Psychoeducation/Psychoeducational Interventions

Psychoeducation/Psychoeducational Interventions

PEP Topic 
Chronic Pain
Description 

Psychoeducation, or psychoeducational interventions, combine education and a broad range of other activities, such as counseling and supportive interventions. Psychoeducation 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 booklets, videos, audiotapes, and computers; formats may be interactive and involve healthcare professionals, patients, and caregivers. Patients may deliver psychoeducational CDs and online materials to themselves. Professionals may deliver other information telephonically. Studies of psychoeducational interventions tend to vary substantially in regard to specific content, format, frequency, and intervention timing. For this reason, the ability to examine the relative effectiveness of different formats and delivery methods is limited. Resources identify highly specific content approaches—such as mindfulness-based stress reduction and cognitive behavioral approaches—as separate interventions rather than as components of psychoeducation.

Likely to Be Effective

Systematic Review/Meta-Analysis

Adam, R., Bond, C., & Murchie, P. (2015). Educational interventions for cancer pain. A systematic review of systematic reviews with nested narrative review of randomized controlled trials. Patient Education and Counseling, 98, 269–282. 

doi: 10.1016/j.pec.2014.11.003
Print

Purpose:

STUDY PURPOSE: To review the evidence for educational interventions in cancer-related pain management

TYPE OF STUDY: Systematic review

Search Strategy:

DATABASES USED: MEDLINE, EMBASE, CINAHL, and Cochrane collaboration
 
KEYWORDS: Cancer, education, and pain
 
INCLUSION CRITERIA: Systematic reviews that evaluated educational interventions for cancer pain management; participants were adult patients, caregivers, or health professionals
 
EXCLUSION CRITERIA: Studies including trials of cognitive behavioral therapy, mindfulness, relaxation, hypnosis, or acupuncture

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: 2,066
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist for quality assessment

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 8
  • TOTAL PATIENTS INCLUDED IN REVIEW = 18,544 (147 total studies)
  • KEY SAMPLE CHARACTERISTICS: Not provided

Phase of Care and Clinical Applications:

APPLICATIONS: Palliative care

Results:

In the eight systematic reviews included, two reported that educational interventions had a positive impact on pain intensity. The rest did not report any effects on pain outcomes but concluded improved knowledge and adherence to pain medications. A detailed review of randomized, controlled trials included in the systematic reviews reported improved pain intensity outcomes in 12 studies and no significant difference from controls in 18 studies. Educational interventions had at least one of the following components: education on the physiology of cancer-related pain, advice on how to report and communicate pain, enhancements of provider assessments of pain, improved analgesic prescribing, approaches to barriers to nonadherence, nonpharmacologic strategies, or the promotion of pain reassessment.

Conclusions:

Educational interventions for healthcare providers improved knowledge and attitudes, but their effects on patient pain outcomes were not demonstrated. Education for patients has shown inconsistent effects on pain outcomes. The key characteristics of effective educational interventions were not clear. Educational interventions for patients improved their knowledge and self-reported pain outcomes.

Limitations:

  • The studies included had very different scope and approaches.
  • The interventions were heterogeneous in approach, content, timing, and duration.

Nursing Implications:

Evidence regarding the effectiveness of educational and psychoeducational interventions to reduce cancer-related pain outcomes showed mixed results. However, in some studies, education had a positive effect on pain intensity. These interventions improved knowledge. Educational interventions are low-risk and can empower patients to self-manage pain. Evidence in this review suggested that ongoing patient contact and reinforcement is needed to maintain any gains from educational interventions. The most effective components and method of education delivery are not clear. This area could benefit from additional research.

Agboola, S.O., Ju, W., Elfiky, A., Kvedar, J.C., & Jethwani, K. (2015). The effect of technology-based interventions on pain, depression, and quality of life in patients with cancer: A systematic review of randomized controlled trials. Journal of Medical Internet Research, 17, e65. 

doi: 10.2196/jmir.4009
Print

Purpose:

STUDY PURPOSE: To review randomized, controlled trials evaluating the effect of telehealth interventions on pain, depression, and health-related quality of life outcomes in cancer care
 
TYPE OF STUDY: Systematic review

Search Strategy:

DATABASES USED: PubMed, EMBASE, Google Scholar, CINAHL, and PsychINFO
 
KEYWORDS: Neoplasms, cancer remote consultation, mHealth, connected health, text messaging, telemedicine, telehealth, ehealth, telephone therapy, teleconsultation, mobile technology, telecare, internet, digital health, mobile phone, smartphone, apps, and mobile application
 
INCLUSION CRITERIA: Reported the effect of telehealth on pain, depression, or quality of life in patients with cancer; randomized, controlled trials
 
EXCLUSION CRITERIA: Not stated

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: 4,929
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane Collaboration’s risk of bias tool 

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 20 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 3,654
  • SAMPLE RANGE ACROSS STUDIES: 25–571 patients 
  • KEY SAMPLE CHARACTERISTICS: Patients with cancer, access to telehealth, and smart phones; English-speaking; high-income countries; most were studies of patients with breast cancer

Phase of Care and Clinical Applications:

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

Results:

Many of the included studies were telephone-based interventions with the interventions provided by professionals or peer counselors. Five studies used a web-based delivery of the intervention. The duration of the interventions ranged from one week to 12 months with a median of 12 weeks. Three studies examined the effect on pain; two of these showed a significant positive effect of the intervention, and one showed no difference between the groups. Nine studies examined the intervention effect on depression; four of these showed positive effect on depression while five showed no significant effect. Eight studies examined quality of life, and one measured well-being.

Conclusions:

This review showed mixed results for the effects of technology-based interventions on pain and depression among patients with cancer.

Limitations:

There were few included studies, and most of them were done in high-income populations that were tech-savvy. There was high heterogeneity in the outcomes. Many of the studies had a high or unclear risk of bias.

Nursing Implications:

It may be worthwhile to use telehealth applications with tech-savvy, high-income patients. These types of interventions are worthy of additional study to fully determine the efficacy of these interventions for symptom management.

