in trait anxiety or expectations of pain from the procedure.

Conclusions

A brief psychoeducational intervention prior to a screening mammography appears to be effective in reducing anxiety associated with the screening mammography.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Key sample group differences that could influence results
  • Other limitations/explanation: More patients in the experimental group were receiving antianxiety or antidepressant medications, approaching a statistically significant amount (p = 0.07). Randomization was not described. There was no baseline anxiety scoring, so it is not known if women in the experimental group had lower anxiety to begin with rather than as a result of the intervention.

Nursing Implications

A brief psychoeducational intervention providing information about mammography and breast cancer and giving women the opportunity to express anxiety concerns was associated with lower anxiety. In this study, the intervention took only 10 minutes, suggesting that it could be a practical approach to care. By spending a little time educating women and providing them the opportunity to express concerns, nurses can help reduce the anxiety that may be associated with screening mammographies.

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Garssen, B., Boomsma, M.F., Jager Meezenbroek, E., Porsild, T., Berkhof, J., Berbee, M., . . . Beelen, R.H. (2013). Stress management training for breast cancer surgery patients. Psycho‐Oncology, 22, 572–580.

Study Purpose

To evaluate the psychological effects of presurgical stress management training

Intervention Characteristics/Basic Study Process

Subjects were randomized to the intervention or control group by week in the hospital. The intervention consisted of four sessions of meditative exercises, relaxation, guided imagery, and counseling to promote active coping and positive attitude. Sessions were completed on days 5 and 1 before surgery and days 2 and 30 postsurgery. Patients were given a CD with the same instructions to use at home. Assessments were done on days 6 and 1 before surgery and days 2, 5, 30, and 90 postsurgery. The control group received usual care.

Sample Characteristics

  • N = 70
  • MEAN AGE = 52 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer; all stages undergoing surgery; most had lumpectomy

Setting

  • SITE: Single-site
  • SETTING TYPE: Multiple settings
  • LOCATION: Netherlands

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ C30)
  • Profile of Mood States (POMS) scale for fatigue and depression
  • Subjective sleep quality scale
  • Numeric Pain Rating Scale (NRS)

Results

Anxiety decreased after surgery in both groups. Depression decreased in the intervention group after surgery and in the control group at three months postsurgery. Depression was significantly lower in the intervention group on day 5 after surgery (d = 0.47). Fatigue increased in the control group and was significantly higher than baseline at three months postoperatively. In the intervention group, fatigue decreased and was significantly below baseline at days 2 and 5 postoperatively. Sleep problems and pain did not change in either group. Across all study timepoints, differences between groups were inconsistent. Sometimes, symptoms were higher in the intervention group, and other times, they were lower in the intervention group. An analysis was done for changes from baseline for each group rather than between groups. There were only differences in the degree of change from baseline to postoperative days 2 and 5.

Conclusions

The effects of the intervention were inconsistent over time and appeared to be modest and short-lasting.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Unintended interventions or applicable interventions not described that would influence results
  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable
  • Other limitations/explanation: Though small, the power analysis showed that the sample was sufficient to detect moderate effects. Baseline depression and fatigue levels were much higher in the intervention group, suggesting floor effects in the control patients. Six repeated measures could produce testing effects. There was no information about how often patients used the CDs at home. No information regarding other known intervention variables, including any adjuvant treatment during the study period, was provided.

Nursing Implications

The findings here were somewhat confusing and inconsistent over time; however, there were some potential short-term benefits for fatigue and depression. The combination of relaxation therapies and counseling is a low-risk intervention that may be helpful for some patients.

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Goerling, U., Foerg, A., Sander, S., Schramm, N., & Schlag, P.M. (2011). The impact of short-term psycho-oncological interventions on the psychological outcome of cancer patients of a surgical-oncology department—A randomised controlled study. European Journal of Cancer, 47, 2009–2014.

Study Purpose

To examine the influence of psycho-oncologic intervention on the psychological condition of patients with cancer

Intervention Characteristics/Basic Study Process

Patients, who had self-assessed regarding anxiety and depression levels, were placed in high- or low-risk groups. Participants were then randomized to either a psycho-oncologic support group or a control group. Support involved talks with a certified psychologist, who addressed development of a therapeutic relationship, supported the patient’s personal autonomy and defense mechanisms, worked to increase hopefulness and confidence, and facilitated communication between patients and providers. Patients were randomized at the time of surgery. Study measures were obtained at hospital discharge and 12 months later. The number of support sessions varied according to the length of inpatient care. High-risk groups averaged four sessions lasting an average of 41 minutes each. Low-risk patients had two or three sessions lasting an average of 40 minutes each.

Sample Characteristics

  • The sample was composed of 131 participants.
  • Mean patient age was 57.2 years, with a range of 27–79 years.
  • The sample was 36.6% male and 63.4% female.
  • All cancer types were represented.

Setting

  • Single site
  • Inpatient setting
  • Berlin, Germany

Phase of Care and Clinical Applications

Active treatment

Study Design

Randomized controlled trial

Measurement Instruments/Methods

Hospital Anxiety and Depression Scale (HADS), German version

Results

The study showed statistically significant reduction of anxiety and depression in high-risk patients who had undergone psycho-oncologic intervention at the end of inpatient care (p = 0.001). At 12 months, anxiety and depression scores increased in all patients. Depression scores increased in all low-risk patients at the time of discharge.

Conclusions

Patients with cancer who have anxiety may benefit from psycho-oncologic support.

Limitations

  • The study sample had a higher percentage of women than men, and patients had different cancer diagnoses.
  • At 12 months, only 49 patients had completed the HADS tool.

Nursing Implications

Postsurgical patients with cancer who are anxious may benefit from psycho-oncologic support services. In the study, the effect of the intervention was significant in only those patients who had high anxiety scores at baseline. Study findings are similar to those produced by other research. This fact may suggest that interventions for anxiety are most beneficial for individuals who have meaningful levels of anxiety to begin with. Psycho-oncologic support did not appear to affect depression scores; however, these scores were not high at baseline.

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Halkett, G.K., O'Connor, M., Aranda, S., Jefford, M., Shaw, T., York, D., . . . Schofield, P. (2013). Pilot randomised controlled trial of a radiation therapist-led educational intervention for breast cancer patients prior to commencing radiotherapy. Supportive Care in Cancer, 21, 1725–1733. 

Study Purpose

To determine whether a therapist-led psychoeducational intervention is effective in reducing anxiety, depression, and radiation therapy-related patient concerns

Intervention Characteristics/Basic Study Process

Patients in the control group received usual care. The intervention group received two face-to-face therapist consultations, one prior to radiation planning and one prior to treatment. Therapists received training in how to prepare patients for radiotherapy planning and treatment, focusing on procedure and sensory and side effect information, as well as training in eliciting and responding to emotional cues. Study measures were obtained at baseline and after each intervention time point. Intervention delivery was recorded, and content analysis was completed to determine intervention fidelity by two reviewers from a randomly selected set of 40 recorded sessions.

Sample Characteristics

  • N = 102
  • MEAN AGE = 54.6 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All participants were diagnosed with breast cancer and were receiving radiation therapy. About 73% of participants were receiving concomitant chemotherapy.
  • OTHER KEY SAMPLE CHARACTERISTICS: Slightly greater than half of participants were employed part- or full-time, 25% had some college-level education, and one third had less than 10 years of formal education. The majority of participants were married.

Setting

  • SITE: Single-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Australia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • Concerns about radiotherapy scale (reliability = .91)
  • Knowledge of radiotherapy scale (reliability = .86)
  • Patient preparedness and understanding index: Single-item Visual Analog Scale (VAS) 

Results

Analysis showed statistically significant intervention effects for anxiety after the first intervention, (p = .0009) but a small size of effect (beta coefficient = –.145). There was no significant effect seen after the second intervention session. There was no effect on depression scores. Knowledge scores increased more on average for the intervention group between baseline and the first intervention session (p < .05) and related concerns dropped more in the intervention group over the same time period (p < .01).

Conclusions

The provision of a psychoeducational intervention was effective in increasing patients’ knowledge, reducing radiation therapy-related concerns, and reducing anxiety in women receiving radiation therapy for breast cancer.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: Baseline HADS scores were not provided, so it is not clear whether any patients had clinically-relevant anxiety or depression or if there was a floor effect in measurement.  Usual care was not well-described, so it is not clear how much or what type of information usual care patients received.

Nursing Implications

The provision of this type of education and supportive intervention may reduce anxiety and improve patient knowledge prior to beginning radiation therapy.

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Hirai, K., Motooka, H., Ito, N., Wada, N., Yoshizaki, A., Shiozaki, M., . . . Akechi, T. (2012). Problem-solving therapy for psychological distress in Japanese early-stage breast cancer patients. Japanese Journal of Clinical Oncology, 42, 1168–1174.

Study Purpose

To examine the feasibility and effectiveness of problem-solving therapy for psychological distress among patients with early-stage breast cancer

Intervention Characteristics/Basic Study Process

The problem-solving therapy involved five weekly sessions aimed at assessing problems, setting goals, generating solutions, choosing a solution, and implementing the solution and evaluating results. The therapy included a manual and worksheet for patients to use. Authors collected self-report data prior to the intervention, after the final sessions, and three months after the final sessions.

Sample Characteristics

  • Mean patient age was 50.21 years (SD = 11.09 years).
  • The sample was 100% female.
  • The majority of participants had stage II disease. All had had prior surgery; 89% were on hormone therapy.
  • Of all participants, 43% were employed full- or part-time, 79% were married, and 21% had a college education.

Setting

  • Single site
  • Outpatient setting
  • Japan

Phase of Care and Clinical Applications

Patients were undergoing active antitumor treatment.

Study Design

A pre/post-test design was used.

Measurement Instruments/Methods

  • Two-item 11-point Likert-type distress scale
  • Hospital Anxiety and Depression Scale (HADS), Japanese version
  • Scale that measured self-efficacy of patients with advanced cancer
  • Brief Cancer-Related Worry Inventory
  • European Organization for Research and Treatment Cancer Core Quality-of-Life Questionnaire (QLC-C30), Japanese version

Results

Four patients dropped out of the study after starting treatment. Analysis showed a significant effect of time on anxiety and depression scores (p < 0.01).  Over time scores for global health status, physical functioning, emotional functioning, and role functioning improved significantly.

Conclusions

The study shows that symptoms of anxiety and depression and some aspects of quality of life improved over time. The effect of the intervention cannot be evaluated from these study results. Though authors state that the intervention was feasible, the fact that 17% of the initial sample did not complete the study suggests that the intervention was not of interest to a substantial proportion of the patients.

Limitations

  • The study had a small sample size, with fewer than 30 participants.
  • The study had risks of bias due to the lack of a control group, blinding, and random assignment.

Nursing Implications

Study results are insufficient to allow evaluation of the acceptability and efficacy of the problem-solving intervention.

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Jones, R.B., Pearson, J., Cawset, A.J., Bental, D., Barrett, A., White, J., . . . Gilmour, W.H. (2006). Effect of different forms of information produced for cancer patients on their use of the information, social support, and anxiety: Randomised trial. BMJ, 332, 942–948.

