Effectiveness Not Established

Supportive Care/Support Interventions

for Anxiety

Supportive care involves the provision of emotional support informally or through structured interventions. Support interventions include activities such as general counseling related to emotional and other issues, active listening, and presence. Supportive interventions may be provided by healthcare professionals or may be structured as peer group support. Interventions can be one-on-one individualized sessions, support group sessions, or specific interventions with caregivers, families, etc. Support interventions may be provided via telephone, physical presence, or online groups that may be either referereed by a professional or unrefereed. Expressive writing for emotional disclosure can be seen as a specific type of supportive intervention; however, it is not grouped in the intervention of supportive care. Expressive writing, as a very specific approach, is evaluated in ONS PEP resources as its own type of intervention. Supportive care/support interventions have been evaluated in patients with cancer for anxiety, caregiver strain and burden, chemotherapy-induced nausea and vomiting, and depression

Systematic Review/Meta-Analysis

Moore, T.H., King, A.J., Evans, M., Sharp, D., Persad, R., & Huntley, A.L. (2015). Supportive care for men with prostate cancer: Why are the trials not working? A systematic review and recommendations for future trials. Cancer Medicine, 4, 1240–1251. 

Purpose

STUDY PURPOSE: To examine the effect of a variety of supportive care measures on quality of life (QOL), depression, anxiety, coping skills, and self-efficacy among men with prostate cancer in various states of care. (Note: Many more outcomes were reported among studies, but the four above were the most frequent.)

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, CINAHL, CENTRAL, and PsycInfo. Reference lists of retrieved studies were reviewed for additional references. Select authors were asked for unpublished study papers. 
 
INCLUSION CRITERIA: Randomized, controlled trials and controlled trials that addressed supportive interventions in any phase of prostate cancer treatment 
 
EXCLUSION CRITERIA: Studies of participants at risk for prostate cancer, with advanced cancer, or in the final days of life; pharmaceutical trials (herbal medicines, nutritional supplements); studies of decision aids

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 5,618 records
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two authors screened titles and abstracts separately according to the inclusion and exclusion criteria. The authors maintained a table of numerous data extraction characteristics and decision points. Risk of bias was assessed by one author and evaluated for accuracy by another. Discrepancies and disagreements were resolved by discussion with a third review.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 26  
  • TOTAL PATIENTS INCLUDED IN REVIEW = 2,740 participants
  • SAMPLE RANGE ACROSS STUDIES: Less than 50 to over 200. Seven were pilot studies. 
  • KEY SAMPLE CHARACTERISTICS: Twenty studies were based in the USA (most were government-funded or national research groups), two were based in Canada (similar funding as in USA), and others were based in Ireland, Sweden, or Hong Kong. Other funding sources were public, private, or not described. Seven studies were rated at high risk for bias. One study included patients with breast cancer and prostate cancer in the power calculation. Control group designation, services, or support were inconsistently described across trials.

Phase of Care and Clinical Applications

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

Results

Eight of 26 studies reported primary and secondary outcomes among a variety of measured outcomes. Studies were conducted using various measures and at various stages of treatment and for varying durations. Small numbers of trials were reported for specific interventions: two trials for buddy support, two studies for relaxation therapy, and one study for psychoeducational support.
 
Quality of Life: No significant or consistent standard mean differences or direction for QOL
 
Depressive symptoms and mood (14 trial studies) and anxiety (three trial studies) were reported together. The results were mixed. Trends were positive overall for depressive symptoms, mood, and anxiety. Confidence intervals were wide, and no positive effects on anxiety existed. One study showed a significant (p = 0.006) positive effect on depression after presurgical stress management at one week before surgery but no difference between groups on the morning of surgery.
 
Coping and Self-Efficacy: Insufficient data to determine the effect in pretreatment or during the treatment phase of care
 
Costs and Cost Analysis: Not reported in the trials reviewed

Conclusions

Most trials reported no effect of supportive care measures on the stated outcome variables. The findings indicated appropriate interventions and outcomes measures, but small samples with insufficient power contributed to lack of evidence for improvements. Recommendations included resources to support the design, conduct of trials, and reporting (CONSORT guidelines) improvements. Also included were recommendations to diversify sampling across sociodemographic profiles to include unpartnered men who may be less likely to have a social support network, address all stages of care, provide clear descriptions of usual care and control group activities, and use reliable and valid outcome measures.

Limitations

  • Mostly low quality/high risk of bias studies
  • Minimal confidence can be put in the study findings as a result of the design and analysis limitations.

Nursing Implications

The value of this systematic review is that supportive care probably works, but the evidence is lacking because of inconsistencies in study design and reporting. Clear, perhaps standardized, descriptions of the broad variety of interventions called \"supportive care\" are needed. Comparative information was not available across more than two to six trials of a particular intervention. The effect of supportive care in patients with prostate cancer can be examined by creating studies that have strong design quality and methodology. The authors’ provide important recommendations for study areas to be addressed so that results are comparable. One finding is seldom sufficient to change or influence practice.

Print

Slev, V.N., Mistiaen, P., Pasman, H.R., Verdonck-de Leeuw, I.M., Uden-Kraan, C.F., & Francke, A.L. (2016). Effects of eHealth for patients and informal caregivers confronted with cancer: A meta-review. International Journal of Medical Informatics, 87, 54–67. 