Bennett, M.I., Bagnall, A.M., & Jose Closs, S. (2009). How effective are patient-based educational interventions in the management of cancer pain? Systematic review and meta-analysis. Pain, 143(3), 192–199. 

doi: 10.1016/j.pain.2009.01.016
Print

Purpose:

To quantify and compare the benefits of various patient-based educational interventions for cancer pain management; to improve understanding of the relationship between education and improved pain outcomes

Search Strategy:

  • Databases searched were MEDLINE, CINAHL, EMBASE, Applied Social Sciences Index and Abstracts (ASSIA), Allied and Complementary Medicine Database (AMED), and PsycINFO from inception to Nov. 30, 2007, and the Cochrane Library; Database of Abstracts of Reviews of Effects (DARE) and National Institute for Health and Clinical Excellence (NICE) websites; and contents lists of Pain, Journal of Clinical Oncology and Journal of Patient Education and Counseling. In addition, investigators completed manual searches of article reference lists.
  • Authors did not include a list of search keywords.
  • Studies were included in the review if they
    • Incorporated experimental designs that included a control group.
    • Involved adults with pain from active cancer.
    • Used a patient-based educational intervention on an individual basis.
    • Assessed pain-related outcomes.
  • Studies were excluded if they dealt with pain from cancer treatment, such as surgery or chemotherapy.

Literature Evaluated:

The search retrieved 61 studies. Authors chose 21 studies for analysis. Twelve studies included pain-outcome data suitable for meta-analysis. Authors used the Cochrane Collaboration recommendations for randomized controlled trials as the basis of study evaluation. Studies were done in six different countries.

Sample Characteristics:

  • The sample was composed of 3,501 patients. The sample range across studies was 30–1,256.
  • Authors did not provide sample characteristics but did state that samples were composed predominantly of females and individuals who were recently diagnosed with a good performance status.

Results:

  • Analysis of Brief Pain Inventory (BPI) measures only showed significant effects of education on average pain intensity (p = 0.002), maximum pain intensity (p = 0.0004), least pain (p = 0.006), and current pain.
  • Effects of patient education on patient knowledge differed according to the scale of measurement. Significant outcomes resulted from the BPI questionnaire and the Pain Experience Scale only.
  • Across all studies, authors noted a significant effect on patient knowledge (p = 0.008). Compared to multiple exposures to patient education, single exposure had clearer benefits on knowledge and attitudes and similar effects on maximum pain intensity.
  • Effects of knowledge on average pain intensity were inconsistent. Effects on all outcomes were greater when intervention was compared to usual care rather than a placebo group or attentional control.
  • Education had no effect on the extent to which pain interfered in daily activities.
  • Data showed heterogeneity that authors could not explain, although they noted that in some cases heterogeneity seemed to be associated with measurement type.
  • Length of follow-up and the nature of the education varied across studies; therefore, authors could not analyze these factors separately.
  • Overall weighted mean difference regarding reduction in pain intensity was 0.76.

Conclusions:

Findings demonstrate that patient-based educational interventions for cancer pain improve knowledge and attitudes and can reduce pain intensity. The fact that effects were greater in studies with no attentional control raises the question of the benefits of attention itself. Authors observed that benefits were associated with both single- and multiple-exposure studies. Authors pointed out that the weighted mean difference in pain intensity, with educational interventions, was as large as that reported in another analysis for some types of co-analgesic therapies. This finding supports the clinical relevance of providing patient education.

Nursing Implications:

Most of this research was done early in cancer care and may not be directly applicable to patients in later phases of care. Additional research, with long-term follow-up and other patient groups, is needed.

Devine, E.C. (2003). Meta-analysis of the effect of psychoeducational interventions on pain in adults with cancer. Oncology Nursing Forum, 30(1), 75–89.

doi: 10.1188/03.ONF.75-89
Print

Purpose:

To obtain estimates of the effect of selected psychoeducational interventions on pain in patients with cancer

Search Strategy:

  • Databases searched were PubMed, CINAHL, Dissertation Abstracts, PsycLIT, and the Cochrane Database of Systematic Reviews.
  • Keywords searched were cancer, neoplasms, patient education, counseling, behavioral therapy, guided imagery, hypnosis, relaxation therapy, music, and pain.
  • Studies were included if they
    • Were experimental, quasi-experimental, or employed a pre/post-test single-group design.
    • Included outcome measurement for which an effect size could be calculated.
  • Studies were excluded if they compared psychoeducational therapy to pharmacologic treatment for pain, involved fewer than five subjects in each treatment condition, and included treatment and control groups from different settings.

Literature Evaluated:

The search retrieved 50 studies. Authors eliminated 25 studies on the basis of inclusion and exclusion criteria. Authors did not describe the method of evaluation.

Sample Characteristics:

  • Across all studies, the sample included 1,354 patients with various types of cancer. The sample range was 7–206 patients.
  • Authors included 25 studies in meta-analysis. 

Results:

  • Types of interventions: Interventions included listening to music, hypnosis, progressive muscle relaxation and imagery, cognitive-behavioral counseling, distraction, and support groups.
  • Effects on pain:
    • Relaxation, guided imagery music, or hypnosis interventions: Twelve studies used an intervention of this type, demonstrating an average weighted effect size of 0.65 (p < 0.05).
    • Education interventions: Six studies included this type of intervention.  Overall average effect size was 0.36 (p < 0.05).
    • Support plus other content: Five studies were included in this group.  Average effect size was 0.44 (p < 0.05).
    • Relaxation plus other content: Six studies showed an effect size of 0.07.

Conclusions:

Most studies demonstrated that psychoeducational interventions had at least a small positive effect on pain in patients with cancer.

Limitations:

  • This analysis included a broad variety of interventions, a fact that raises questions about the generalizability of conclusions from the analysis.
  • Authors identified a number of methodologic and reporting issues, which raises concerns about the validity and utility of study findings.
  • Several studies had very small sample sizes and reported very high attrition rates.
  • Differences among educational interventions, cognitive behavioral therapy interventions, and usual care are unclear.
  • Most of the education studied in this research was aimed at enhancing patient use of prescribed analgesic regimens.

Nursing Implications:

Further well-designed research in this area is needed. The complexity of cancer-related pain presents a number of challenges inherent in this research; authors outline these challenges. Psychoeducational interventions may be more acceptable to some patients than others, as high attrition rates suggest. In addition, rating pain is a subjective activity. The efficacy of an intervention may differ with cancer phase and with different pain severity. These factors should affect selection of intervention type.