Intervention Characteristics/Basic Study Process

The interventions included a variety of patient education materials delivered by the following methods.

  • General cancer education material (Cancer BACUP, a cancer information and support service for patients in the United Kingdom) specific to the patient's cancer—This material included content about understanding radiation therapy, diet, and cancer-specific information.
  • Patient-chosen information selected interactively via computer at the cancer center—The patient was given a choice of six booklets to print from the computer.
  • A larger volume of material than in the booklets, not chosen specifically by the patient—This information included 40–47 sections of information.
  • Patient-chosen personalized information selected interactively from topics based on the patient’s medical record—These topics included “problem list, treatment lists, or your cancer.”
  • A subgroup of participants received anxiety management advice. This information was provided through written materials with self-help advice based on work in cognitive behavioral therapy for anxiety.

Participants were divided into eight groups (three factors, 2 x 2 x 2).

  • Group 1: Interactively selected, personalized information, and anxiety management advice (N = 50, t2 N = 48, t3 N = 40)
  • Group 2: Interactively selected, personalized information, and no anxiety management advice (N = 50, t2 N = 48, t3 N = 44)
  • Group 3: Interactively selected, general information, and anxiety management advice (N = 49, t2 N = 44, t3 N = 35)
  • Group 4: Interactively selected, general information, and no anxiety management advice (N = 50, t2 N = 50, t3 N = 49)
  • Group 5: Automatically selected, personalized information, and anxiety management advice (N = 50, t2 N = 47, t3 N = 39)
  • Group 6: Automatically selected, personalized information, and no anxiety management advice (N = 51, t2 N = 50, t3 N = 44)
  • Group 7: Automatically selected, general information, and anxiety management advice (N = 50, t2 N = 49, t3 N = 40)
  • Group 8: Automatically selected, general information, and no anxiety management advice (N = 50, t2 N = 48, t3 N = 38)

Measurements were taken at baseline, after intervention, and at three months follow-up.

Sample Characteristics

  • Study participants were patients starting radiation therapy.
  • A total of 874 patients with cancer were identified through radiation clinic appointments. Of these, 604 patients were recruited to the study, and 270 were excluded.
  • Patients were excluded if they were receiving palliative care, had severe symptoms causing distress, had cancer at other sites, did not have English-language skills, were receiving treatment for psychological or psychiatric problems, or were visually or mentally impaired.
  • The study reported on a sample of 400 patients with cancer diagnosed from 5 weeks to six years before recruitment.
  • Patients completed a questionnaire at home about their previous computer use, information preferences, coping styles, and HSSQ and HADS tests.
  • Two-thirds of the patients had breast cancer, and roughly one-third had prostate cancer.
  • A total of 348 patients finished follow-up.

Setting

Western Scotland

Study Design

A longitudinal, randomized trial design was used.

Measurement Instruments/Methods

  • Helgeson’s Social Support Questionnaire (HSSQ)
  • Hospital Anxiety and Depression Scale (HADS)
  • Questions about the patients’ use and opinions of the booklets and their reported understanding of cancer

Results

At three months follow-up, 45% of patients had improved anxiety scores. There were no statistically significant differences among the three intervention factors using a general linear model.

Conclusions

  • The authors concluded that the single information intervention with anxiety management advice in this study did not significantly reduce levels of anxiety.
  • This large study showed that brief written anxiety advice does not significantly reduce anxiety in patients with cancer who are starting radiation therapy.
Print

Kashani, F., Kashani, P., Moghimian, M., & Shakour, M. (2015). Effect of stress inoculation training on the levels of stress, anxiety, and depression in cancer patients. Iranian Journal of Nursing and Midwifery Research, 20, 359–364.

Study Purpose

To investigate the effects of inoculation training on stress, anxiety, and depression

Intervention Characteristics/Basic Study Process

Forty patients were randomly selected and randomly assigned to study and control groups. Study group patients had weekly group education sessions for eight weeks. Sessions were aimed at understanding stress, relaxation, education, concepts of cognition, feelings and behaviors, role of negative self-talk, concentration and distraction techniques, and problem solving skills. Data were obtained before and after the intervention period.

Sample Characteristics

  • N = 40  
  • AGE RANGE: 28-65 years
  • MALES: 31.73%,FEMALES: 68.27%
  • KEY DISEASE CHARACTERISTICS: Patients had non-hematologic cancers and were in the third course of chemotherapy. None were receiving radiation therapy.

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified    
  • LOCATION: Iran

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • Depression Anxiety and Stress Scale (DASS)

Results

Anxiety and depression declined after the intervention, but did not decline in the control group. After eight weeks, anxiety was significantly lower in the intervention group (p = 0.00) and depression was significantly lower than controls (p = 0.04). Stress increased in the control group, but declined in the intervention group (p = 0.01).

Conclusions

The psychoeducational intervention tested here was associated with significantly less anxiety and depression compared to patients who did not receive this intervention.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement/methods not well described
  • Other limitations/explanation: No information is provided about the types of cancer, stage of disease, type of chemotherapy provided, other associated symptoms, or use of medication that may affect anxiety or depression–all of which could be expected to influence outcomes. The specific timing of postintervention measurement is not stated.

Nursing Implications

Findings suggest that the type of psychoeducational intervention provided here was helpful to manage anxiety and depression. Study design limitations affect the strength of evidence from this particular study; however, findings are in general concert with the body of evidence regarding effectiveness of psychoeducational interventions. Various psychoeducational interventions have been shown to be effective for anxiety and depression. These interventions can be incorporated into usual nursing practice.

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Katz, M.R., Irish, J.C., & Devins, G.M. (2004). Development and pilot testing of a psychoeducational intervention for oral cancer patients. Psycho-Oncology, 13, 642–653.

Intervention Characteristics/Basic Study Process

The intervention involved a 95-page teaching booklet, What to Expect From Your Oral Cancer Surgery: A Guide for Patients and Families. The booklet included information about oral cancer, treatments, and effective coping strategies. Contents were divided into preparing for surgery, postoperative care, and returning home.

In the intervention group, the booklet was given to patients pre- and postoperatively by a nurse experienced in caring for patients with head and neck cancers. The preop session was 60–90 minutes of individual teaching before admission to the hospital for surgery. The predischarge session was 60–90 minutes of individual teaching several days prior to expected discharge from the hospital.

In the control group, patients received standard level of care, which included a preop meeting with the surgeon for consent to treatment as well as a brief description of the illness and treatment. Also included in the preadmission information was a tour of the ward and a team visit from the physician, dietitian, social worker, speech therapist, and enterostomal nurse. No information about coping or emotional difficulties was provided routinely. Measurements were taken at baseline, predischarge, and three months follow-up.

Sample Characteristics

  • The sample was comprised of 19 patients newly diagnosed with head and neck cancer who were scheduled for their first surgery.
  • The intervention group had 10 patients, and the control (standard care) group had 9 patients.

Setting

  • Hospital setting
  • Toronto, Ontario, Canada

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Demographic/disease history tool
  • Observer-Rated Disfigurement Scale
  • Short Michigan Alcoholism Screening Test (SMAST-13): Used to measure history of alcoholism
  • Medical Outcomes Study (MOS) Social Support Survey
  • Recent stressful life events checklist for chronically ill populations
  • Knowledge questionnaire to measure oral cancer–related knowledge
  • Stanford Inventory for Cancer Patient Adjustment (SICPA): Used to measure self-efficacy
  • State-Trait Anxiety Inventory (STAI)
  • Center for Epidemiologic Studies–Depression scale
  • Affect Balance Scale: Used to measure quality of life (QOL)
  • Body Image Scale
  • Atkinson Life Happiness Rating Scale: Used to measure QOL in medically ill populations
  • Illness Intrusiveness Ratings Scale
  • EORTC QOL questionnaire: Five-item patient satisfaction survey
  • Analysis of stats: Simple ANOVA (group x time interaction)

Results

The authors reported significant improvement in anxiety scores within the intervention group from time 1 to time 3 (t = 2.88, df = 9, p = 0.018).

Limitations

  • The study had a small sample size.
  • The intervention was a booklet created by a psychiatrist, head and neck surgeon, health psychologist, head and neck dietitian, head and neck speech-language pathologist, nurse educator, and medical illustrator, with patient focus groups as reviewers. This would be costly to replicate.
  • An RN spent 60–90 minutes with each patient/family to teach, both preop and predischarge.
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Kim, H.S., Shin, S.J., Kim, S.C., An, S., Rha, S.Y., Ahn, J.B., . . . Lee, S. (2013). Randomized controlled trial of standardized education and telemonitoring for pain in outpatients with advanced solid tumors. Supportive Care in Cancer, 21, 1751–1759.

Study Purpose

To evaluate whether standardized educational tools, with or without telemonitoring, can improve the pain levels, pain interference, anxiety, depression, distress, performance, and quality of life of outpatients with cancer who have advanced tumors

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either standard pain education plus telemonitoring or standard education alone. A nurse practitioner (NP) performed telemonitoring of pain every day for one week. The NP telephoned the patients and asked for average visual analog scale (VAS) pain score and worst VAS pain score in the last 24 hours. This provided patients with the opportunity to assess the severity of pain themselves. Using the National Comprehensive Cancer Care Network (NCCN) guidelines for pain management, the NP advised patients whether to increase or decrease medication. The NP was trained in pain management but had no specific training for other psychosocial interventions. Standard education included a video and booklet with individual coaching, to correct misconceptions, and an outline of decision making for pain control. Outcomes were measured at one week, and average pain was measured at two months.

Sample Characteristics

  • The study reported on a sample of 108 patients.
  • Mean patient age was 59.8 years.
  • The sample was 67.6% male and 32.4% female.
  • The sample included patients with stage IV solid tumors (breast, gastrointestinal, genitourinary, lung, head and neck, and other).
  • Most patients had been prescribed opioid analgesics.

Setting

  • Single site
  • Outpatient
  • Seoul, Republic of Korea

Phase of Care and Clinical Applications

  • Patients were undergoing the end-of-life phase of care.
  • The study has clinical applicability for elder care and palliative care.

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Brief Pain Inventory (BPI)
  • Hospital Anxiety and Depression Scale (HADS)
  • Distress Thermometer
  • European Organization for Research and Treatment of Cancer quality of life questionnaire
  • Karnofsky Performance Status score

Results

Pain intensity, for all patients, had significantly improved at one week, including worst pain (7.3–5.7, p < 0.01) and average pain (4.6–3.8, p < 0.01). Additionally, anxiety (HADS score ≥ 11, 75%–56%, p < 0.01), depression (HADS score ≥ 11, 73%–51%, p < 0.01), quality of life (fatigue and insomnia), and Karnofsky score (32–66, p < 0.01) were significantly improved at one week. However, the level of distress did not improve. The study revealed no significant differences between groups in these areas.

Conclusions

Standardized pain education delivered by a nursing specialist is an efficient means of improving not only pain but also anxiety, depression, performance, and quality of life. This study did not show that the addition of telemonitoring substantially improved pain management in the outpatient setting.

Limitations

  • The study had risk of bias due to the lack of an appropriate attentional control condition.
  • A one-week study may be too short to show significant improvement in pain outcomes.
  • To extend this study, researchers should conduct a baseline screening with multiple variable assessments in addition to the Karnofsky score.