Purpose

PURPOSE: To synthesize evidence regarding effects of eHealth in patients with cancer and informal caregivers from systematic reviews

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, EMBASE, CINAHL, PsycINFO, and the Cochrane Collaboration
 
KEYWORDS: Multiple terms for eHealth, cancer, systematic review, and meta analysis
 
INCLUSION CRITERIA: Systematic reviews reporting the effects of eHealth were included. EHealth was defined as the provision of information and/or support for patients or caregivers. Only minor or minimal flaws existed in the review.
 
EXCLUSION CRITERIA: Studies including patients without cancer were only included if the results for cancer were reported separately.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 8,157
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Quality assessment checklist for reviews; studies were only included if scores were at least of moderate quality

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 10
  • TOTAL PATIENTS INCLUDED IN REVIEW = Not reported
  • SAMPLE RANGE ACROSS STUDIES: Not reported
  • KEY SAMPLE CHARACTERISTICS: Varied tumor types; mostly breast, prostate, and head and neck cancers

Results

Evidence was found for positive effects of eHealth on knowledge and perceived support. The findings regarding effects on decision-making were inconsistent. Interventions had some positive effects on patient involvement in healthcare. The findings regarding the effects of Internet support groups on anxiety and depression were mixed. Most interventions were Internet-based and had multiple components of education, support, chat groups, and communications with providers. One study used smart phone applications.

Conclusions

EHealth applications have been shown to have a positive effect on knowledge. Its effects on other aspects of the patient experience are inconsistent.

Limitations

All but one study were of moderate quality. Studies of low quality were excluded. Types of programs and components varied greatly, making the synthesis of effects for discrete interventions difficult.

Nursing Implications

eHealth applications may be a useful and practical way to provide patient and caregiver education. Its effectiveness as an intervention for psychological well-being and other outcomes was not clear given the mixed evidence. Ongoing research is needed to determine the full range of potential effects, program components that are most helpful, and needed duration of use for positive effects.

Print

Research Evidence Summaries

Ando, M., Morita, T., Okamoto, T., & Ninosaka, Y. (2008). One-week Short-Term Life Review interview can improve spiritual well-being of terminally ill cancer patients. Psycho-Oncology, 17, 885-890.

Study Purpose

To assess the efficacy of a Short-Term Life Review process on spiritual well- being, anxiety, depression, suffering, and happiness in terminally ill patients with cancer

Intervention Characteristics/Basic Study Process

The intervention was Short-Term Life Review completed with a psychologist, who then created an album based on the participant’s interview. In the first part, participants reviewed their life, and in the second, they reevaluated, reconstructed, and appreciated their life. In the second session, the album was reviewed with the participant.

Sample Characteristics

  • The study reported on a sample of 30 patients with cancer.
  • Mean patient age was 74 years (SD = 9.1).
  • The sample was 73.3% female and 26.7% male.
  • Multiple tumor sites were represented.
  • Of the sample, 90% had no specific religious affiliation, and 96.7% were married.
  • Mean time from interview to death was 67 days.

Setting

  • Single site
  • Inpatient setting
  • Japan

Phase of Care and Clinical Applications

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

Study Design

A prospective pre/post-test design was used.

Measurement Instruments/Methods

  • Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being (FACIT-Sp) – Japanese version
  • Hospital Anxiety and Depression Scale (HADS) – Japanese version
  • Numeric rating scales for suffering (0–6) and happiness (1–7)

Results

Anxiety and depression scores significantly decreased (p = 0.001).

Conclusions

The Short-Term Life Review process is feasible for terminally ill patients and appears to be beneficial to reduce anxiety and depression, reduce suffering, and improve happiness.

Limitations

  • Statistical significance may not impart sufficient clinical significance for such an intensive intervention.
  • The study did not have a control group.

Nursing Implications

  • Cultural differences may affect efficacy; further study is required.
  • The intervention was completed by a trained psychologist and required a large time investment to create the album.
Print

Badger, T., Segrin, C., Dorros, S.M., Meek, P., & Lopez, A.M. (2007). Depression and anxiety in women with breast cancer and their partners. Nursing Research, 56, 44–53.

Intervention Characteristics/Basic Study Process

This intervention provided telephone-delivered psychosocial interventions.

One group received six weeks of telephone-delivered counseling (TIP-C) sessions based on interpersonal psychotherapy/counseling principles, covering the following topics.

  • Cancer education
  • Social support
  • Awareness and management of anxiety symptoms
  • Role transitions

These phone calls averaged 34 minutes.

A second group received six weeks of telephone-delivered, self-managed exercise protocol information. The exercise protocol consisted of engaging in regular, low-impact exercise (e.g., walking for a prescribed number of minutes at least four times per week). These phone calls averaged 11 minutes.

A third group received six weeks of attention control (AC) printed information about breast cancer with brief weekly phone calls averaging seven minutes. This group did not receive counseling or encouragement to exercise.

Data were collected at baseline (T1), one week after the final call (T2), and one month after the final call (T3).