Flemming, K. (2010). The use of morphine to treat cancer-related pain: A synthesis of quantitative and qualitative research. Journal of Pain and Symptom Management, 39(1), 139–154. 

doi: 10.1016/j.jpainsymman.2009.05.014
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Purpose:

  • To examine the context of the use of morphine to manage cancer-related pain
  • To establish how the views of healthcare professionals, patients, caregivers, and prescribers affect the use of morphine in practice
  • To provide a case study and critique of critical interpretive synthesis (CIS) to synthesize a diverse body of evidence

Search Strategy:

  • Databases searched were MEDLINE on OvidSP (1950–2008), CINAHL (1982–2008), EMBASE (1980–2008), PsycINFO (1967–2008), Health Management Information Consortium, and Social Sciences Citation Index accessed via Web of Science (1956–2008).
  • Authors designed a search strategy that combined recognized search terms related to morphine (predominantly, terms used by the Cochrane Pain, Palliative and Supportive Care Group for oral morphine for cancer pain) with terms to identify qualitative research. Authors supplemented electronic searching with manual searches and contact with experts.
  • Studies were included if they
    • Described results of original qualitative research.
    • Referred to the use of opioids for cancer pain.
    • Were published in English.
  • Authors did not cite exclusion criteria.

Literature Evaluated:

Electronic searches retrieved a total of 2,886 records. After screening by title, 255 abstracts were retrieved for initial review. Of these the author obtained 30 articles for full review. Reference chaining yielded another 10 articles. A final sample of 19 resources met criteria and were analyzed. The author used a quality-appraisal checklist. Findings from each qualitative report were identified and compared with recommendations regarding effectiveness. Two resources provided the framework of comparison: Cochrane Systematic Review of Oral Morphine for Cancer Pain and the European Association for Palliative Care recommendations regarding use of opioids for cancer pain.

Sample Characteristics:

  • The sample, across studies, included 465 patients.
  • Study samples included male and female patients and self-identified African Americans.
  • Samples included caregivers, nurses, patient and caregiver triads, and nursing and medical students. Patients included those who adhered and did not adhere to prescribed regimens, reluctant opioid takers, and older individuals in the community.

Results:

The study resulted in the synthesis of four arguments.

  • Concerns about opiods:
    • Morphine was the drug of choice.
    • Patients, caregivers, and professionals had deep concerns about starting and continuing morphine therapy. The introduction of morphine was perceived as an accompaniment to worsening disease and death—a last resort.
    • The addictive potential of morphine was a barrier to its use, and anxieties about addiction influenced patients, caregivers, healthcare professionals, and medical and nursing students.
  • Opioid use as a balancing act and trade-off:
    • Patients grappled with wanting pain relief while wanting to maintain functionality in their lives. They thought that, if they took opioids to relieve pain, they could experience adverse effects.
    • Adverse effects were viewed as a burden and were either tolerated to achieve relief or avoided by not taking medication.
    • The adverse effect most frequently mentioned was mental clouding and sleepiness.
    • After pain was so severe that taking opioids was the only alternative, the trade-off with side effects became acceptable. This was often when death was imminent. In many cases, patients took the opioids out of concern for others who were witnessing their pain.
  • Existential meaning of cancer and cancer pain: Patients identified the meanings that follow.
    • Severe pain negated patients’ will to live.
    • Pain was a reminder of the presence of the cancer.
    • Severe pain indicated worsening disease and impending death.
    • Pain was vicious and exceeded any sense of control.
    • Patients feared that pain would increase before death.
    • Pain was tied up with all the emotions, fears, and uncertainties about the cancer diagnosis.
    • Taking opioids meant the cancer was out of control.
    • Fear of pain with dying was greater than the fear of dying itself.
    • Death would be a release from pain.
    • Cancer pain is a personal and private experience that no one else can understand.
  • Intersubjectivity of pain: Cancer pain affects more than just the person experiencing it; it affects health professionals, caregivers, and the patient. Themes in this area follow.
    • Role and influence of health professionals:
      • Fears and concerns about addiction and adverse effects were implicitly or explicitly communicated to patients.
      • Teamwork involving nurses, physicians, patients, and caregivers was crucial to effective pain management.
    • Role of caregivers:
      • Feelings of conflict over how much control to assume in managing analgesia and how much control to give to nurses and the patient.
      • Dose-juggling responsibilities.
      • Despite education, caregivers were skeptical about problems of addiction.
      • They experienced fear, suffering, and helplessness and futility in the setting of unrelieved pain.
    • Management of pain by the patient:
      • Patients described a parallel existence—striving to live while strategizing to have a comfortable death.
      • Use of regular analgesia did not fit with some individuals’ self-image and led to conflict and guilt.
      • Various physical and cognitive strategies to manage pain were used. Most involved input from caregivers. This was a positive benefit for both.

Patients were selective about their disclosure of pain severity. The degree of confidence and trust in providers influenced reporting about pain, treatment choices, and use of opioids. Negative feeling toward providers led to reluctance to report pain.

Conclusions:

This review provides a wealth of powerful and meaningful information that healthcare professionals can use to improve how they work with patients and caregivers in the management of cancer-related pain. Findings suggest that many professionals still have concerns about addiction with the use of opioids in the treatment of chronic cancer pain and that these professionals intentionally or unintentionally communicate these concerns, adversely influencing patients' and caregivers' experiences. Findings point to the importance of aggressive management and prevention of adverse side effects from opioids, to have a positive effect on the patient’s sense of the trade-offs involved with opioids. Findings support the concept that a team approach involving providers, caregivers, and patients and trust among team members are crucial to effective pain management.

Nursing Implications:

Nurses can use the themes to guide open discussion and to anticipate potential issues regarding the use of opioids for pain management.

 

Jho, H.J., Myung, S.K., Chang, Y.J., Kim, D.H., & Ko, D.H. (2013). Efficacy of pain education in cancer patients: A meta-analysis of randomized controlled trials. Supportive Care in Cancer, 21, 1963–1971.

doi: 10.1007/s00520-013-1756-0
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Purpose:

STUDY PURPOSE: To evaluate the overall efficacy of pain education among patients with cancer by using a meta-analysis of randomized controlled trials (RCTs)

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy:

DATABASES USED: PubMed, EMBASE, Cochrane Library

KEYWORDS: cancer; pain; education; counseling

INCLUSION CRITERIA: RCTs that included patients with cancer with pain, used an education intervention for cancer pain management, and presented pain intensity at baseline and after intervention

EXCLUSION CRITERIA: Duplicated studies; same study in more than one publication

Literature Evaluated:

TOTAL REFERENCES RETRIEVED = 213 (36 thoroughly reviewed)

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two investigators independently reviewed and then compared discrepancies. Studies were rated on a 1–5 quality scale for RCT evaluation.