Nursing Implications

Findings show that comprehensive pain education was associated with short-term reduction in pain, anxiety, and depression scores. The addition of telemonitoring follow-up for pain management did not result in a significant difference in these scores; however, the follow-up period  was only one week. Longer-term studies of the effects of monitoring via telephone and other technologies, for the purpose of improved symptom management, may be helpful in identifying effective methods of improving symptom control in outpatient settings.

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Krischer, M.M., Xu, P., Meade, C.D., & Jacobsen, P.B. (2007). Self-administered stress management training in patients undergoing radiotherapy. Journal of Clinical Oncology, 25, 4657–4662.

Intervention Characteristics/Basic Study Process

The intervention was a self-administered stress management training (SSMT) program for patients treated with radiation therapy. The usual care only (UCO) intervention included the usual psychosocial care typically provided at the institution where patients were receiving treatment. Participants in the SSMT program met individually with a nurse for approximately five minutes to receive instructional materials and explanations. The instructional materials consisted of a 15-minute prerecorded videotape, a 12-page booklet, and a 35-minute prerecorded audiotape titled “Active Relaxation,” which taught paced breathing, active relaxation, and positive thinking with guided imagery instructions. Data were collected at baseline and weeks 1, 2, and 3.

Sample Characteristics

  • The study reported on a sample of 310 patients prior to starting treatment with radiation.
  • The UCO group had 156 patients, and the SSMT group had 154 patients.

Setting

Multiple centers in South Florida

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Mental Component Summary score of the Medical Outcomes Study–short form (SF-36)
  • Center for Epidemiologic Studies–Depression Scale (CES-D)
  • State-Trait Anxiety Inventory (STAI)–state anxiety
  • Statistical analyses repeated measures using SAS PROC MIXED based on unstructured covariance matrix model assumption
  • The models used for analysis included the baseline measures as covariates: the effects of treatment alone, time alone, the interaction of treatment with time, the quadratic effect of time, and the quadratic effect of treatment and time.

Conclusions

SSMT is effective only in those patients receiving radiotherapy with initially higher levels of psychological distress at baseline.

Limitations

Special training needs include the creation of the SSMT tool (instructional materials, video tables, and audiotapes).

Nursing Implications

Intervention requires screening for psychological distress.

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Lee, J.Y., Park, H.Y., Jung, D., Moon, M., Keam, B., & Hahm, B.J. (2014). Effect of brief psychoeducation using a tablet PC on distress and quality of life in cancer patients undergoing chemotherapy: A pilot study. Psycho‐Oncology, 23, 928–935. 

Study Purpose

To examine the benefits of a single-session psychoeducational intervention using a tablet PC during chemotherapy

Intervention Characteristics/Basic Study Process

Patients were assigned to intervention or control groups according to their dates of informed consent rather than strict randomization. Study measures were obtained at baseline and two to four weeks later. The study group was given a single-session psychoeducational intervention using a tablet PC to administer the education.

Sample Characteristics

  • N = 19 (intervention), 17 (control)  
  • AVERAGE AGE = 57.5 years
  • MALES: 45%, FEMALES: 55%
  • KEY DISEASE CHARACTERISTICS: Patients with cancer undergoing chemotherapy
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority of participants were married and were diagnosed with stage IV cancer with an Eastern Cooperative Oncology Group score of 1. All participants scored 11 or more on anxiety and depression scales.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Seoul, South Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care, palliative care 

Study Design

Two-group trial

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • Short Form-8 Health Survey (SF-8)
  • Insomnia Severity Index (ISI)
  • Impact of Event Scale–Revised (IES-R)

Results

Compared to the control group, the intervention group showed a positive score change on the HADS scale. The mental component summary score of the SF-8, the IES-R avoidance subscale, the ISI, and the total score of the HADS scale were the following. HADS (p = .0002), SF-8 (p = .011), ISI (p = .021), and IES-R (p = .036) declined from baseline more in the intervention group. Scores did decline in both groups.

Conclusions

A tablet-based, 20-minute psychoeducational intervention could be an effective intervention for managing depression, sleep disturbance, and quality of life.

Limitations

  • Small sample (< 100) 
  • Risk of bias (no random assignment)
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation: Patients needed to understand how to use a tablet PC. Patients had to be able to hear and understand the tablet PC. Patients had to be undergoing chemotherapy. Tablet PCs are expensive. There was a high refusal rate to participate in the study.

Nursing Implications

This was not a well-made study and had low numbers. Feasibly, nurses could hand their patients a tablet and not interact with them.
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Liao, M.N., Chen, S.C., Lin, Y.C., Chen, M.F., Wang, C.H., & Jane, S.W. (2014). Education and psychological support meet the supportive care needs of Taiwanese women three months after surgery for newly diagnosed breast cancer: A non-randomised quasi-experimental study. International Journal of Nursing Studies, 51, 390–399. 

Study Purpose

To investigate the effects of education and psychological support on anxiety, symptom distress, social support, and unmet supportive care needs of Taiwanese women newly diagnosed with breast cancer over three months following surgery

Intervention Characteristics/Basic Study Process

Education and psychological support was provided in the form of three individual face-to-face sessions and two telephone follow-up sessions. A standardized educational booklet was used. Sessions were done at the first postoperative visit, the first chemotherapy session, and three months after surgery. The telephone follow-up call was made seven days before chemotherapy and two months after surgery. Study measures were obtained at baseline, one month after surgery, and three months after surgery.

Sample Characteristics

  • N = 40 (experimental), 40 (control) 
  • AVERAGE AGE = 50.7 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer, postsurgical intervention
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority of participants were married or living with a partner, had a higher educational level and family income, had a mastectomy versus a lumpectomy, and were undergoing chemotherapy.

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Taiwan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care, palliative care 

Study Design

Two-group, nonrandomized, quasiexperimental study

Measurement Instruments/Methods

All forms were in Chinese.

  • State-Trait Anxiety Inventory (STAI) to measure anxiety
  • Symptom Distress Scale (SDS) modified for breast cancer
  • Modified Social Support Scale (SSS)
  • Supportive Care Needs Survey–Short Form (SCNS-SF)

Results

The experimental group experienced lower levels of overall unmet supportive care needs and had lower levels of unmet needs in other dimensions as well. Levels of state anxiety and symptom distress also were lower in this group. Primary concerns across groups were self-care and supportive care. Anxiety declined in both groups at similar levels by the first follow-up measure. By three months after surgery, there was a greater reduction in anxiety scores in the experimental group, which were significantly lower than those of the control group (p < .001).

Conclusions

The educational and psychological support components of the intervention improved the unmet supportive care needs of patients newly diagnosed with breast cancer three months after surgery.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results 
  • Key sample group differences that could influence results
  • Other limitations/explanation: Patients were overwhelmingly married or had a partner, had a higher income, and had higher levels social support. The experimental group had significantly lower baseline state anxiety scores and significantly lower levels of unmet needs at baseline. No information was provided regarding the number of patients included in follow-up data collection; this is not reflected in the consort diagram. Usual care is not described. There is no discussion of any medication or other interventions that could have affected outcomes observed.

Nursing Implications

Assessing patient concerns regarding social support at baseline and providing education that reflects those concerns can be an effective way to meet patient needs. Nurses can perform this assessment and education. This type of support can be economically and effectively provided, and this intervention can be done over the telephone.
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Lindemalm, C., Mozaffari, F., Choudhury, A., Granstam-Björneklett, H., Lekander, M., Nilsson, B., . . . Mellstedt, H. (2008). Immune response, depression and fatigue in relation to support intervention in mammary cancer patients. Supportive Care in Cancer, 16, 57–65.

Study Purpose

To examine the effect of a support intervention on immune function and levels of depression, anxiety, and fatigue in patients with breast cancer after completion of surgery and adjuvant treatment

Intervention Characteristics/Basic Study Process

A total of 41 women were chosen from an ongoing prospective randomized study. The first patients in each stratum of treatment were chosen for current study. Twenty-one women received adjuvant combined radio-chemotherapy (CT-RT), and 20 women received radiotherapy (RT). Eleven CT-RT patients and 10 RT patients were randomized to the support group, while 10 CT-RT and 10 RT patients served as controls. The support intervention consisted of educational lectures about cancer etiology, risk factors, treatment, psychological and physical effects, and coping. Exercise, relaxation training, qigong, and art therapy were also included. The intervention was provided for one week and then for another four days two months later. Study measures were obtained at baseline, 2 months, 6 months, and 12 months.

Sample Characteristics

  • The study reported on a sample of 41 patients with breast cancer (100% female).
  • Patient age range was 56–69 years.
  • Most patients were receiving chemotherapy and radiation therapy.

Setting

  • Single site
  • Outpatient setting
  • Vasteras Hospital, Sweden

Phase of Care and Clinical Applications

Patients were in the transition phase after initial treatment.

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale    
  • Norwegian Fatigue Questionnaire
  • Immune Analysis

Results

There was no significant immune effect from the support intervention. More patients in the support group had higher anxiety scores at the start of the intervention compared to the nonsupport group. The mean value anxiety score in the support group was also higher compared to the nonsupport group and improved significantly over time. Low levels of depression were reported in both groups, with no significant difference in depression scores. There was no significant difference in fatigue, but fatigue significantly improved over time in all patients. There were no significant differences in study measures between groups.

Conclusions

The support intervention had no effect on depression or immune parameters. There was no difference in improvement of anxiety and fatigue over time associated with the intervention.

Limitations

  • The study had a small sample, with less than 100 participants.
  • The sample had low depression scores at baseline.
  • It is not clear how the intervention was provided, whether individually, in groups, in the home, or in some other setting. 
  • The study had no blinding.

Nursing Implications

Findings do not support effectiveness of the intervention tested here. Results show that depression, anxiety, and fatigue improved significantly over time.

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Liu, C.J., Hsiung, P.C., Chang, K.J., Liu, Y.F., Wang, K.C., Hsiao, F.H., . . . Chan, C.L. (2008). A study on the efficacy of body–mind–spirit group therapy for patients with breast cancer. Journal of Clinical Nursing, 17, 2539–2549.

Study Purpose

To examine the effects of body–mind–spirit group therapy on anxiety, depression, and well-being in women with breast cancer

Intervention Characteristics/Basic Study Process

The intervention was 10 group sessions based on positive psychology and forgiveness therapy to enhance physical strength, increase emotional release, and develop positive meaning of life. Specific exercises included things such as self-care planning, massage of acupuncture points, drawing, creating love cards for others, and sharing strategies.

Sample Characteristics

  • The study reported on a sample of 28 female patients with breast cancer.
  • Most patients had stage II disease and had undergone modified radical mastectomy.
  • Of the sample, 61% were married and identified as “religious,” 63% were employed, and 55% had high school or higher level of education.

Setting

  • Single site
  • Outpatient setting
  • Taiwan

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

A mixed-methods study design was used: randomized controlled trial with focus group interview.

Measurement Instruments/Methods

  • Beck Depression Inventory, second edition (BDI-II)
  • State-Trait Anxiety Inventory (STAI)
  • Body–Mind–Spirit Well-being Inventory (BMSWBI): 10-point scale with 56 items (alpha = 0.87–0.92)
  • Qualitative analysis of verbatim transcripts of focus group interview. Interview guide used open-ended questions structured according to a published set of suggested questions.