Sample Characteristics

  • The study reported on a convenience sample of 96 women with breast cancer and 96 partners (N = 192).
  • Participants were randomized to three groups, stratified by stage and treatment.
    • Group 1 consisted of 38 women and 38 partners.
    • Group 2 consisted of 21 women and 19 partners.
    • Group 3 consisted of 33 women and 30 partners.
  • There were no significant differences between groups for treatment, stage, history of depression, participation in support groups or counseling, and use of antidepressants or antianxiety medications.

Study Design

The study used an experimental design: three-wave repeated measures with a between-subjects factor (treatment group).

Measurement Instruments/Methods

  • Positive and Negative Affect Schedule (PANAS) PLUS
  • Index of Clinical Stress to make eight-item composite index of anxiety
  • Instruments used have established reliability and validity.

Results

Both telephone counseling and exercise conditions helped to significantly reduce anxiety in women and their partners (p < 0.001). The AC group did not evidence the same improvement in decreased anxiety, and their partners’ anxiety scores increased. The authors reported mixed-model ANOVA significant effect for time (p = 0.001), no significant main effect for treatment group, and significant group x time interaction (p = 0.01).

Nursing Implications

The intervention required special training needs of a psychiatric nurse counselor with oncology expertise to deliver the telephone counseling sessions. These 34-minute (on average) phone calls per weekly session (x 2—one per patient and one per partner) required more than one hour per week per couple of time to deliver the intervention.

Print

Björneklett, H.G., Lindemalm, C., Rosenblad, A., Ojutkangas, M.L., Letocha, H., Strang, P., & Bergkvist, L. (2012). A randomised controlled trial of support group intervention after breast cancer treatment: Results on anxiety and depression. Acta Oncologica, 51, 198–207.

Study Purpose

To evaluate the effect of a support program on anxiety and depression in patients with breast cancer

Intervention Characteristics/Basic Study Process

The intervention was a weeklong multidisciplinary residential program. The intervention took place within four months after the end of tumor treatment and ran for seven days, followed by four days of follow-up two months after the initial visit. The team consisted of oncologists, social workers, art therapists, massage therapists, a dietitian, and a mindfulness practitioner.

Sample Characteristics

  • The study reported on a sample of 382 female patients with breast cancer; 309 completed the 12-month follow-up.
  • Mean ages in the treatment group were 54 years (range = 30–69) and 61 years (range = 34–84).
  • Mean ages in the control group were 55 years (range = 38–70) and 62 years (range = 38–83).
  • Patients were subgrouped into whether they had chemotherapy or not. Patients had either breast-conserving surgery or mastectomy. Those with breast-conserving surgery or lymph node involvement also received radiation therapy.

Setting

  • Single site
  • Retreat center setting
  • Sweden

Phase of Care and Clinical Applications

  • Transition phase of care
  • Late effects and survivorship

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

Hospital Anxiety and Depression Scale (HADS)–Swedish version

Results

After 12 months, 10% in the intervention group versus 19% in the control group had a high anxiety score (p = 0.055).

Conclusions

Support group intervention including education about the disease and psychological reactions, mixed with art and dance therapy, qigong, and relaxation, was shown to positively influence anxiety levels among patients with breast cancer over time, whereas depression levels were unaffected by the intervention.

Limitations

  • A variety of interventions and providers were used, limiting the ability to transfer the findings to other venues.
  • Reproducibility is an issue.
  • The study had no appropriate attentional control.

Nursing Implications

Because of costs and time constraints, the ability of this program to be replicated is suspect. The particular components of the program that provided the most effectiveness were not analyzed and therefore cannot be reproduced or further studied.

Print

Björneklett, H.G., Rosenblad, A., Lindemalm, C., Ojutkangas, M.L., Letocha, H., Strang, P., & Bergkvist, L. (2013). Long-term follow-up of a randomized study of support group intervention in women with primary breast cancer. Journal of Psychosomatic Research, 74(4), 346–353.

Study Purpose

Long-term follow-up to evaluate quality of life after support group intervention in a randomized group of women with primary breast cancer presenting for postoperative radiotherapy.

Intervention Characteristics/Basic Study Process

The current study is a long-term follow-up 5–9 years after randomization into groups. The intervention and control groups were stratified by chemotherapy or nonchemotherapy treatment. The intervention was a one-week support group with four days of follow-up two months postintervention during residential care at the Foundation of Lustgården Mälardalen. The intervention involved lectures and group discussions about the etiology of cancer, risk factors, treatment, physical and psychological effects, and coping strategies. Patients engaged in physical exercise, relaxation, Qigong, and nonverbal communication exercises, as well as art and dance therapy. All participants completed questionnaires at baseline and follow-up questionnaires at 2, 6, and 12 months postintervention. The control group participated only in routine follow-up at the Department of Oncology or the Department of Surgery.

Sample Characteristics

  • N = 382 (final sample); 191 in intervention group and 191 in control group
  • AGE RANGE: 30–83
  • MALES: 0 %, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients were newly diagnosed with primary breast cancer at the beginning of the parent study.