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 12
  • TOTAL PATIENTS INCLUDED IN REVIEW = 2,169 total patients; 1,069 patients enrolled in an intervention and 1,100 in a control arm
  • KEY SAMPLE CHARACTERISTICS: Mean age was 57.2 years; 59% women

Phase of Care and Clinical Applications:

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

Results:

  • Overall pain education for patients with cancer showed a small but insignificant effect (standardized mean difference -0.11).
  • Pain education was more effective in inpatients than outpatients.
  • Pain education was more effective within two weeks of a first follow-up.
  • A difference existed in the efficacy of the pain education based on pain intensity.
  • Pain education was effective when tailored to an individualized patient. No beneficial effect was observed in high-quality studies, but lower pain was found in low-quality studies.
  • Overall, insufficient evidence exists to support the use of pain education in patients with cancer.

Conclusions:

This study showed that overall pain education in patients with cancer showed a small efficacy on pain relief in the meta-analysis of these RCTs.

Limitations:

  • Authors note that many studies were not included because of lack of data.
  • Predictors of pain response were not evaluated (e.g., age, socioeconomic status, education).
  • Attention control inconsistent within the studies
  • Quality of life or distress of pain on the patient not examined

Nursing Implications:

Further studies are needed regarding the use of pain education on patients with cancer and the relation to pain relief. Because some patients benefited from the interventions, nurses may focus on situations in which patients received the most benefits (e.g., inpatients, patients with the most severe pain, education within the first two weeks of follow-up).

Johannsen, M., Farver, I., Beck, N., & Zachariae, R. (2013). The efficacy of psychosocial intervention for pain in breast cancer patients and survivors: A systematic review and meta-analysis. Breast Cancer Research and Treatment, 138, 675–690.

doi: 10.1007/s10549-013-2503-4
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Purpose:

STUDY PURPOSE: To systematically review and quantify research on the effect of psychosocial interventions on pain in patients with breast cancer

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy:

DATABASES USED: Cochrane, PubMed, PsycINFO, EMBASE, Web of Science

KEYWORDS: breast cancer; pain; cancer-related pain; intervention; psychosocial; yoga; mindfulness; meditation; hypnosis; psycho-education; therapy

INCLUSION CRITERIA: Data on a psychosocial intervention; baseline and post-intervention pain measures; data on breast cancer populations; quantitative research

EXCLUSION CRITERIA: Patients younger than 18 years; non-English speaking; non-peer reviewed

Literature Evaluated:

TOTAL REFERENCES RETRIEVED = 163

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Independently reviewed by two raters who disagreed on 13 (8.7%); 0.71 kappa statistic for inter-rater agreement

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 26
  • TOTAL PATIENTS INCLUDED IN REVIEW = 2,193 women; 1,786 in analysis
  • KEY SAMPLE CHARACTERISTICS: Patients with stage I–IV breast cancer; majority had completed treatment
     

Phase of Care and Clinical Applications:

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

Results:

Psychosocial interventions overall were found to be effective. Robust effect size was found (g = 0.37) [95% CI 0.2–0.4]) but was smaller (g = 0.21) when adjusted for publication bias. Patient education approaches yielded a larger effect (g = 0.64) than supportive group therapy (g = 0.17).

Conclusions:

Psychosocial interventions are effective in reducing pain in patients with breast cancer. Patient education and supportive group therapy appear to be the most effective interventions.

Limitations:

  • Quality of research papers varied.
  • Pain was not the primary outcome in most studies.

Nursing Implications:

Nurses should employ psychosocial interventions to help ameliorate pain in patients with breast cancer. Education and support group interventions should be used initially because they appear to yield the greatest benefit.

Koller, A., Miaskowski, C., De Geest, S., Opitz, O., & Spichiger, E. (2012). A systematic evaluation of content, structure, and efficacy of interventions to improve patients' self-management of cancer pain. Journal of Pain and Symptom Management, 44, 264–284.

doi: 10.1016/j.jpainsymman.2011.08.015
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Purpose:

To perform a systematic review to describe the structure and content of interventions to improve patients’ self-management of cancer pain; to report the efficacy of the various intervention components
 

Search Strategy:

  • Databases searched were MEDLINE, CINAHL, and the Cochrane Library (December 2007–November 2010).
  • Authors used the same search terms as Bennett, Bagnall, and Jose Closs (2008), whose publication said that details of the search were available upon request.
  • Studies were included if they
    • Were randomized controlled trials or controlled trials in which the control group received usual care or attention only.
    • Included adults with pain from active cancer and not pain from cancer treatment.
    • Used a patient-based educational intervention on an individual basis.
    • Assessed pain-related outcomes. 
  • Studies were excluded if they used psychobehavioral methods in the intervention.

Literature Evaluated:

The search retrieved 36 references. Authors used content analysis to reach consensus on the categorization of the interventions’ structure and content components. Components were categorized into seven structure components and 16 content components. Investigators calculated Hedges's g effect to determine between-group effects for each pain intensity measure at each time point. Studies with statistically significant findings were evaluated to determine patterns or trends associated with a specific structure or content component.

Sample Characteristics:

  • The final number of studies included was 34.
  • The sample range across studies included a total of 4,139 patients in 24 interventions. The number of patients in the 11 statistically significant studies was 1,041. The range of sample size was 30–1,256 patients.
  • The range of mean patient age was 48–77 years.
  • Of all patients, 57% were women and 43% were men.
  • Cancer diagnoses in the sample were primarily lung, breast, prostate, gastrointestinal, gynecologic, hematologic, and head and neck cancers.
  • The majority of studies (14) were conducted in the United States.