Results

There was no difference over time for depression or well-being. The intervention group had a greater reduction in anxiety (p = 0.03) compared to the control group, with an effect size estimate of 0.56, suggesting a medium clinical significance. Qualitative analysis demonstrated that reduced anxiety was facilitated through a group process.

Conclusions

Results of focus group interviews demonstrated that these effects were facilitated through a group process. There were no apparent effects of the intervention on depression or well-being.

Limitations

  • The study had a small sample size.
  • Attrition was a problem, with a 35% drop-out rate, more in the experimental group than the control group.

Nursing Implications

Qualitative results suggest that the main effects of the intervention were associated with provision of information and the peer group interactions. It is not clear if the philosophic foundations and exercises used in the interventions were essential to these effects.

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Mahendran, R., Lim, H.A., Tan, J.Y., Chua, J., Lim, S.E., Ang, E.N., & Kua, E.H. (2015). Efficacy of a brief nurse-led pilot psychosocial intervention for newly diagnosed Asian cancer patients. Supportive Care in Cancer, 23, 2203–2206.

Study Purpose

To determine if psychosocial interventions, led by nurses instead of mental health professionals, for patients newly diagnosed with cancer in Singapore could help ease distress, minor psychiatric morbidity, and psychosocial worry

Intervention Characteristics/Basic Study Process

This quasiexperimental study researched the benefits of a six-month nurse-led psychosocial intervention program for patients with newly diagnosed with cancer receiving chemotherapy. The program consisted of 20- to 30-minute sessions with a nurse and occurred monthly for two visits and bimonthly for two more visits. Participants were offered this intervention along with their treatment. Training of the oncology RNs at the National Cancer Institute in Singapore included personal training by a psychiatrist and a psychologist on psychoeducation for managing stress, sleep hygiene, anxiety, and depression and included resources, deep breathing exercises, muscle relaxation, and inspirational self-talk. Patients also received counseling, supportive therapy, and printed/audio education to encourage practice at home. The RN training also included simulated one-on-one sessions with feedback on performance. Demographic and medical data were collected. Primary outcomes were measured by questionnaires at baseline and at six months.

Sample Characteristics

  • N = 63
  • AGE = Older than 21 years
  • MEDIAN AGE = 51–60 years
  • MALES: 35%, FEMALES: 65%
  • CURRENT TREATMENT: Chemotherapy

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: National Cancer Institute-Singapore Medical Oncology Clinic

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

  • Quasiexperimental study

Measurement Instruments/Methods

  • Distress Thermometer (DT)
  • Hospital Anxiety and Depression Scale (HADS)
  • EuroQol EQ-5D
  • Data were analyzed using SPSS, version 22.

Results

One hundred twenty-one participants were recruited. Seventy (58%) chose to participate, and the rest received treatment as usual (TAU). Sixty-three (90%) participants completed the four nurse-led sessions and were available at six months for reassessment. No significant demographic difference was reported between the intervention and TAU groups at baseline. No significant demographic difference existed between those followed up with and those lost to follow-up, but those lost to follow-up did have higher anxiety and depression scores at baseline. The intervention group had significantly increased distress, anxiety, and depression scores and lower EQ-5D scores at baseline. The intervention group participants had significantly reduced distress (p = 0.001), anxiety (p < 0.001), and depression (p < 0.001) scores, as well as greatly improved quality of life over time. Participants receiving TAU also showed a decline in anxiety and depression over time, with essentially stable distress scores.

Conclusions

A six-month intervention of psychoeducation, counseling, and behavior technique teaching improved participants’ distress, quality of life, anxiety, and depression.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Questionable protocol fidelity
  • Subject withdrawals ≥ 10%

Nursing Implications

Program inclusion of patients helped to individualize nurse-led interventions and enhanced screening tools to capture a larger participation group and encourage completion. This showed that the psychoeducational intervention used here reduced anxiety and depression among the newly diagnosed patients. The low recruitment rate and dropout rate, however, suggest that the program may not have been practical or of interest to many patients. Greater individualization of content may be important for patient participation in this type of intervention. This program is likely to be most beneficial to individuals with higher anxiety and depression symptoms at baseline.
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Merckaert, I., Lewis, F., Delevallez, F., Herman, S., Caillier, M., Delvaux, N., . . . Razavi, D. (2016). Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: A randomized clinical trial comparing the benefits of single-component and multi-component group interventions. Psycho-Oncology. Advance online publication. 

Study Purpose

To compare the benefits of two interventions on anxiety in women after initial treatment for breast cancer

Intervention Characteristics/Basic Study Process

Women were randomly assigned to study groups in cohorts of 12 patients. One group received 15 sessions of a single-component support intervention, and the other received a 15-session group intervention combining support with psychoeducational interventions focusing on problem-solving skills, optimizing communications and use of personal and social resources, and self-hypnosis. Interventions were delivered in group settings by clinical psychologists following a structured manual. Sessions were audio and video recorded for use in clinical supervision as needed. Psychologists delivered only one type of intervention to avoid contamination. Study measures were obtained at baseline and after the intervention. All instruments were used with dynamic tasks through completion of the Mental Adjustment to Cancer (MAC) Scale followed by 12 minutes of self-relaxation and through completion of the Fear of Cancer Recurrence Inventory (FCRI) followed by a 12-minute guided hypnosis exercise.

Sample Characteristics

  • N = 159 in ITT, 130 completed the study   
  • MEAN AGE = 50.6 years (SD = 10.1 years)
  • AGE RANGE = 30–82
  • FEMALES: 100%
  • CURRENT TREATMENT: Radiation 
  • KEY DISEASE CHARACTERISTICS: Women were either receiving radiotherapy or had completed radiotherapy within the past month; 79% had stage 1 or 2 disease.
  • OTHER KEY SAMPLE CHARACTERISTICS: Forty-four percent were married or cohabitating, 17% were working full-time, and 66% had a high school or more education.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: France

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Study Design

  • Randomized, parallel-group trial

Measurement Instruments/Methods

  • 10-cm visual analog scale (VAS) for anxiety
  • Heart rate
  • Relaxation strategies questionnaire
  • Hospital Anxiety and Depression Scale (HADS)
  • Rating of everyday level of anxiety
  • Mental Adjustment to Cancer (MAC) Scale
  • Fear of Cancer Recurrence Inventory (FCRI) 

Results

A significant group by time effect was observed in the multicomponent intervention compared to controls for state anxiety after self-relaxation (p = 0.006), for anxiety after guided hypnosis (p = 0.013), and for everyday anxiety level (p = 0.005). No differences were reported between groups in HADs scores. Anxiety and depression scores declined over time in both groups (p < 0.001). The item of psychological distress on the FCRI was reduced in both groups over time, with slightly better improvement in the multicomponent intervention group (p = 0.017).

Conclusions

Both supportive and multicomponent interventions were associated with a decline in anxiety and depression scores over time. The findings suggest that the multicomponent intervention was more effective in enabling women to manage their level of anxiety from triggers that could produce anxiety.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Subject withdrawals ≥ 10%  
  • No report of any differences existed between groups in general demographic and disease variables that could have influenced the results.

Nursing Implications

Both supportive and multicomponent psychoeducational type interventions were associated with a decline in anxiety and depression over time; however, determining if these changes were associated with the general supportive atmosphere of the group-based intervention is not possible. Anxiety has been shown to decline over time in general as well, without specific intervention. The findings suggest that the combination of self-hypnosis techniques and psychoeducation may enable individuals to manage their anxiety responses more effectively.

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Mohabbat-Bahar, S., Maleki-Rizi, F., Akbari, M.E., & Moradi-Joo, M. (2015). Effectiveness of group training based on acceptance and commitment therapy on anxiety and depression of women with breast cancer. Iranian Journal of Cancer Prevention, 8, 71–76.

Study Purpose

To evaluate the effects of group therapy on anxiety and depression

Intervention Characteristics/Basic Study Process

Acceptance and commitment therapy (ACT) is described as a type of “third wave” of cognitive behavioral therapy that focuses on values and goals clarification and acceptance-based behavioral strategies and mindfulness processes. Participants were randomly assigned to experimental and control groups. The experimental group had ACT held in eight sessions of 90 minutes during four consecutive weeks. These were provided in a group setting. Study measures were obtained at baseline and after the intervention.

Sample Characteristics

  • N= 30
  • MEAN AGE = 47.2 years (range = 29-59)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer, but stages varied.  Standard therapy was completed.

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: Iran

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Beck Depression Inventory
  • Beck Anxiety Scale

Results

Anxiety and depression scores declined in the experimental group, while increasing in the control group. These differences, however, were not statistically significant (p = 0.000).

Conclusions

Findings suggest that a psychoeducational intervention based on acceptance and commitment therapy can be of benefit in reducing anxiety and depression among women with breast cancer.

Limitations

  • Small sample (less than 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: There is no description of the control condition, and apparently no attentional control. Baseline anxiety and depression scores were higher in the experimental group, and other studies have shown that interventions can have a greater effect for those with higher anxiety and depression initially.

Nursing Implications

This type of psychoeducational intervention may be of benefit to reduce anxiety and depression in women with breast cancer. It is not clear to what extent results here were an effect of the protocol used or the participation in group sessions, which could have been supportive.  Psychoeducational interventions are generally low-risk and relatively low-cost approaches that may be of benefit to patients.

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Nguyen, L.T., Alexander, K., & Yates, P. (2018). Psychoeducational intervention for symptom management of fatigue, pain and sleep disturbance cluster among cancer patients: A pilot quasi-experimental study. Journal of Pain and Symptom Management, 55, 1459–1472.

Study Purpose

To assess the feasibility of conducting a trial of a psycho-educational intervention involving the provision of tailored information and coaching to improve management of a cancer-related symptom cluster (fatigue, pain, and sleep disturbance) and reduce symptom cluster effects on patient health outcomes in the Vietnamese context, and to undertake a preliminary evaluation of the intervention.

Intervention Characteristics/Basic Study Process

A parallel-group, single-blind, pilot, quasiexperimental trial with pre-/post-test follow up was conducted in a cancer department of a general public hospital in Hanoi, Vietnam. Participants in the control group received standard treatment. Patient assigned to the intervention group received the psycho-educational program which consisted of three individualized psychoeducational sessions of up to one hour, tailored to meet patient’s major symptom concerns. Strategies such as energy conservation and restorative activities for fatigue management, sleep hygiene for sleep disturbance, and adherence to prescribed therapy for pain management were explored. A patient self-management booklet was provided at the first session to facilitate education and support.

Sample Characteristics

  • N: 102 
  • MEAN AGE: 55.86 years
  • MALES: 40%  
  • FEMALES: 60%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Gastrointestinal, breast, lung, hepatic, and hematologic malignancies

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Hanoi, Vietnam

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care, palliative care

Study Design

Single-blind, pilot, quasi-experimental trial with pre-/post-test follow up.