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient   
  • LOCATION: Department of Oncology at the Central Hospital in Västeräs, Sweden

Phase of Care and Clinical Applications

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

Study Design

  • Prospective randomized trial
    • Long-term follow-up comparison of test scores at baseline, 12 months, and at end

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • European Organisation for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)
  • Fatigue Questionnaire (FQ)

Results

Fatigue symptoms improved over time, which was a significant finding in the intervention and control groups. Being upset about hair loss improved over time in the intervention group. High anxiety scores improved over time and were not significantly different between the two groups in long-term follow-up. Depression scores were high at follow-up for seven women in each group, and no significant difference was found at baseline and postintervention, adjusting for covariates. Neither group showed improvement between the 12-month follow-up and long-term follow-up. 

Conclusions

Effects of support group intervention may provide a sense of security that can fade over time, reversing improvements in anxiety and depression. Treatment-related fatigue may improve over time. Significant improvement was found in cognitive function, body image, and future perspective, but no significant effect was found on levels of anxiety and depression.

Limitations

  • An average of 6.5 years elapsed between the parent study and the follow-up study.
  • Participants were lost to follow-up between the parent study and the follow-up study.
  • No initial need for an intervention was conducted.

Nursing Implications

Women who have received chemotherapy have greater symptom severity and may benefit more on global health and cognitive function fatigue, when compared to women who have not received chemotherapy. Additional research is needed to evaluate the influence of exercise and psychosocial support interventions, according to patient needs for content, duration, and an assessment of spiritual well-being using the Functional Assessment of Chronic Illness Therapy (FACIT).

Print

Cameron, L.D., Booth, R.J., Schlatter, M., Ziginskas, D., & Harman, J.E. (2007). Changes in emotion regulation and psychological adjustment following use of a group psychosocial support program for women recently diagnosed with breast cancer. Psycho-Oncology, 16, 171–180.

Intervention Characteristics/Basic Study Process

A 12-week structured psychosocial support group of weekly two-hour sessions was led by two facilitators using an adapted form of Cunningham’s “Healing Journey” program. The intervention included training in relaxation, guided imagery, meditation, emotional expression, and exercises promoting control beliefs and benefit-finding. The prospective design included 10 phases to recruit, and 8–11 women were recruited for each group. Data were collected at baseline and at 4 months (corresponding to the end of the intervention), 6 months, and 12 months.

Sample Characteristics

  • The study reported on a sample of women newly diagnosed with breast cancer.
  • Women participated in one of three conditions: intervention group (n = 54), standard care group (n = 44), and decliner group who refused the intervention (n = 56).

Setting

New Zealand

Study Design

A quasi-experimental study design was used.

Measurement Instruments/Methods

  • Cortauld Emotional Control Scale: emotional suppression
  • Illness Perceptions Questionnaire–Revised: perceived control
  • Perceived Risk of Recurrence: two items, 1–10 scale
  • Benefit-Finding Scale for Breast Cancer
  • Functional Assessment of Cancer Therapy (FACT): emotional well-being subscale
  • Cancer Worry: two items, 1–10 scale
  • State-Trait Anxiety Inventory: state anxiety
  • Coping Efficacy: measured five items

Results

Repeated measures ANOVAs revealed group differences in state anxiety over the first four months. Scores decreased for intervention participants, but not the standard care or decliner participants. Anxiety decreased overall from baseline to 6 months and from baseline to 12 months. Longitudinal follow-up occurred over 12 months.

Limitations

  • The study had no randomization.
  • The study had a high level of decliners.
  • The intervention required special training of facilitators to use the program.
Print

Chujo, M., Mikami, I., Takashima, S., Saeki, T., Ohsumi, S., Aogi, K., et al. (2005). A feasibility study of psychosocial group intervention for breast cancer patients with first recurrence. Supportive Care in Cancer, 13, 503–514.

Intervention Characteristics/Basic Study Process

The intervention was a six-week structured psychosocial support group of 90 minutes led by a male psychiatrist and nurses with experience in facilitation cancer groups. Each group member received

  • 20 minutes for stress-management method and problem-solving method
  • 50 minutes for discussion on coping
  • 20 minutes for learning progressive muscle relaxation (PMR) and audiotapes to use twice a day.

Measurements were done at baseline, then immediately following the six-week intervention, then three months and six months later.

Eleven women refused to participate but were interested in group intervention and consented to answering questionnaires. These women were given materials after completion of the survey and the PMR tape.

Sample Characteristics

  • The participants were Japanese women with first recurrence of breast cancer (recurrence within three months to one year of initial diagnosis).
  • The intervention group consisted of 28 participants (19 finished the trial); 11 women refused to participate.

Study Design

The study design was quasi-experimental without a control group.

Measurement Instruments/Methods

  • Profile of Mood States (POMS)
  • Impact of Event Scale–Revised
  • Mental Adjustment to Cancer Scale
  • EORTC Quality of Life Questionnaire—Cancer 30/Breast module 23 (QLQ-C30/Br23)
  • Dunnett’s test to examine changes in scores between baseline and at three and six months after the intervention

Results

Results in the intervention group revealed significant changes in scores for tension-anxiety on POMS in the period up to three months after the intervention; no differences were noted at six months after the intervention.

Limitations

  • The study had a nonrandomized design.
  • The study had a small sample size.
Print

Kao, C.Y., Hu, W.Y., Chiu, T.Y., & Chen, C.Y. (2014). Effects of the hospital-based palliative care team on the care for cancer patients: An evaluation study. International Journal of Nursing Studies, 51(2), 226-235.