Phase of Care and Clinical Applications:

  • Phases of care: multiple
  • Clinical applications: elder care and palliative care

Results:

  • Structural components of the intervention included the factors that follow.
    • How the intervention was delivered.
    • What materials were given to patients.
    • Receiver and provider of the intervention.
    • Whether interactions took place between providers and receivers.
    • Level of individualization (structured or tailored) for each patient.
    • Contact time between clinicians and patients or family caregivers.
    • Timing of the intervention
  • The 16 content components of the intervention were divided into four categories:
    • Cognition.
    • Behavioral.
    • Goal setting.
    • Direct contact between research staff and clinicians.
  • Authors found no apparent patterns, for any single component or any combination of components, with statistically significant and clinically meaningful effects. This may be due to the lack of homogeneity in study designs and the variability of the structure and content components.
  • Other factors may play a role in an intervention's efficacy (e.g., provider’s empathy, setting of the intervention).
  • Spending more time with patients did not always result in increased knowledge or changes in patients’ behaviors. Similarly, multiple interventions did not always result in increased knowledge or behavior changes.
  • Optimal dose and timing of the intervention to improve cancer pain management are unknown.

Conclusions:

Although the efficacy of various intervention components could not be clearly delineated, this systematic review provides an overview of the various structural and content components of intervention studies to improve cancer pain management and an evaluation of combinations of components.

Limitations:

  • One limitation was the fact that authors included published studies only.
  • The number of studies included was small, which may have led to overestimation of effect sizes.

Nursing Implications:

Nurses need to be aware of the various structural and content components of interventions to support patients’ self-management of cancer pain. The interventions should be culturally appropriate and include written material; a face-to-face educational session of at least 15 minutes; and information about pain treatment, cognitive barriers to pain management, and implementation of self-management pain strategies.

Kwekkeboom, K. L., Cherwin, C. H., Lee, J. W., & Wanta, B. (2010). Mind-body treatments for the pain-fatigue-sleep disturbance symptom cluster in persons with cancer. Journal of Pain and Symptom Management, 39, 126–138.

doi: 10.1016/j.jpainsymman.2009.05.022
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Purpose:

To identify and synthesize the evidence for mind-body interventions for which the evidence suggests benefit for at least two of the three cluster symptoms of pain, fatigue, and sleep disturbance.

Search Strategy:

Databases searched were CINAHL, MEDLINE, and PsycINFO through March 2009.

Search keywords were guided imagery, hypnosis, relaxation, biofeedback, cognitive behavioral therapy, coping skills training, meditation, virtual reality, music AND cancer AND fatigue, sleep disturbance, sleep difficulty, insomnia, and pain.

Studies were included in the review if they

  • Were limited to research
  • Included adults aged 18 years and older
  • Included mind-body activities that involved primarily mental activity that could be performed by almost all patients
  • Included pain, fatigue, or sleep among study dependent variables.

Studies were excluded if they

  • Involved the use of yoga
  • Involved patients in whom a diagnosis of cancer was not yet established
  • Had a sample that included people without cancer.

Literature Evaluated:

A total of 47 studies were identified. In four of those, all testing virtual reality, only the symptom of fatigue was measured, so these were eliminated.

Sample Characteristics:

The final sample included 43 studies. Study sample sizes and total patients involved across studies were not reported.

Results:

Relaxation

Six studies examined relaxation interventions in hospitalized patients, outpatients with chronic pain, and women with early-stage breast cancer.

  • Significantly greater pain relief was obtained with progressive muscle relaxation compared to massage, usual treatment, mood manipulation, distraction, and controls.
  • One study found no difference in pain between a daily relaxation exercise and distraction.
  • Training in muscle relaxation did not improve fatigue in one study compared to provision of information.
  • In one study, muscle relaxation improved sleep compared to usual treatment controls.

Imagery and Hypnosis

Six studies examined imagery and hypnosis.

  • In four studies, imagery was used in hospitalized patients with cancer pain, and beneficial effects were reported.
  • One study found no differences in pain or fatigue between patients with an imagery intervention and those receiving standard care.
  • Four studies used imagery in comparison to cognitive-behavioral therapy (CBT) and combined imagery with relaxation. Of those, one study reported no significant effect, two reported significant pain reduction, and one reported significant reduction in fatigue and sleep disturbance.

Cognitive Behavioral Therapy (CBT)/Coping Skills Training (CST)

Twenty-one studies tested CBT/CST.

  • In three studies, fatigue was the primary focus. Significantly more improvement in fatigue was reported with a six- to 12-week CBT/CST intervention compared to usual treatment and controls.
  • Three studies evaluated CST effects on the combination of pain and fatigue. In all of these, a one-session CST intervention resulted in no difference in symptoms compared to controls.
  • Seven studies evaluated the effects of CBT/CST on fatigue and sleep disturbance. One study reported a decreased incidence of fatigue and sleep disturbance using an audio recording for coping skills training prior to chemotherapy. Two studies reported improvement in sleep with a four- to eight-week CBT intervention, but only one of these also reported improvement in fatigue. One study reported improvement in sleep and fatigue with a five-session CBT intervention, two other studies showed improvement in sleep but no change in fatigue, and one study reported no improvement in either of these two symptoms.
  • Four studies reported effects of CBT/CST on all three symptoms concurrently. One showed improvement in fatigue and sleep but no impact on pain. One study reported less sleep disturbance but no difference in pain or fatigue. One reported lower ratings of worst pain immediately after the CBT program and greater reduction in pain and fatigue six months after the intervention compared to controls. One study found no differences in any of the three symptoms with a CST intervention.

Meditation

Four studies were included.

  • Three of these studies used mindfulness-based interventions. One study reported significant improvements in both fatigue and sleep among outpatients who participated in an eight-week intervention.

Music

  • Four studies looked at the effect of music on pain. Two studies found significant improvements in a pre-/posttest design using 30 minutes of preferred music among hospitalized patients. Two other studies found no difference in pain with listening to music compared to control groups.
  • Two studies tested a music intervention on fatigue. One found a significant effect, and one found no difference in fatigue between intervention and control groups.

Conclusions:

Findings of this review were equivocal.

Limitations:

  • Although the authors stated a criterion for inclusion of examination of at least two of the three symptoms of interest, the review appeared to include studies in which only one of these symptoms was reported.
  • Few investigators used multisymptom interventions and evaluations.
  • Measures of symptom clusters were not been well identified.
  • Some instruments were stated to potentially be more sensitive; however, the scales and individual items that were most useful to measure this symptom cluster were not determined.
  • Timing, dosage, and frequency of interventions varied among studies, making it difficult to draw systematic conclusions. Most music interventions were very brief.
  • This review did not provide study details, such as clear sample descriptions, sample sizes, or actual statistical results, and no effect sizes were calculated, although some studies used the same outcome measures.