Measurement Instruments/Methods

  • Numerical Analogue Scales (NAS)
  • Brief Fatigue Inventory (BFI)
  • Brief Pain Inventory (BPI)
  • Hospital Anxiety and Depression Scale
  • EuroQol-5D-5L
  • Intervention Rating Profile-15
  • Symptom self-management diary

Results

The intervention group demonstrated a significant reduction in symptom cluster severity (p < 0.0001), fatigue severity, fatigue interference (p = 0.03), sleep disturbance (p < 0.0001), depression, and anxiety when compared to the control group. For fatigue severity, while the intervention group witnessed no change in fatigue severity (p = 0.4), the control group observed a significant increase (p = 0.01). Depression (p = 0.004) and anxiety (p < 0.0001) decreased significantly in the intervention group, there was significant increase in depression (p = 0.04) and no change in anxiety (p = 0.08) in the control group. There were no significant differences in pain severity, pain interference, functional status, or health-related quality of life.

Conclusions

Psychoeducational interventions may help to achieve improvement in some symptoms such as fatigue and sleep disturbances, but future RCTs are needed to test the effectiveness of a symptom cluster intervention in Vietnam.

Limitations

  • Risk of bias (no appropriate attentional control condition)
  • Unintended interventions or applicable interventions not described that would influence results
  • Findings not generalizable
  • Other limitations/explanation: Non-strict patient randomization, potential for placebo or social desirability effects.

Nursing Implications

Study provides preliminary evidence to support potential efficacy of a psycho-education intervention in improving symptom cluster severity, fatigue burden, sleep disturbance, and psychological distress.

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Oh, P.J., & Kim, S.H. (2010). Effects of a brief psychosocial intervention in patients with cancer receiving adjuvant therapy. Oncology Nursing Forum, 37, E98–E104.

Study Purpose

To test the effects of a brief psychosocial intervention (BPIC) delivered using CD-ROM on psychosocial and behavioral outcomes in patients with cancer undergoing adjuvant treatment

Intervention Characteristics/Basic Study Process

Participants viewed a 15-minute CD-ROM education program and received a booklet as well as 20 minutes of health education in the first session. A follow-up 15-minute telephone session was delivered one week later. The program focused on health education, coping, and stress management.

Sample Characteristics

  • The study reported on a sample of 71 patients with cancer.
  • Of the sample, 29.6% were younger than age 50, and 36.6% were older than age 60.
  • The sample was 62% female and 38% male.
  • Breast cancer was the most frequent diagnosis, followed by lung cancer. A variety of other cancer diagnoses were included.
  • More than 50% of the patients were receiving chemotherapy only, and 37% were receiving chemotherapy plus radiation therapy.
  • The majority of patients were married (90%), not employed (80%), and had a high school or higher education level.

Setting

  • Single site
  • Outpatient setting
  • Korea

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Mental Adjustment to Cancer (MAC) Scale
  • Hospital Anxiety and Depression Scale (HADS)
  • Self-care behavior was assessed with a 20-item tool developed by the author (Cronbach’s alpha = 0.79). Each item was rated 1–7, with higher scores indicating better self-care behavior.

Results

There were no differences between groups for helplessness, hopelessness, anxiety, or depression. There were significant differences in fighting spirit (p = 0.005) and self-care behaviors (p < 0.001) between the two groups. The scores increased in the experimental group but declined in the control group.

Conclusions

Findings support effectiveness of the intervention in improving fighting spirit and self-care behaviors; however, the intervention had no significant effect on anxiety or depression.

Limitations

  • There was a high rate of nonresponders for postintervention measures, which limits the power to detect differences between groups.
  • Findings were done four weeks after the initial study session, so long-term benefits are unknown.

Nursing Implications

Mean anxiety and depression scores at baseline were relatively low, suggesting very limited potential for these outcomes to be significantly improved.

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Owen, J., O'Carroll Bantum, E., Pagano, I., Stanton, A., Owen, J.E., & Pagano, I.S. (2017). Randomized trial of a social networking intervention for cancer-related distress. Annals of Behavioral Medicine, 51, 661–672.

Study Purpose

To evaluate the effects of a web-based social networking and coping skills training intervention on cancer-related patient based outcomes: distress, depression, anxiety, and psychological well-being. Secondary outcomes are vigor and fatigue.

Intervention Characteristics/Basic Study Process

Participants initially completed a baseline survey following which they were given access to the online health space intervention or waitlisted for the intervention (waitlist control group) randomly. Intervention included an evidence-based online distress management intervention for a period of 12 weeks, including modules, chats, discussion boards, and web mails.

Sample Characteristics

  • N = 347   
  • AGE: Treatment group, mean = 52.9 years; waitlist control group, mean = 53.1 years; all combined, mean = 53.1 years
  • MALES: 21%; n = 73
  • FEMALES: 79%; n = 274
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Multiple tumors: Most common were breast cancer (n = 161, 46.4%) followed by prostate cancer (n = 43, 12.4%)
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants with multiple cancers and participants with female reproductive cancers were at 6.1% each (n = 21)

Setting

  • SITE: Multi-site (tumor registry, outreach to websites, and cancer forums)
  • SETTING TYPE: Other (online)
  • LOCATION: Online

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Study Design

Randomized controlled clinical trial

Measurement Instruments/Methods

  • Primary outcomes: distress measured by Distress Thermometer, psychological functioning by Outcomes questionnaire-45, depression by Center for Epidemiologic Studies Depression scale, and trauma-related anxiety by Impact of Event Scale-revised 
  • Secondary outcomes: Fatigue and vigor by the subscales from Profile of Mood States (POM-SF) 
  • Engagement on outcomes: Time spent online with the intervention  
  • Outcomes measured at baseline and 12 weeks.

Results

No baseline difference was noted between the intervention and control group in terms of demographic and clinical characteristics. All the five outcomes improved over time, but no significant difference between the treatment and control group for psychological functioning, depression, anxiety, and vigor. Interaction between time and treatment group fatigue (time fatigue declined in the treatment group compared to control group). No significant reduction in distress and depression between the groups, although it reduced within the groups over time, association between intervention and engagement.

Conclusions

Health space social networking did not improve the cancer-related distress outcomes.

Limitations

  • Unintended interventions or applicable interventions not described that would influence results
  • Questionable protocol fidelity
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Attrition

Nursing Implications

Online interventions could be suggested to patients as it is associated with strong engagement.

Print

Rawl, S.M., Given, B.A., Given, C.W., Champion, V.L., Kozachik, S.L., Barton, D., . . . Williams, S.D. (2002). Intervention to improve psychological functioning for newly diagnosed patients with cancer. Oncology Nursing Forum, 29, 967–975.

Intervention Characteristics/Basic Study Process

The intervention consisted of three parts:

  1. A computer-based nursing intervention that provided assistance with symptom management and information about disease and treatment
  2. Emotional counseling and support
  3. Coordination of services.

The research team created this computer-based intervention for 38 symptoms that may occur during chemotherapy. The computer-based nursing intervention was a menu-driven computer program that guided clinical assessment, problem identification, selection of interventions, and measurement of outcomes. It was designed based on current literature, oncology nursing practice standards, and practice guidelines for cancer symptom management. Each symptom or problem had a problem-specific list of appropriate interventions. Emotional support and counseling consisted of the nurse using active listening and teaching of active communication techniques to patients and their caregivers to enhance communication between patients, caregivers, family, and healthcare providers. The intervention occurred over 18 weeks and consisted of nine visits (five in person and four via telephone). Visits took approximately one hour. Telephone encounters took about 20 minutes.

Dyads were recruited within 56 days of chemotherapy initiation. After completion of baseline telephone interviews, dyads were randomly assigned to groups. Data were collected via telephone interviews at three time points during the six-month study: time 1 = entry into study, time 2 = nine weeks or halfway through the intervention, and time 3 = 24 weeks or one month after the intervention.

Sample Characteristics

  • The study reported on a sample of 109 dyads (patient and identified caregiver).
  • Patients were newly diagnosed with breast, colorectal, or lung cancer and were undergoing chemotherapy.
  • The intervention group had 55 dyads, and the conventional care group had 54 dyads.

Study Design

A randomized controlled trial (RCT) design was used.

Measurement Instruments/Methods

  • Medical Outcomes Study 36–Short Form (SF-36)
  • Center for Epidemiologic Studies–Depression-20 scale (CES-D-20)
  • State-Trait Anxiety Inventory (STAI)–state anxiety
  • Statistical analyses: t tests and repeated ANOVA for SF-36, CES-D-20, and STAI
  • Reliability analyses were completed using Cronbach’s alpha for scales of each time (baseline, time 2, and time 3).

Results

Role emotional, mental health, and mental component scores were significant for the group-by-time intervention (p = 0.1). The intervention did not have a significant effect on anxiety when examining the date from the three time points. However, a trend toward group-by-time interaction (p = 0.09) occurred between baseline and time 2, favoring the intervention group. Pair-wise comparisons of the means showed that the intervention group improved (lower anxiety scores) from baseline to time 2 (p = 0.09), whereas the standard care group remained unchanged. Time 3 data were collected approximately four weeks after completion (24 weeks following enrollment), and any effect the intervention had may have been lost by time 3. Additional analyses were performed on baseline and time 2 data only.

Conclusions

The study was a strong RCT with a good sample size.

Limitations

  • New computer-based nursing intervention was created.
  • The intervention was administered by three advanced practice nurses.
  • The intervention was time-intensive.
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Schofield, P., Gough, K., Lotfi-Jam, K., Bergin, R., Ugalde, A., Dudgeon, P., . . . Aranda, S. (2016). Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: A cluster randomised controlled trial. BMC Cancer, 16, 637-016-2687-1. 

Study Purpose

To investigate the benefits of a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns, and quality of life in men with prostate cancer receiving radiotherapy with curative intent

Intervention Characteristics/Basic Study Process

This phase-III, randomized trial assessed the relative benefits of a tailored, group consultation intervention for men receiving curative intent radiotherapy for prostate cancer compared to the best supportive care. The aim was to communicate information about diagnosis, treatment, and side effects, and coaching in self-management. Content and discussion were based on expressed needs and concerns. It included four group consultation sessions and one individual consultation completed by uro-oncology nurse specialists. Survey assessments occurred before treatment, at the end of treatment, and six months postcompletion of treatment. Sessions were tape recorded, and random selections were used to evaluate intervention fidelity.