Study Purpose

To evaluate the effects of the hospital-based palliative care team on care for patients with cancer

Intervention Characteristics/Basic Study Process

The hospital-based palliative care team visited intervention patients “regularly” during the one-week study period. Team members including physicians, nurses, chaplains, and social workers provided advice about medications and taught patients and families skills to relieve physical symptoms, provided emotional support, and assisted with truth-telling and preparation for death. Data were collected at baseline and one week later.

Sample Characteristics

  • N = 60
  • MEAN AGE = 57.5 years (SD = 14.62)
  • MALES: 57%, FEMALES: 43%
  • KEY DISEASE CHARACTERISTICS: Patients with advanced cancer with palliative care needs
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients hospitalized in a medical center in Taiwan; unlikely to die or be discharged in 24 hours

Setting

  • SITE: Single site
  • SETTING TYPE: Inpatient   
  • LOCATION: Taipei, Taiwan

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Study Design

Quasi-experimental study with a pretest-posttest design

Measurement Instruments/Methods

  • Symptom Distress Scale (SDS)
  • Hospital Anxiety and Depression Scale (HADS)
  • Spiritual Well-Being Scale
  • Social Support Scale

Results

No significant difference was seen in anxiety and depression between the control and intervention groups after one week of palliative care. Improvement was seen in edema, fatigue, dry mouth, and abdominal distention.

Conclusions

Nurse interventions improved symptom management for the intervention group; however, in the short timeframe of this study emotional disturbances were not affected. Cultural implications are important here; death is a taboo topic in Chinese culture, and patients' understanding of their terminal disease is low and rarely discussed.

Limitations

  • Small sample (< 100)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • Patients were given the choice of usual care plus visits from the palliative care team versus usual care alone. The timeframe was only one week, and the number of visits and disciplines of the palliative care team were not clearly described. Nurse interventions for some physical symptoms are described very generally; no interventions for depression or anxiety are described.

Nursing Implications

Palliative care consultation may benefit many symptoms of patients with cancer, but without clear interventions for depression and in this short timespan, little effect is apparent.

Print

Liao, M.N., Chen, P.L., Chen, M.F., & Chen, S.C. (2010). Effect of supportive care on the anxiety of women with suspected breast cancer. Journal of Advanced Nursing, 66, 49–59.

Study Purpose

To test the hypothesis that women with suspected breast cancer who received a supportive care intervention during the diagnostic phase of care would have lower anxiety than those having usual care

Intervention Characteristics/Basic Study Process

The intervention was supportive care, emotional support, and educational information provided by nurses through three individual meetings and two telephone calls.

Sample Characteristics

  • The study reported on a sample of 114 participants.
  • Mean participant age was 48.1 years.
  • The sample was 100% female.
  • All participants had a breast lump found through clinical examination or imaging that needed biopsy.
  • Most women had no history, experience, or family history of breast disease.
  • Most women had an education level of high school completion or beyond, were married or lived with partners, and had family or friends with whom to talk.

Setting

  • Single site
  • Outpatient setting
  • Taiwan

Phase of Care and Clinical Applications

Patients were undergoing the diagnostic phase of care.

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

State-Trait Anxiety Inventory (STAI)

Results

Women in the intervention group had significantly lower state anxiety before biopsy and after learning the result compared to the control group (p = 0.008; p = 0.001).

Conclusions

Women with suspected breast cancer who received the supportive care program had lower anxiety than those receiving routine care.

Limitations

  • The study had no attentional control.
  • Subjects in the experimental group received more time and attention than those in the control group, so the impact of the actual supportive program design versus the impact of just increased attention cannot be determined.
  • Participants were not blinded to group assignment, which could have biased self-report results on the STAI.

Nursing Implications

Though resulting differences between groups were statistically significant, differences in scores between groups ranged from 1.14 to 2.12 on average, in a possible 80-point scale. The clinical relevance of this small difference is questionable, and the level of anxiety indicated by scores was still severe.

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Ludwig, G., Krenz, S., Zdrojewski, C., Bot, M., Rousselle, I., Stagno, D., . . . Stiefel, F. (2014). Psychodynamic interventions in cancer care I: Psychometric results of a randomized controlled trial. Psycho-Oncology, 23, 65–74. 

Study Purpose

To evaluate the effects of a psychodynamic-oriented intervention in patients with cancer

Intervention Characteristics/Basic Study Process

Patients who consented were randomized to an immediate intervention group or a waitlist controlled group. Patients who did not want to participate were assigned to an observation group, and they agreed to complete study measurements. The intervention involved an immediate phase of four sessions during which the therapist aimed to link the patients’ biographical information with current responses to disease. The authors noted that this intervention was not considered psychotherapy, but it was designed as psychological support. After the initial sessions, subjects were able to participate in 12 additional sessions if they chose to. Study questionnaires were completed by patients in the home at baseline and at four, eight, and 12 months.