Nursing Implications:

Although the findings did not clearly demonstrate the effects of these interventions across studies, the authors concluded that these interventions hold promise. Although such interventions carry minimal risk to patients, some interventions would require substantial time and resource commitment to provide.

Lee, Y.J., Hyun, M.K., Jung, Y.J., Kang, M.J., Keam, B., & Go, S.J. (2014). Effectiveness of education interventions for the management of cancer pain: A systematic review. Asian Pacific Journal of Cancer Prevention, 15, 4787–4793.

doi: 10.7314/APJCP.2014.15.12.4787
Print

Purpose:

STUDY PURPOSE: To evaluate evidence of the effectiveness of education interventions in pain management

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy:

DATABASES USED: MEDLINE, EMBASE, Cochrane Library, KISS, KMBASE, and KoreaMed
 
KEYWORDS: MeSH headings and keywords for neoplasems, analgesics, various specific opioids, health education, and pain management
 
INCLUSION CRITERIA: English or Korean language; peer-reviewed publication; trials investigating educational interventions for pain; included both randomized, controlled trials and nonrandomized studies

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: 3,324
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: A Cochrane Risk of Bias Assessment Tool: for Non-Randomized Studies (ACROBAT-NRSI) and the Cochrane tool for randomized studies

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 27 with ten randomized, controlled trials included in the meta-analysis
  • TOTAL PATIENTS INCLUDED IN REVIEW = 2,380
  • SAMPLE RANGE ACROSS STUDIES: 30–1,256 patients
  • KEY SAMPLE CHARACTERISTICS: Not provided

Results:

The most frequent educational used tool was a booklet. A few studies involved the discussion of self-control and relaxation, but most of the content was description of pain management and misconceptions regarding the use of opioids. An analysis of seven randomized, controlled trials' (using the Brief Pain Inventory) effects on severe pain showed an SMD –0.34 (CI = 95%, –0.55, –0.13, p = 0.001). The SMD of average pain was –0.73 (CI = 95%, –0.64, –0.15, p = 0.002). The effects on pain in studies using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire showed no significant effect.

Conclusions:

This analysis suggests that educational interventions have a positive effect on pain control.

Limitations:

  • High heterogeneity in the analysis
  • Diverse educational interventions
  • The analysis included a few studies that also incorporated more psychoeducational types of interventions; however, these were included with simple educational booklet use in the meta-analysis.
  • Most of the studies had an undetermined risk of bias.

Nursing Implications:

The findings of this meta-analysis need to be viewed with some caution given the heterogeneity found in the analysis, the risk of bias determined. and the lack of differentiation between the education provided via booklets or other materials and the psychoeducational interventions that also included counseling, discussion, and relaxation techniques. However, it is clear that patients who need pain management also need education for self-management. Yet it is not clear if simple education alone is sufficient to facilitate effective patient self-management with analgesics.

Ling, C.C., Lui, L.Y., & So, W.K. (2012). Do educational interventions improve cancer patients' quality of life and reduce pain intensity? Quantitative systematic review. Journal of Advanced Nursing, 68(3), 511–520.

doi: 10.1111/j.1365-2648.2011.05841.x
Print

Purpose:

To complete a systematic review to evaluate the effect of patient education on the pain intensity, pain interference, and quality of life of patients with cancer 

Search Strategy:

  • Databases searched were MEDLINE, CINAHL, PubMed, EMBASE, PsycINFO, and Database of Abstracts of Reviews of Effects (DARE).
  • Search keywords were cancer, malignancy, neoplasm, tumor, nursing, pain, pain management, educational intervention, coaching, training, barriers, mood, well-being, wellness, anxiety, functional ability, patient teaching, patient education, quality of life, and systematic review.
  • Studies were included if they
    • Were randomized controlled trials of pain education for cancer patients
    • Were published in English
    • Involved adults with cancer-related pain and educational intervention in the form of information, instructions, or advice via written or auditory means by a healthcare provider to a patient with cancer
    • Included quality-of-life measures based on functional status, perceived pain control, well-being, anxiety, satisfaction with pain treatment, pain interference, physical functioning, and pain intensity and interference
  • Studies were excluded if they involved only caregivers or family members or if they used measures of quality of life or pain as the only outcome measures.
     

Literature Evaluated:

The search retrieved 68 references. Authors considered 23 references. Authors evaluated studies on the basis of methodological quality assessment; two independent reviewers assessed all studies by using the Jadad scoring system. In the event of a discrepancy, a third reviewer evaluated the study. Data were obtained by means of the PICO (participants, interventions, comparison, and outcomes) approach. The study employed six different instruments to measure quality of life across four studies; two instruments were used to evaluate pain (three studies used the Brief Pain Inventory).

 

Sample Characteristics:

  • The final number of studies analyzed was four.
  • The sample size, across studies, was 647 patients. The sample range was 97–189 patients.
  • Patients were American or Australian, 55–62 years old, and recruited from outpatient clinics. The sample included various types of pain and cancer diagnoses.

Phase of Care and Clinical Applications:

Clinical applications: late effects and survivorship, palliative care
 

Results:

Pain scores decreased as a result of the educational interventions in each study, but effects of education on quality of life were not statistically significant.

Conclusions:

A limited number of studies evaluating effects of education on cancer pain and quality of life are available. Based on available studies, education about pain has little effect on quality of life in the specified patient population.

Limitations:

  • The studies used different tools to evaluate quality of life
  • Whether authors assessed methodological quality is unclear.

Martinez, K.A., Aslakson, R.A., Wilson, R.F., Apostol, C.C., Fawole, O.A., Lau, B.D., . . . Dy, S.M. (2014). A systematic review of health care interventions for pain in patients with advanced cancer. American Journal of Hospice and Palliative Care, 31, 79–86.

doi: 10.1177/1049909113476129
Print

Purpose:

STUDY PURPOSE: To evaluate the effectiveness of healthcare interventions targeting pain in patients with cancer

TYPE OF STUDY: Systematic review

Search Strategy:

DATABASES USED: PubMed, CINAHL, PsycINFO, DARE, and Cochrane Collaboration; reference lists were used to identify additional studies.