Sample Characteristics

  • N = 165 included in analysis of primary outcome   
  • MEAN AGE = 67.2 years (intervention), 67.6 years (usual care group)
  • MALES: 100%  
  • CURRENT TREATMENT: Radiation
  • KEY DISEASE CHARACTERISTICS: Low risk prostate cancer for both groups (about 11%), intermediate risk (prostate cancer control group) (42.3%), prostate cancer risk intervention group (41.1%), high risk prostate cancer (about 47% for both groups) 
  • OTHER KEY SAMPLE CHARACTERISTICS: A little less than 80% were married, 82% were from urban areas, about 78% had previous treatment (e.g., prostatectomy, ADT). Included patients aged 18 years or older with prostate cancer

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Australia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care

Study Design

Phase-III, two-arm cluster, randomized, controlled trial

Measurement Instruments/Methods

  • Hospital Depression and Anxiety Scale (HADS)
  • Cancer Treatment Scale (CaTS)
  • The Short-Form Supportive Care Needs survey questionnaire (SCNS-SF34-R)
  • Expanded Prostate Cancer Index Composite (EPIC-26)

Results

A higher consent rate existed at one site, but no other statistically significant differences in patient characteristics existed between the two groups. One hundred thirteen (out of 165) participants attended all sessions in the intervention group (p = 0.02). Mixed models analysis indicated that group consultations were statistically more beneficial on depressive symptoms (p = 0.009) and procedural concerns relating to cancer treatment (p = 0.049). Ninety-two percent completed surveys at all three time points. Descriptive analysis showed a slight reduction in depressive symptoms in the intervention group between baseline and the end of radiotherapy; the control (usual care) group reported an increase in these symptoms during the same time period. The difference between groups persisted six months post radiotherapy, although between groups, differences in mean changes was substantially reduced. No significant difference existed in rate of change in anxiety between the intervention group and the usual care group noted from the HADS. Descriptive analysis indicated a reduction in anxious symptoms in both groups at the follow-up assessments. Differences in mean changes from baseline to six months post-radiation also occurred, as it did with depressive symptoms.

Conclusions

Nurse-led group consultations may help address patient education, particularly among men who are experiencing depression.

Limitations

  • Findings not generalizable
  • Participants had a baseline high level of baseline functioning.

Nursing Implications

Nurses must realize the importance of patient education and their role in counseling patients experiencing depression not only during treatment but following treatment as part of survivorship care.

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Schofield, P., Jefford, M., Carey, M., Thomson, K., Evans, M., Baravelli, C., & Aranda, S. (2008). Preparing patients for threatening medical treatments: Effects of a chemotherapy educational DVD on anxiety, unmet needs, and self-efficacy. Supportive Care in Cancer, 16, 37–45.

Study Purpose

Primary aim: To evaluate effect of an educational DVD about chemotherapy on pretreatment anxiety, self-efficacy, unmet informational needs, and satisfaction with information received

Secondary aim: To determine if effects differ between those who perceived treatment to be curative rather than palliative

Intervention Characteristics/Basic Study Process

Control group patients received usual care and completed questionnaires before beginning their treatment. Experimental group patients were recruited at a later time. They were given a copy of the DVD to take home to watch, several days before their first treatment. They then completed questionnaires on the first day of chemotherapy treatment. The DVD focused on preparation for chemotherapy and self-management of side effects, including nausea and vomiting, constipation, diarrhea, mucositis, fever and infection, hair loss, infertility, and effects on sexuality and intimacy. Content was evidence-based, derived from a systematic review of the literature to support recommended self-care approaches. Most content was delivered by cancer survivors who also discussed their experiences and the self-care strategies they used to manage side effects. An oncologist and oncology nurse presented medical and nursing information. The DVD was 25 minutes long and had been previously pilot tested. Usual care education consisted of a brief description of the procedure and side effects provided by the patient’s oncologist and a 30-minute education session with a chemotherapy nurse. Analysis was done within curative and palliative care patient groupings.

Sample Characteristics

  • The study reported on a sample of 100 patients.
  • Mean patient age among curative cases was 54 years, and among palliative cases was 56.88 years.
  • The sample was 52% male and 48% female.
  • A variety of cancer diagnoses were represented. The most common types were head and neck, lung, gynecologic, gastrointestinal, and breast cancers.
  • A majority of the sample was employed full- or part-time, and patients were essentially equally distributed across educational levels from less than high school completion to university completion.
  • The majority of patients were married.
  • All patients had not previously received chemotherapy treatment.

Setting

  • Single site
  • Outpatient setting
  • Melbourne, Australia

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study used a prospective quasi-experimental design with use of historical controls.

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • Cancer Behavior Inventory (CBI)–version 2: 33-item scale used to measure self-efficacy
  • Supportive Care Needs Survey (SCNS)–short form: 31 items to assess unmet needs
  • Satisfaction with information assessed with four questions on a five-point Likert scale developed for this study

Results

There were no differences in anxiety or depression scores between usual care and intervention groups. Those who watched the DVD rated themselves as more confident about seeking social support than the usual care group (p = 0.044). There were no differences between groups in any supportive care needs that were unmet. Both curative and palliative patients reported having more psychological needs than any other type of care, and reported sexuality as the least needed area. Those in the intervention group were more satisfied with information they had received (p = 0.026) compared to the control group. There were significant differences between self-perceived curative and palliative patients in confidence for maintaining activity (p = 0.028), stress management (p = 0.044), coping with side effects (p = 0.002), maintaining a positive attitude (p = 0.008), managing emotions (p = 0.005), and seeking social support (p = 0.012).

Conclusions

The intervention appeared to have an influence on aspects of self-efficacy and satisfaction with information received. There were no findings to support an effect on anxiety or depression prior to chemotherapy.

Limitations

  • The study did not have an appropriate control group.
  • A convenience sample was used.
  • The sample size was not sufficiently powered to detect differences in measured outcomes.
  • It is not clear how much information provided in the DVD differed from that provided in usual care by chemotherapy nurses and the oncologist.
  • While the DVD was a different format, differences in content were not clear. It was also not clear from the report if intervention patients received the DVD in addition to usual care, or instead of usual care.

Nursing Implications

Prechemotherapy education is an important part of nursing management of these patients, but there is little evidence to guide the timing, content, format, and style of this type of education. Additional research in this area will be helpful to guide nursing practice. The use of adjuncts to direct face-to-face patient teaching and support by nurses may be helpful in the face of workforce shortages and increasing shifts of patient care to suggest that provision of basic information and orientation to the setting are not sufficient approaches to impact feelings of anxiety. Further study of such approaches can be helpful to determine how to best meet patient needs.

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Schou Bredal, I., Karesen, R., Smeby, N.A., Espe, R., Sorensen, E.M., Amundsen, M., . . . Ekeberg, O. (2014). Effects of a psychoeducational versus a support group intervention in patients with early-stage breast cancer: Results of a randomized controlled trial. Cancer Nursing, 37, 198–207. 

Study Purpose

To investigate which approach, psychoeducation or support, provides the greatest benefit to patients with early-stage breast cancer

Intervention Characteristics/Basic Study Process

Women who had undergone surgery for breast cancer were randomly assigned to receive either a support group (SG) or psychoeducational group (PEG). The PEG intervention consisted of health education about breast cancer and side effects of treatments, stress management (including training and a DVR in progressive muscle relaxation), enhancing problem solving skills, and psychological support from research staff and other group members. Sessions were two hours weekly for five weeks. The SG intervention was part of routine care, consisted of three weekly two-hour sessions on topics women introduced for discussion. A surgeon, physical therapist, and a breast cancer survivor attended the group for 30 minutes each to provide information in a question and answer format. Study assessments were done at baseline, at 2 months, 6 months, and 12 months.

Sample Characteristics

  • N = 367  
  • MEAN AGE = 54.75 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer.  Most were stage T1 or T2.  More than 70% had radiotherapy, 50% had chemotherapy, and 60% had endocrine therapy. All had surgery.
  • OTHER KEY SAMPLE CHARACTERISTICS: 67% were married, 38% were employed, and slightly more than 50% had more than a high school education.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Outpatient    
  • LOCATION: Norway

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

  • Randomized, controlled trial with active control

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale
  • Mini Mental Adjustment to Cancer scale
  • Life Orientation Test, revised (measuring optimism and pessimism)

Results

Ninety-seven percent of patients attended all sessions in both groups. Both groups showed significant decline in anxiety. With adjustment for baseline anxiety level, there were no differences in anxiety levels between groups after the intervention. Depression declined significantly in all patients over time, with no difference between groups. At various time points, there were differences in mental adjustment to cancer between optimists and pessimists, but these differences were not consistent, and there were no significant differences at 12 months. Within the first six months, there was greater decline in anxiety and depression among those in the PEG group.

Conclusions

Women in both groups showed reduced anxiety and depression over time. There were no differences in results between those receiving a support group versus a psychoeducational intervention except in the first 6 months. Psychoeducation may be more helpful in the short term at a time when patients are likely to have more distress.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Other limitations/explanation: Unclear if repeated measures could have created a testing effect. Content in both groups was similar, raising the question of whether these two interventions were substantially different from each other. Groups received a different number of sessions, which could have accounted for the few differences seen. 

Nursing Implications

Findings suggest that both psychoeducational and support group interventions can be beneficial to women dealing with breast cancer. In the short term, findings suggest that psychoeducation may yield some greater benefits, but there were no long-term differences based on the type of intervention provided. It may be beneficial to incorporate more psychoeducational components into routine support group and supportive interventions.

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Targ, E.F., & Levine, E.G. (2002). The efficacy of a mind–body–spirit group for women with breast cancer: A randomized controlled trial. General Hospital Psychiatry, 24, 238–248.

Intervention Characteristics/Basic Study Process

The study compared a complementary and alternative medicine (CAM) group intervention to a standard psychosocial support group.

The 12-week standard psychosocial support group meeting was offered weekly. A trained clinical psychologist taught cognitive behavioral therapy using group sharing and supportive therapies. Topics included coping with real-life issues, communication, body image, sexuality, grief, anger, anxiety management, and problem solving.

The 12-week CAM group meeting was offered twice a week. This group was taught meditation, affirmation, imagery, and ritual. Each session was two and one-half hours. The Tuesday session was a one-hour, RN-run, health-series discussion group, with topics including nutrition, exercise, menopause, lymphedema, pain management, sexuality, and others as requested by the group. The next 90 minutes were spent in six yoga classes and six dance therapy sessions. The Thursday session was one hour of experiential work using silent meditation, guided imagery, and writing and drawing exercises. The final 90 minutes was devoted to a discussion group led by a licensed clinical social worker exploring themes of experiential work as well as general support by the group. Topics included relationship with cancer, views of healing, sexuality, body image, death and dying, compassion, anger, forgiveness, and healing.

Sample Characteristics

  • The sample was comprised of 181 women with breast cancer within 18 months of initial diagnosis or who had been diagnosed with metastatic breast cancer.
  • The CAM group had 93 participants; the standard support group had 88 participants.
  • Twenty-seven were randomized to groups but never showed up for either group (6 in CAM group, 21 in standard support group).

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Functional Assessment of Chronic Illness Therapy (FACIT): Quality of life
  • FACIT-Sp: Spiritual Well-being Scale
  • Profile of Mood States (POMS)
  • Principles of Living Survey: Spiritual well-being

Results

  • The CAM group showed significant decrease in distress as measured by POMS.
  • Both groups showed significant decreases on the POMS anxiety subscales.
  • Both groups were essentially equal in producing significant amount of change in anxiety over time.

Limitations

  • In this community, women choosing to participate in the study did so because they were willing or hoping to get into the CAM program: 7 dropped out from the CAM group compared to 17 dropouts from the standard support group.
  • Specialized training was required to facilitate groups teaching cognitive behavioral education.
  • Both groups had high effect size, without sufficient power to detect possible differences between groups on POMS measure.
  • Which CAM intervention of the many offered helped with anxiety was unable to be ascertained.
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Wenzel, L., Osann, K., Hsieh, S., Tucker, J.A., Monk, B.J., & Nelson, E.L. (2015). Psychosocial telephone counseling for survivors of cervical cancer: Results of a randomized biobehavioral trial. Journal of Clinical Oncology, 33, 1171–1179. 