Sample Characteristics

  • N = 191 (99 in observation group)
  • MEAN AGE = 53.2 years (SD = 11.6 years)
  • MALES: 34.7%, FEMALES: 65.3%
  • KEY DISEASE CHARACTERISTICS: Various cancer types including breast, gastrointestinal, urogenital, respiratory, and hematologic among others
  • OTHER KEY SAMPLE CHARACTERISTICS: 32% of patients were receiving psychotropic medications. Baseline anxiety and depression scores were low (below clinically relevant levels). Patients with schizophrenia, major depression, or severe psychiatric illnesses were excluded.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
  • Symptom checklist
  • Toronto Alexithymia Scale (TAS)

Results

Only four patients in the immediate intervention group demonstrated improvements in ​total HADS scores (defined as a 50% improvement in score). Only 31.5% of those initially entered in the study had data for follow-ups, and the number of drop-outs in the waitlist controlled group was higher. There were no significant differences in study outcome measures between groups, and at some time points, control group scores were better. Only 50% of participants were interested in additional sessions of the intervention.

Conclusions

This study did not show any effects for the tested intervention. Multiple study flaws could have contributed to these results.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Questionable protocol fidelity
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: There were significant differences in age, use of psychotropic medication, and study measurement scores between the groups at baseline with the intervention group being older with a larger proportion of participants taking medications. Baseline HADS scores were low, suggesting a potential floor effect with study measures. A few patients in the control group requested the intervention and were then added to the intervention group rather than eliminated from the study analysis. There were huge drop-out rates, a lot of missing data, and no ITT analysis. The authors noted that a large number of patients who were approached declined participation. This, along with the large number of drop-outs, suggests that this type of intervention may not be practical or acceptable to patients. It was noted that patients receiving cancer treatment living in rural areas had difficulty participating.

Nursing Implications

This study did not show any effects of the supportive psychodynamic intervention examined. These results need to be viewed with caution because of the multiple flaws and limitations of the study. This report points to the difficulty of getting sustained patient participation in this type of therapy or research. It is not clear if drop-outs were caused by competing issues such as transportation for sessions, problems encountered during cancer treatment, a lack of patient interest, or sense of benefit. Supportive interventions for patients with cancer need to be practical in their implementation for both providers and patients.

Print

Miller, D.K., Chibnall, J.T., Videen, S.D., & Duckro, P.N. (2005). Supportive-affective group experience for persons with life-threatening illness: Reducing spiritual, psychological, and death-related distress in dying patients. Journal of Palliative Medicine, 8, 333–343.

Intervention Characteristics/Basic Study Process

The intervention was a 75-minute supportive-affective group that met monthly offering Life-Threatening Illness Supportive-Affective Group Experience (LTI-SAGE). These groups were for education and support, not group therapy. Topics included

  • Group dynamics and expectations
  • Recognizing and asserting needs
  • Feelings and emotions
  • Symptom control
  • Living well while ill
  • Intimate relationships
  • Spiritual needs
  • Asking for help
  • End-of-life care planning/decision making
  • Legacy
  • Hope
  • Group closure.

Groups consisted of three to eight patients, with one or two group facilitators.

Two measurements were taken: baseline and 12 months

In the intervention group (n = 37), group assignment was based on diagnosis and race.

In the control group (n = 32), patients received quarterly mailings of existing, readily available self-help resource materials, with a phone call to ensure that mailings were received.

Sample Characteristics

The study reported on a sample of 69 African American and Caucasian patients with any serious medical condition severe enough to create a limited life expectancy (not cause death within six months).

Study Design

The study was a randomized pre/post-test trial with a longitudinal design.

Measurement Instruments/Methods

  • Beck Depression Inventory
  • State-Trait Anxiety Inventory (STAI)
  • Death Distress Scale
  • Spiritual Well-Being Scale
  • Illness Disability Index
  • Perceived Social Support Inventory
  • Analysis of covariance
  • Statistics done in two ways: intent-to-treat basis (with the seven noncompliant patients) and also with the seven noncompliant patients removed from the intervention group

Results

  • In the intervention group, 7 patients attended 3/12 groups and 21 patients attended 9/12 groups.
  • There were no significant statistical differences between groups in anxiety levels. The intervention group did enjoy reduced depression, increased spiritual well-being, and reduced death-related feelings of meaninglessness; p level set at 0.10.
  • STAI stats: t(40) = 0.8 with p value 0.40 at baseline
  • SSAI postintervention: p = 0.70

Limitations

  • The study had a small sample size.
  • Not all patients were diagnosed with cancer.
  • The intervention required specially trained facilitators to teach groups.
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Obadina, E.T., Dubenske, L.L., McDowell, H.E., Atwood, A.K., Mayer, D.K., Woods, R.W., . . . Burnside, E.S. (2014). Online support: Impact on anxiety in women who experience an abnormal screening mammogram. Breast, 23, 743–748. 

Study Purpose

To evaluate the impact of a computer- and web-based tool on the anxiety of women who had an abnormal mammogram.

Intervention Characteristics/Basic Study Process

Patients were randomized in to a study group and comparison group. The study group received an email with instruction for using the Comprehensive Health Enhancement Support System (CHESS). The comparison group received a list of five credible breast imaging websites. Impact of CHESS evaluated anxiety and breast cancer worry and patient satisfaction with their physician interaction at three time points.