KEYWORDS: Search terms and strategy specifics are in an online appendix to this article.

INCLUSION CRITERIA: Random or nonrandom trials with a control group. Patient-centered and institutional change interventions were included in the definition of healthcare interventions. Pain was included as an outcome.

EXCLUSION CRITERIA: Not specified

Literature Evaluated:

TOTAL REFERENCES RETRIEVED = 1,3014

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: GRADE system of quality evaluation; risk of bias was high in seven studies and moderate in another seven studies.

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 19 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 97
  • KEY SAMPLE CHARACTERISTICS: Mixed tumor types; median follow-up was 8 weeks (range was 2–24 weeks); all had advanced cancer.

Phase of Care and Clinical Applications:

  • APPLICATIONS: Palliative care

Results:

Of the studies, 89% examined patient educational activities. Two focused on provider-level interventions. Fifty-five percent of studies (11 studies) that measured knowledge and barriers found significant improvement in barriers to pain management. Five studies measured pain knowledge–two of these showed improvement. Forty-seven percent of the 19 studies showed significant improvement in pain outcomes compared to the control group. Findings varied by the type of intervention used, and results suggest that the use of multiple educational modalities may be more effective. The number of patient encounters in studies varied widely.

Conclusions:

Psychoeducational interventions significantly can reduce barriers to pain management, improve pain knowledge, and improve pain outcomes.

Limitations:

  • Many studies had small sample sizes and moderate to high risk of bias. 
  • The samples had little ethnic diversity. 
  • Although most used the Brief Pain Inventory, studies used different components of the tool and individual subscales only.

Nursing Implications:

Psychoeducational interventions can reduce patient barriers to pain management, improve relevant knowledge, and have a positive impact on pain. Multimodal interventions combining various educational media and follow-up appear to be more effective than alternatives. Data are limited to show effects of institutional, provider-focused interventions, but results in this area are promising. A combination of provider- and patient-focused interventions should be evaluated.

Phianmongkhol, Y., Thongubon, K., & Woottiluk, P. (2015). Effectiveness of cognitive behavioral therapy techniques for control of pain in lung cancer patients: An integrated review. Asian Pacific Journal of Cancer Prevention, 16, 6033–6038. 

doi: 10.7314/APJCP.2015.16.14.6033
Print

Purpose:

STUDY PURPOSE: To synthesize the evidence regarding effectiveness of cognitive behavioral techniques (CBT) for pain in patients with lung cancer

TYPE OF STUDY: Systematic review

Search Strategy:

DATABASES USED: PUBMED, EMBASE, CINAHL, DARE, ProQuest 5000, ScienceDirect, Centre for Reviews and Dissemination. In addition, specific journals and various sources for unpublished studies were searched.
 
INCLUSION CRITERIA: Patients spoke English or Thai, had lung cancer and a life expectancy of at least two months, were experiencing cancer-related pain requiring opioids, and had a positive response to opioid medications and an average pain between 4–7 on a 0–10 scale
 
EXCLUSION CRITERIA: Patients with major psychiatric illness who had major surgery or other intervention within 30 days of the study

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: 2,009
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Joanna Briggs methodology was used to assess study quality.

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 3
  • TOTAL PATIENTS INCLUDED IN REVIEW = 211
  • SAMPLE RANGE ACROSS STUDIES: 43–121 patients
  • KEY SAMPLE CHARACTERISTICS: Patients with lung cancer as well as other tumor types

Phase of Care and Clinical Applications:

PHASE OF CARE: Late effects and survivorship
 
APPLICATIONS: Palliative care 

Results:

The review included two studies that involved such interventions as distraction and relaxation and imagery rather than true CBT-approach interventions. No conclusions were drawn due to the lack of substantial evidence.

Conclusions:

Very limited evidence exists regarding effects of CBT-type interventions for pain among patients with lung cancer.

Limitations:

  • Limited number of studies included
  • Low sample sizes
  • Results of quality evaluation are not clearly provided.

Nursing Implications:

This review showed there is little evidence to determine effectiveness of CBT for pain in patients with lung cancer.

Santos Salas, A., Fuentes Contreras, J., Armijo-Olivo, S., Saltaji, H., Watanabe, S., Chambers, T., . . . Cummings, G.G. (2016). Non-pharmacological cancer pain interventions in populations with social disparities: A systematic review and meta-analysis. Supportive Care in Cancer, 24, 985–1000. 

doi: 10.1007/s00520-015-2998-9
Print

Purpose:

STUDY PURPOSE: To examine the evidence for nonpharmacological cancer pain interventions in populations with disparities of income, ethnicity, or gender
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy:

DATABASES USED: MEDLINE, CINAHL, Cochrane Collaboration, Health Technology Assessment, Database of Abstracts of Reviews of Effects, Proquest Dissertations and Theses
 
KEYWORDS: Search terms used for MEDLINE are provided in an appendix
 
INCLUSION CRITERIA: Patients 18 years and older, nonpharmacologic cancer pain interventions, randomized controlled trials, controlled trials and pre-/post designs
 
EXCLUSION CRITERIA: Not specified

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: 4,623
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane Collaboration risk of bias tool

Sample Characteristics:

FINAL NUMBER STUDIES INCLUDED = 3
 
TOTAL PATIENTS INCLUDED IN REVIEW = 232
 
SAMPLE RANGE ACROSS STUDIES: 67–97 patients
 
KEY SAMPLE CHARACTERISTICS: One study was of varied cancer types, looking at ethnicity and income; one examined Hispanic women with breast cancer; and one included several minority group patients with various tumor types.

Phase of Care and Clinical Applications:

APPLICATIONS: Palliative care

Results:

Interventions included pain education, culturally sensitive online support and education, and coaching versus controls. Meta-analysis of pooled results from these three studies did not show a significant overall effect on pain intensity. Interventions across studies varied in terms of frequency, duration, and intensity.

Conclusions:

This analysis did not demonstrate a significant impact of psychosocial/psychoeducational types of interventions on pain intensity among disadvantaged patient groups. There is insufficient evidence to draw any firm conclusions.

Limitations:

  • Few studies were included.
  • Generally high risk of bias in included studies

Nursing Implications:

No firm conclusions can be drawn regarding the effectiveness of psychosocial interventions for pain management among disadvantaged patient groups. There is a lack of research in this area. Findings here point to the need to develop and test these types of interventions for potentially vulnerable patient populations.