Study Purpose

To study the effects of psychosocial telephone counseling on anxiety, quality-of-life domains, and biomarkers

Intervention Characteristics/Basic Study Process

Eligible patients were randomly assigned to the telephonic intervention or usual care. Those receiving the intervention received a five-minute pre-call to reintroduce the purpose of the intervention and schedule initial sessions. Patients received four sessions of 20-60 minutes for education and counseling for problem solving, social support, communication skill development, and problem identification based on the transactional model of stress and coping. Follow-up letters with session summary and suggested homework assignments were mailed after each session. Surveys were mailed to participants for completion at baseline, 4 months, and 9 months.

Sample Characteristics

  • N = 168 at 4 months, 151 at 9 months  
  • MEAN AGE = 44.75 years
  • FEMALES: 00%
  • KEY DISEASE CHARACTERISTICS: All had cervical cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: More than half had some college education. About 40% were Hispanic.

Setting

  • SITE: Single site  
  • SETTING TYPE: Home  
  • LOCATION: California

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • PROMIS depression short form
  • Brief Symptom Inventory (BSI)
  • Gynecologic Problems Checklist
  • FACT (cervical and general questionnaires)
  • Plasma cytokine measurement

Results

Patients assigned to the intervention had significantly better scores for depression (p = 0.041) and cancer-specific concerns at four months (p < 0.05). There was no difference between groups in anxiety at four months. Patients assigned to the intervention demonstrated continued improvement in gynecologic problems at nine months. At nine months, there was no difference between groups in depression or anxiety.

Conclusions

Longitudinal evaluation of a telephonic psychoeducational intervention among survivors of cervical cancer showed benefit for depression and gynecologic problems in the first four months after the intervention. These differences were not maintained over the longer term.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Participant withdrawals of 10% or greater

Nursing Implications

Telephone-delivered psychoeducational intervention was associated with reduced depression and cancer concerns within the first few months of the intervention; however, these benefits did not appear to be maintained over the longer term. It is possible that there is a need for continued intervention in order to benefit patients in the longer term. Findings suggest that a telephone intervention delivery can be effective, and may be a practical way to be able to deliver this type of intervention, particularly for patients in rural areas, or those otherwise unable to travel to healthcare facilities.

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Willems, R.A., Bolman, C.A., Mesters, I., Kanera, I.M., Beaulen, A.A., & Lechner, L. (2016). Short-term effectiveness of a web-based tailored intervention for cancer survivors on quality of life, anxiety, depression, and fatigue: Randomized controlled trial. Psycho-Oncology. Advance online publication. 

Study Purpose

To present the short-term effects of a web-based computer-tailored intervention on quality of life, anxiety, depression, and fatigue in cancer survivors

Intervention Characteristics/Basic Study Process

A stand-alone web-based computer-tailored intervention (Cancer Aftercare Guide: KNW) was applied that aims to increase cancer survivor quality of life by providing personalized information and support on specific topics by promoting lifestyle changes. The eHealth intervention was based on principles of the problem-solving theory (PST) and cognitive behavioral theory (CBT). The KNW consists of eight training modules on topics of return to work, fatigue, anxiety, depression, social relationship and intimacy, physical activity, diet, and smoking cessation. After online registration, the computer randomly assigned participants to the intervention or waiting control group. Both groups had to complete questionnaires at 3, 6, and 12 months from baseline. The 6 and 12 month measures revealed the effectiveness. Participants filled in baseline questionnaires, modules were selected by the program, and the information was tailored to the participant, resulting in a personalized action plan. After 30 days, participants were invited to a second session to evaluate goal attainment and to set new goals.The program was unrestricted so that participants could self-select modules they wished to use and skip assignments.

Sample Characteristics

  • N = 419   
  • AGE = 18 years or older
  • MALES: 19%, FEMALES: 81%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Any cancer survivor
  • OTHER KEY SAMPLE CHARACTERISTICS: Off treatment for at least four weeks but no longer than 56 weeks; no recurrence; no serious psychiatric, medical, or cognitive impairment

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Netherlands

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Elder care

Study Design

Randomized, controlled trial comparing the KNW intervention with a waiting list control group

Measurement Instruments/Methods

  • Global health status scale
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • Hospital Anxiety and Depression Scale (HADS)
  • Checklist Individual Strength

Results

With the exception of treatment type, the intervention and control group were comparable. Participants in the intervention group used an average of 2.22 modules from first login to last use of 10.67 weeks. The authors indicated that the KNW intervention had a significant effect on increasing emotional and social functioning (p = 0.022, p = 0.011) and decreased depressions and fatigue (d = 0.019, p = 0.007, d = 0.020, p = 0.02) six months after baseline. The only effect for fatigue occurred in participants who used the module Fatigue (p = 0.009). No significant differences existed between groups for anxiety. For those who used the therapist face-to-face component, available effect sizes ranged from 0.26 to 0.38.

Conclusions

While the use of the web-based intervention showed statistically significant results, the effect sizes for depression, anxiety, and social functioning were extremely small. The module use and program were not fully automated and offered direct therapist contact. The authors reported substantially higher effect sizes with therapist contact, raising the question of overall effectiveness of the web-based content.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no appropriate attentional control condition)  
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Key sample group differences that could influence results 
  • Measurement/methods not well described
 

 

Nursing Implications

eHealth interventions, such as web-based PST or CBT approaches, may be useful for improving quality of life in cancer survivors. Further research is necessary to target the desired information and to provide support specifically for fatigue, anxiety, and depression in cancer survivors. The findings showed much greater size of effects with direct therapist intervention, suggesting that an eHealth system may be best used as an initial step in a multicomponent intervention with additional steps, in which increasing intervention is provided based upon patient need and response.

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Williams, S.A., & Schreier, A.M. (2004). The effect of education in managing side effects in women receiving chemotherapy for treatment of breast cancer [Online exclusive]. Oncology Nursing Forum, 31, E16–E23.

Study Purpose

To determine the effectiveness of audiotapes on self-care behaviors, state anxiety, and the use of self-care behaviors and to describe the occurrence and intensity of common side effects in patients with breast cancer

Intervention Characteristics/Basic Study Process

Two 20-minute audiotapes provided information on nutritional management of side effects, exercise, and relaxation techniques along with written transcripts that were professionally developed at a fifth-grade reading level. All participants received standard education for the clinic but not standardized education. The experimental group received audiotapes and transcripts via mail and were provided with a cassette player if they did not have one at home. All participants were interviewed three times via telephone.

Sample Characteristics

The study reported on 70 women with newly diagnosed stage I or II breast cancer starting the first cycle of chemotherapy treatment. Most of the women were receiving docorubicin and cyclophosphamide.

Setting

The setting was outpatient chemotherapy clinics operated by a university center in satellite clinics in rural areas of southeastern United States that covered 29 counties.

Study Design

The design was an experimental, randomized, clinical trial.

Measurement Instruments/Methods

  • The Spielberger State-Trait Anxiety Instrument and modified Nail Self-Care Diary were used.
  • Anxiety and self-care measures were recorded in diaries (nausea, fatigue, taste change, difficulty sleeping).

Results

  • Women who used the audiotapes demonstrated effective self-care behaviors over time, whereas the control group appeared to experiment to find effective self-care behaviors.
  • Anxiety was high in both groups, but the symptoms decreased among women who received audiotapes and telephone calls.
  • The most frequently experienced side effects were fatigue, nausea and vomiting, and taste changes.
  • The number of women reporting nausea and vomiting decreased by half from the first to second self-care diaries.
  • More self-care behaviors were used for nausea and vomiting than any other side effect that patients experienced.
  • Prescription medications were the most frequently used self-care behavior and were effective over time.

Conclusions

  • Informational audiotapes are effective teaching tools.
  • Self-care behaviors can be taught and can be effective in managing side effects.

Limitations

  • The amount and type of information received in clinics and from community was not controlled.
  • A limitation of the study was its small sample size.
  • The telephone intervention may have had a substantial effect on patients’ behaviors. The questions asked during the phone interview reinforced self-care behaviors in the experimental group and provided information to women in the control group that they may not have had otherwise.
  • The age of the population (half were younger than age 50) should be considered.
  • The intervention was expensive; costs were incurred when developing the audiotapes in a studio with a professional speaker.
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Yun, Y. H., Lee, K. S., Kim, Y. W., Park, S. Y., Lee, E. S., Noh, D. Y., . . . Park, S. (2012). Web-based tailored education program for disease-free cancer survivors with cancer-related fatigue: a randomized controlled trial. Journal of Clinical Oncology, 30, 1296–1303.

Study Purpose

To determine if an internet-based, tailored, psychoeducational program was effective in the management of fatigue and other symptoms for patients with cancer-related fatigue.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to a tailored, web-based, health navigation program or usual care. The 12-week intervention program covered energy conservation, physical activity, nutrition, sleep hygiene, pain control, and distress management. The program included online education, health advice, message services, caregiver monitoring, and support and educational sessions. Principles of cognitive-behavioral therapy were used in the program design. The program was provided via a health navigation web site. Study measures were obtained at baseline and at the end of 12 weeks. Intention-to-treat (ITT) analysis was performed using the last observation carried forward for missing values.

Sample Characteristics

  • In total, 243 patients (23% male, 77% female) were included.    
  • Mean age was not provided; 53.5% of the patients were 45 years or older. 
  • Multiple tumor sites were included, with 38.6% being breast cancer.
  • Slightly greater than 94% of the patients had completed high school or higher education. 
  • Global Brief Fatigue Inventory (BFI) scores at baseline were an average of 4.13 across the study groups. 
  • At baseline, mean anxiety score was 6.46 and mean depression score was 5.7. 
  • All patients had fatigue scores at baseline of 4 or greater for at least one week and had completed primary treatment within the past 24 months.

Setting

  • Single site 
  • Home 
  • South Korea

Study Design

The study was a randomized, controlled trial with a wait-list control.

Measurement Instruments/Methods

  • BFI
  • Health-related quality of life (HRQOL)
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnare (EORTC QLQ-C30)
  • Hospital Anxiety and Depression Scale (HADS)
  • Brief Pain Inventory (BPI)
  • Mini Nutritional Assessment (MNA)
  • Medical Outcomes Study (MOS) Sleep Scale

Results

The intervention group had a significantly larger reduction in fatigue scores (p = 0.0011), with an effect size of 0.29 (Cohen’s d). The intervention group also had a greater improvement in anxiety score and several quality of life–related scale scores (p < 0.05). Multiple variables were statistically significant predictors of change in fatigue scores.

Conclusions

Health navigation, the psychoeducational intervention used here, had a slight to moderate positive effect in reducing fatigue.

Limitations

  • The study had risks of bias due to no blinding and no appropriate attentional control condition.
  • Key sample group differences could have influenced the results.
  • Patient withdrawals were 10% or greater. The patient withdrawal rate was 29% overall and 31% in the intervention group.
  • At baseline, BFI scores were lower in the intervention group, so the method of ITT analysis may have overestimated the lower fatigue scores at follow-up for this group.
  • The withdrawal and loss to follow-up rate in the intervention group suggested that the intervention may not be well received by several patients.