Sample Characteristics

  • N = 130  
  • AGE: Older than aged 21 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Recalled after a screening mammography
  • OTHER KEY SAMPLE CHARACTERISTICS: English literate; access to Internet

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: University of Wisconsin Breast Center

Phase of Care and Clinical Applications

  • PHASE OF CARE: Diagnostic
  • APPLICATIONS: Elder care

Study Design

Pilot study; randomized intervention and comparison group

Measurement Instruments/Methods

  • State anxiety (SA) subscale of the State-Trait Anxiety Inventory (STAI)
  • The breast cancer worry subscale of the Lerman Breast Cancer Worry Scale (LBCWS)
  • Patient Satisfaction with Doctor Questionnaire (PSQ-MD)

Results

There was a significant difference in the anxiety scores for the intervention group at the biopsy stage (p = 0.02). There was no difference in the two groups at the diagnostic phase. There was no significant difference in the two groups for breast cancer worry.  Satisfaction with the physician was not analyzed because study participants had difficulty identifying who their physician was during the three time points.

Conclusions

Early CHESS may decrease anxiety in woman recalled for abnormal mammograms when combined with an identifiable care team.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)  
  • Risk of bias (sample characteristics)
  • Measurement/methods not well described

 

Nursing Implications

Providing resources to women with abnormal mammograms is most effective when a healthcare team interaction is provided to reduce anxiety. Online support system may have some benefit but additional research is needed to determine effectiveness for anxiety and other symptoms, and long-term efficacy needs to be examined.

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Steinhauser, K.E., Alexander, S., Olsen, M.K., Stechuchak, K.M., Zervakis, J., Ammarell, N., . . . Tulsky, J.A. (2017). Addressing patient emotional and existential needs during serious illness: Results of the Outlook randomized controlled trial. Journal of Pain and Symptom Management, 54, 898–908.

Study Purpose

To evaluate outlook, an intervention to assist patients address emotional and existential needs, in people living with advanced disease yet not in the final months of life. If improvements were demonstrated, it could improve understanding of intervention in early versus late palliative care contexts.

Intervention Characteristics/Basic Study Process

Three-arm randomized controlled trial testing the effect of Outlook, with an attention control (RM) and a true control (usual care UC). Baseline interview completed in person or on the phone, then randomized 1:1:1. Participants assigned to Outlook were interviewed in person three times during a one-month period after the baseline interview. Session 1 was life review; session 2 was issues of forgiveness, regret, things left unsaid, or undone; and session 3 was heritage and legacy. Interviews were a week apart and lasted 45 minutes. Participants assigned to RM met with the interventionist in person three times during a one-month period and listed to a relaxation CD for 40 minutes. UC participants were not contacted. Interventionists were clinical social workers trained in delivering standardized interventions following a manualized script. Sessions were audio recorded.

Sample Characteristics

  • N = 221   
  • AGE: Mean = 67.8 years
  • MALES: 96%  
  • FEMALES: 4%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Advanced cancer, congestive heart failure, chronic obstructive pulmonary disease, end-stage renal disease, end-stage liver disease
  • OTHER KEY SAMPLE CHARACTERISTICS: Non-hospice eligible, veterans

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Durham, North Carolina

Phase of Care and Clinical Applications

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

Study Design

Three-arm randomized controlled trial testing the effect of Outlook compared with an attention control (relaxation meditation [RM]) and a true control (usual care [UC]) on patient QOL, functional status, and emotional well-being.

Measurement Instruments/Methods

Primary outcomes:

  • Preparation and completion: QUAL-E a 31-item validated measure of QOL at the end of life

Secondary outcomes:

  • Anxiety: Brief Profile of Mood States
  • Depression: Center for Epidemiological Studies-Depression scale
  • Quality of Life: FACT-General FACT
  • Spiritual Well Being: Functional Assessment of Chronic Illness Therapy-spiritual well-being.

Results

The study compared change in primary and secondary outcomes over time between outlook and both the RM and UC groups. Outlook participants had higher improvements in mean preparation (p = 0.02) and mean completion (p = 0.04) at five week follow-up compared with UC. The differences did not persist for the seven week follow-up. Compared to the RM group, Outlook participants did not have a significant difference in preparation and completion at either follow up. Outlook social well-being was improved over RM at the seven-week follow-up. Outlook did not show significant difference over time in QOL, anxiety, or depression. Qualitative interview participants (15%) described Outlook at helpful. Participants valued the opportunity to review life memories as a source of strength and to identify unresolved issues.

Conclusions

Outlook did not demonstrate sustained improvements in preparation, anxiety, or depression and overall QOL compared to RM in adults with advanced illness who were not hospice eligible. Outlook as an intervention was positive for patient quality of life in reviewing memories as a source of strength, and releasing unresolved emotions and concerns.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no appropriate attentional control condition)  
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results

 

Nursing Implications

The structured Outlook intervention which assists patients to review and resolve important life issues and concerns is valuable for patients with terminal illness, including patients with cancer. Nurses can assess patients for distress and ensure that opportunities and referrals with support resources are explored. This would be relevant to the hospice setting.

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White, V.M., Macvean, M.L., Grogan, S., D'Este, C., Akkerman, D., Ieropoli, S., . . . Sanson-Fisher, R. (2012). Can a tailored telephone intervention delivered by volunteers reduce the supportive care needs, anxiety and depression of people with colorectal cancer? A randomised controlled trial. Psycho-Oncology, 21, 1053–1062.