Nursing Implications

The findings suggested that a psychoeducational program delivered via a web-based program may be helpful for some patients for the management of fatigue. Although the study was limited by a high withdrawal rate in the intervention group, the majority of patients continued with the program. This may be a practical approach that is helpful to some patients. Further research in the area of facilitating and encouraging patient participation in such programs would be useful.

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Zhang, M., Sally Wai-chi, C., You, L., Wen, Y., Peng, L., Liu, W., & Zheng, M. (2014). The effectiveness of a self-efficacy-enhancing intervention for Chinese patients with colorectal cancer: A randomized controlled trial with 6-month follow up. International Journal of Nursing Studies, 51, 1083–1092. 

Study Purpose

To test the effects of a nurse-led, self-efficacy-enhancing intervention for patients with colorectal cancer compared to routine care over a six-month follow-up period

Intervention Characteristics/Basic Study Process

Verbal and written information on self-efficacy and techniques to increase self-efficacy were distributed, and 20–40 minute coaching follow-up sessions were conducted via telephone. The control group received routine care, which included information provided by the nurse on knowledge of chemotherapy and side effects before patients started treatment (about 30 minutes). The intervention was based on Bandura’s (1977, 1986) self-efficacy theory. The self-efficacy intervention was complex and included an hour-long, face-to-face education session conducted by an oncology nurse, an educational handbook that contained information on the core components of self-efficacy, a 30-minute audiotape on relaxation, and four monthly health-coaching telephone follow-up sessions (20–30 minutes each) with an oncology nurse.

Sample Characteristics

  • N = 121  
  • MEAN AGE = 53 years (SD = 11.3 years)
  • MALES: 64.5%, FEMALES: 35.5%
  • KEY DISEASE CHARACTERISTICS: Colorectal cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Adult Chinese patients diagnosed within the past six months; access to a telephone; could understand and communicate in Chinese; at least 18 years old; patients understood they were diagnosed with cancer and were scheduled to receive chemotherapy after cancer-related surgery

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Multiple settings    
  • LOCATION: Asia

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Elder care, palliative care 

Study Design

Randomized, controlled trial with repeated measures and a two-group design

Measurement Instruments/Methods

  • Self-efficacy was assessed using the Stanford Inventory of Cancer Patient Adjustment (SICPA).
  • Symptom distress was evaluated using the Chinese version of the MD Anderson symptom Inventory (MDASI).
  • Anxiety and depression were measured using the Chinese version of the Hospital Anxiety and Depression Scale (HADS).
  • Quality of life was measured using the Functional Assessment of Cancer Treatment–General (FACT-G).

Results

The intervention group experienced a significant improvement in self-efficacy (f = 7.26, p = .003), a reduction in symptom severity (f = 5.30, p = .01), symptom interference (f = 4.06, p = .025), anxiety (f = 6.04, p = .006), and depression (f = 6.96, p = .003) at three and six months compared to the control group. No statistically-significant main effect was observed in quality of life perception between the two groups.

Conclusions

A nurse-led, self-efficacy-enhancing intervention was effective in promoting self-efficacy and psychological well being for three and six months compared to the control group. The findings of this study suggest that the intervention is feasible, and improvements could be sustained for six months after the intervention.

Limitations

  • Risk of bias (no blinding)
  • Findings not generalizable
  • Other limitations/explanation: Conducted in one cancer center and two affiliated hospitals in southern China; findings might not reflect situations of patients living in other areas of China; only monitored patients up to six months

Nursing Implications

Self-efficacy-enhancing interventions that are lead by nurses may improve the psychological well-being of patients with colorectal cancer.

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Guideline / Expert Opinion

Andersen, B.L., DeRubeis, R.J., Berman, B.S., Gruman, J., Champion, V.L., Massie, M.J., . . . American Society of Clinical Oncology. (2014). Screening, assessment, and care of anxiety and depressive symptoms in adults with cancer: An American Society of Clinical Oncology guideline adaptation. Journal of Clinical Oncology, 32, 1605–1619. 

Purpose & Patient Population

PURPOSE: To screen, assess, and care for anxiety and depression symptoms at various points across the trajectory of care 
 
TYPES OF PATIENTS ADDRESSED: All adult patients with cancer 

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Evidence-based guideline  
 
PROCESS OF DEVELOPMENT: Used the ADAPTE methodology using existing guidelines from another organization; included two parts, a methodologic review and a content review; used the Rigour of Development Domain of the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument
 
DATABASES USED: MEDLINE, EMBASE, CINAHL, and Cochrane library (recent to December 2009); clinical practice guideline databases; guideline developer websites; published literature  
 
KEYWORDS: Not mentioned specifically, but included state documents that addressed screening, assessment, or treatment of psychosocial distress in adults with cancer
 
INCLUSION CRITERIA: Clinical practice guidelines, systematic reviews, and other guidance documents
 
EXCLUSION CRITERIA: Not mentioned

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Pediatrics, elder care, palliative care 

Results Provided in the Reference

The guideline provides an algorithm for the screening and assessment of anxiety, a care map for anxiety in adults with cancer, an algorithm for the screening and assessment of depression, a care map for depression in adults with cancer, the Patient Health Questionnaire (PHQ 9) symptom depression scale and generalized anxiety disorder (GAD) items, and selected measures for depression and anxiety (modified).

Guidelines & Recommendations

  • Before the implementation of guidelines, referral systems and resources should be identified and available in each institution.
  • The guidelines are designed for healthcare providers, patients, family members, and caregivers to guide in the screening, assessment, and treatment approaches of adult patients with cancer who have anxiety and depression at any stage of the cancer continuum, regardless of cancer type, disease stage, or treatment modality. 
  • All patients with cancer and cancer survivors should be evaluated for the symptoms of anxiety and depression with validated instruments at periodic times during the cancer care. Treatment recommendations are based on the levels of symptoms. Follow-up care and reassessment are important in this setting to monitor for follow-through, compliance with referrals, and pharmacologic management. If compliance is poor, develop a plan. After eight weeks of treatment, if symptoms are not improved or poor compliance is noted, alter the treatment course and add a psychological or pharmacologic intervention. The guidelines recommend that individual psychological interventions be delivered by a licensed mental health professional, which may include cognitive and behavioral strategies, education and relaxation strategies, group psychosocial interventions, and physician-prescribed antidepressants. 

Limitations

  • A guideline that has been adapted from another country often can't lend itself to different policies or cultural influences.
  • Some of the recommendations were removed from the original guideline because of references to the Edmonton Symptom Assessment Scale screening measure, which is not widely used in the United States.

Nursing Implications

Nurses play a vital role in the early screening, assessment, and treatment of patients who may have significant symptoms of anxiety and depression. By screening and making appropriate referrals, we can impact the emotional, interpersonal, and financial costs for patients and reduce the economic impact for providers and the healthcare system.

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Butow, P., Price, M.A., Shaw, J.M., Turner, J., Clayton, J.M., Grimison, P., . . . Kirsten, L. (2015). Clinical pathway for the screening, assessment and management of anxiety and depression in adult cancer patients: Australian guidelines. Psycho-Oncology, 24, 987–1001. 

Purpose & Patient Population

PURPOSE: To provide a clinical pathway for anxiety and depression in adult patients with cancer to guide best practice
 
TYPES OF PATIENTS ADDRESSED: Adult patients at any phase of care and type of cancer

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Consensus-based guideline
 
PROCESS OF DEVELOPMENT: A review of existing guidelines and systematic reviews relevant to the purpose of the guideline was conducted. Structured interviews with 12 multidisciplinary staff from varied institutions were done, followed by an online Delphi process with 87 stakeholders representing multiple disciplines. Additional input was obtained from a multidisciplinary advisory panel.
 
DATABASES USED: Cochrane, Google, PubMed, Medline, PsycInfo, and CINAHL
 
KEYWORDS: not stated

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results Provided in the Reference

No information is provided regarding literature retrieved, quality of evidence, or how the evidence was used to develop the guidelines provided.

Guidelines & Recommendations

Outlines relevant healthcare provider roles. Identified the following assessment tools for use: Edmonton Symptom Assessment Scale, the NCCN's Distress Thermometer, and the Hospital Anxiety and Depression Scale. Provides a stepped path of interventions based on ongoing monitoring of symptoms and effectiveness of previous interventions. Recommendations for initial intervention are patient education (in-person or online) and brief emotional support. Ongoing interventions for those with cancer-related anxiety and depression include coping skills training, relaxation skills, communication skills, mindfulness, and a variety or psychological therapies.

Limitations

Despite an extensive review process for guidelines, as well as input from stakeholders, there is little information on the evidence base for the recommendations provided.

Nursing Implications

This guideline outlines recommended providers, and nurses are not specifically outlined as recommended providers in the written pathway other than as “other appropriately trained staff,” although nurses are identified as having roles in screening, assessment, and educational and counseling types of roles. This guideline provides no new information and does not directly provide the evidence base on which recommendations are based. The guideline suggests more limited roles for nurses than has been demonstrated in relevant research.

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National Comprehensive Cancer Network. (2012). NCCN clinical practice guidelines in oncology: Distress management [v.2.2013]. Retrieved from http://www.nccn.org/professionals/physician_gls/pdf/distress.pdf

Purpose & Patient Population

To provide clinical practice guidelines for the evaluation and treatment of distress — a normal feeling of vulnerability to a feeling that leads to disabling problems, such as depression and anxiety — in adult patients with cancer

Type of Resource/Evidence-Based Process

  • Evidence-based guidelines    
  • Consensus development involving a panel composed of physicians, psychiatrists, psychologists, and social workers

Phase of Care and Clinical Applications

  • Phases of care: multiple phases 
  • Clinical application: palliative care

Results Provided in the Reference

Results were not stated.

Guidelines & Recommendations

Recommended standards of care include

  • Screening all patients for distress, at initial visits and appropriate intervals
  • Distress management according to guidelines
  • Having committees to implement standards, provide relevant education and training to healthcare professionals
  • Having mental health professionals and certified chaplains available
  • Providing a distress-thermometer screening tool
  • Identifying at-risk patients and periods of increased vulnerability, to define appropriate screening intervals

Evaluation should include measures relating to level of distress, behavior symptoms, psychiatric history and medications, pain and symptom control, body image and sexuality issues, impaired capacity, safety, potential medical causes, and psychological disorders.

Management algorithms should be provided for dementia, delirium, mood disorder, psychotic disorder, adjustment disorder, anxiety disorder, personality disorder, and substance-related disorder.

Treatments identified for use include psychotherapy, anxiolytics, antidepressants, psychoeducation, cognitive behavioral therapy, social work and counseling interventions, spiritual counseling and ethics, and palliative care consultation according to algorithms.

Limitations

  • The evidence is mainly \"lower level,\" and recommendations are primarily consensus-based. 
  • The panel did not include a nursing member.
  • Many recommendations tend to focus on approaches to care for patients with significant mental disorders or for those referred to a mental health team. 
  • The guidelines provide limited suggestions regarding low-level distress associated with physical symptoms.

Nursing Implications

The guidelines provide recommended pathways regarding assessment and management of distress. They do not provide a nursing perspective or identify a role for nursing in patient management.

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