Study Purpose

To assess the effectiveness of a volunteer-delivered, tailored telephone-based intervention in reducing unmet supportive care needs and elevated levels of anxiety and depression among people with colorectal cancer

Intervention Characteristics/Basic Study Process

The intervention utilized a checklist of unmet needs that patients with colorectal cancer completed. Specially trained volunteers then followed up with patients, by means of telephone consultation, to review needs and devise an action plan.

Sample Characteristics

  • The study reported on a sample of 653 patients with colorectal cancer.
  • Mean patient age was 64.57 years (SD = 9.2 years).
  • The sample was 40.5% female and 59.5% male.
  • Of sample patients, 78% were married; 49% had undergone chemotherapy, 89% had undergone surgery, and 10% had undergone radiotherapy; and almost 90% had at least a high school education.

Setting

  • Outpatient setting
  • Australia

Phase of Care and Clinical Applications

Transition phase of care

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • Supportive Care Need Survey (SCNS)
  • Hospital Anxiety and Depression Scale (HADS)
  • Nine-item colorectal cancer symptom checklist (developed for study)
  • Eleven-item questionnaire on the use of supportive care services (developed for study)
  • Medical Outcome Study Social Support Survey (MOS-SSS)

Results

  • The prevalence of elevated anxiety decreased over time in the intervention group (p < 0.01).
  • Compared to the control group, the intervention group reported a greater use of services (p < 0.01).

Conclusions

This study suggests that a volunteer-delivered, telephone-based intervention is plausible and acceptable to patients with cancer and that the intervention was effective in getting patients to use available services. This approach was associated with reduced anxiety over time, but did not have an impact on depression or prevalence of unmet needs as identified by the patients.

Limitations

  • The study design lacked an attentional control.
  • The study did not include discussion regarding supportive services utilized and whether they met patients’ unmet needs.
  • The intervention was delivered to patients three to four months postdiagnosis, and the highest period of unmet needs may actually be sooner in the treatment trajectory.

Nursing Implications

Tailoring support and interventions to only those patients with unmet needs might be a better allocation of resources while producing significant results.

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White, V.M., Young, M., Farrelly, A., Meiser, B., Jefford, M., Williamson, E., . . . Winship, I. (2014). Randomized controlled trial of a telephone-based peer-support program for women carrying a BRCA1 or BRCA2 mutation: Impact on psychological distress. Journal of Clinical Oncology, 32, 4073–4080.

Study Purpose

To determine if peer telephone intervention would reduce distress among women with BRCA1/2.

Intervention Characteristics/Basic Study Process

Recruitment through familial cancer clinics; baseline questionnaire completed and then those who indicated interest in talking with a peer were randomly assigned to the intervention group (IG) or usual care group. Those in the IG received surveys four and six months after baseline. IG matched with peer to support. Peers were recruited and received a program manual and three days of training. Contact between peer and participant was to occur six times in a four-month period.

Sample Characteristics

  • N = 174
  • MEAN AGE: 43.56 for the IG and 43.18 for controls
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Women; BCRA1/2 mutation carriers; received genetic counseling
  • OTHER KEY SAMPLE CHARACTERISTICS: No advanced cancer; within five years of knowing genetic status; older than age 18 years

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

  • Single blind randomized, controlled trial

Measurement Instruments/Methods

Baseline questionnaires for socioeconomic information, cancer history and treatment, family history of cancer, age when notified of mutation status, BRCA1/2 mutation status of female relatives, risk-reducing surgeries, screening behaviors, and supportive care services used. At time 2, peer satisfaction was asked; Impact of Event Scale (IES) measuring distress; a single item question for anxiety; 16-item scale to measure unmet needs. 10-item cognitive appraisals about genetic testing scale.

Results

There was little change in the mean scores on most outcome measures during the three time points. Unmet needs was the only outcome measure that decreased consistently over time. Breast cancer distress (IES) showed a significantly lower level of stress in the IG (p < 0.01). Anxiousness and stress were  lower in the IG at the first two time points (p < 0.03), but there was no difference after that. Telephone based intervention reduced distress and unmet information needs for this group. Percent of patients contacted continued to decline over time, and by the sixth phone call less than 25% had any contact.

Conclusions

Peer support programs may be effective at reducing distress and anxiety in those who are BRCA1/2 carriers.

Limitations

  • Risk of bias (no appropriate attentional control condition)
  • Measurement validity/reliability questionable
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals of 10% or greater 
  • Other limitations/explanation: Usual care is not well defined; family members in the IG were not assigned to the same peer. A high percentage of the intervention group did not have actual contact after the third call, suggesting that the duration of the intervention was not practical or accepted. Those who dropped out had higher baseline stress scores. A single-item scale was used for measurement of anxiety.

Nursing Implications

Peer support among women with genetic mutations may prove to reduce distress. This type of support may be beneficial for other patient populations. Findings from this study suggest that the greatest needs and efficacy may be in the short term, since many patients did not have contact after the third phone call. As anxiety tends to decline over time, it is unclear from this study what the actual efficacy was for anxiety.

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