Sheinfeld Gorin, S., Krebs, P., Badr, H., Janke, E.A., Jim, H.S., Spring, B., . . . Jacobsen, P.B. (2012). Meta-analysis of psychosocial interventions to reduce pain in patients with cancer. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 30(5), 539–547.

doi: 10.1200/JCO.2011.37.0437
Print

Purpose:

  • To perform a meta-analysis to obtain a current, comprehensive, and robust estimate of the effect of psychosocial interventions on cancer-related pain
  • To determine  whether the effects of psychosocial interventions on pain in patients with cancer differ by intervention type (skills- versus education-based approach)
  • To explore, in the study context, the relationship between intervention design and patient sociodemographics

Search Strategy:

  • Databases searched were MEDLINE, PsycINFO, CINAHL, EMBASE, and the Cochrane Library.
  • Search terms indicating pain (e.g., pain, nociceptors) and presence of cancer (e.g., neoplasm, cancer, leukemia) were combined with terms relating to psychosocial interventions (e.g., psychotherapy, hypno$, desensitis$, meditate$) and publication types (e.g., randomized controlled trial, controlled clinical trial).
  • Studies were included if they
    • Were published in English on a date that fell in a period after the earliest date available in each database and before 2011.
    • Included adult subjects (those 18 years old or older) with a diagnosis of cancer or who were undergoing procedures for diagnosis of cancer.
    • Employed random assignment.
    • Assessed pain.
    • Included a usual-care or no-treatment control condition.
    • Employed a psychosocial intervention—that is, any approach involving cognitive behavioral techniques, stress management, relaxation training, education, hypnosis, or other experiential techniques. (Interventions could be provided in any of multiple formats, including individual, group, couples, telephone, or Internet-based modality.)
  • Studies were excluded if they used alternative therapies as the primary treatment, as is the case with massage and Reiki therapy.
     

Literature Evaluated:

The search retrieved 1,681 studies published 1996–2010. Three pairs of raters independently reviewed 1,681 abstracts, using an online coding program designed for this project. Studies meeting the inclusion criteria were evaluated for quality according to a modified seven-item coding scheme based on the Physiotherapy Evidence Database. The project leader reviewed findings from rater pairs, resolved discrepancies, and produced a final list of studies for full-text examination. The list of studies was divided among the three pairs of raters.
 

Sample Characteristics:

  • The number of studies that met inclusion criteria was 42; 37 provided sufficient data for meta-analysis.
  • The total sample was composed of 4,199 patients.
  • Authors did not report the sample range.
  • Of all patients, 66% were women. The sample was primarily white (72%). Most of the studies (65%) included cancer at various stages at baseline. At baseline, 54% of the sample was receiving chemotherapy. Of all patients, 71% were receiving outpatient care.

Results:

The weighted average effect size in 38 comparisons for pain severity (k = 38) was 0.34 (95% CI 0.23–0.46; p < 0.001). The weighted average effect size in four comparisons for pain interference was 0.40 (95% CI 0.21–0.60; p < 0.001). Among studies that measured pain severity, skills-based interventions yielded a higher but statistically nonsignificant effect size than did educational approaches (k = 18, g = 0.45 versus k = 19, g = –0.29, respectively; p = 0.22).

Conclusions:

Psychosocial interventions decrease cancer-related pain severity and the extent to which pain interferes with activities. Both skills instruction and education approaches can improve the management of cancer pain.

Tatrow, K., & Montgomery, G.H. (2006). Cognitive behavioral therapy techniques for distress and pain in breast cancer patients: A meta-analysis. Journal of Behavioral Medicine, 29(1), 17–27.

doi: 10.1007/s10865-005-9036-1
Print

Purpose:

To determine effectiveness of cognitive behavioral therapy (CBT) techniques in alleviating distress and pain in patients with breast cancer

Search Strategy:

  • Databases searched PsycINFO, MEDLINE, CancerLIT, and CINAHL 1974–June 2004. Investigators completed manual searches of reference lists and published meta-analyses.
  • Search keywords were anxiety, cognitive behavioral therapy, distress, depression, hypnosis, imagery, pain, relaxation, and treatment outcomes.
  • Studies were included in the review if they
    • Were randomized controlled trials (RCTs) with no-treatment or standard-care controls
    • Provided data sufficient to allow calculation of effect sizes
    • Measured pain and distress
  • Studies were excluded if they did not measure pain directly.

 

Literature Evaluated:

The search retrieved 61 studies. Investigators eliminated some on the basis of the exclusion criterion; meta-analysis involved 20 studies. Authors defined CBT very broadly: Interventions included relaxation; guided imagery; hypnosis; biofeedback; and approaches combining cognitive restructuring, skill trainingt, and other strategies to enhance problem solving and coping. Authors do not describe the specific procedure used to evaluate study quality.

Sample Characteristics:

  • Across the 20 studies, the sample was composed of 1,703 patients. Sample range was 16–215 patients.
  • Seven studies were included in the meta-analysis regarding interventions for pain. All patients in these seven studies, 474 patients over all, had breast cancer.

Results:

Authors noted that 69% of patients in treatment groups did better than controls with respect to pain. Regarding pain, effect size (d) was 0.49 (95% CI 0.09–0.90, p < 0.05). Subgroup analysis comparing individual versus group interventions showed that intervention format had no effect on pain.

Conclusions:

Findings suggest that CBT techniques produced a small to medium effect, as defined by the study, regarding the reduction of the pain of women with breast cancer.

Limitations:

  • Authors defined CBT very broadly, including such techniques as hypnosis and relaxation therapy, which would not usually be considered CBT approaches.
  • The number of studies and overall sample size for analysis regarding pain was relatively small. Authors did not report heterogeneity.
  • Though effect size was statistically significant, whether a reduction of 0.49 on a pain scale is clinically meaningful is unclear.

Nursing Implications:

Findings suggest that, for women with breast cancer, CBT may be a helpful adjunct to pain management. This finding is limited by the broad definition of CBT that this study employed. This study determined effect size on the basis of statistics. Future studies should define the type of change that is meaningful to patients—that is, change in symptoms.

Zhou, L., Liu, X.L., Tan, J.Y., Yu, H.P., Pratt, J., & Peng, Y.Q. (2015). Nurse‐led educational interventions on cancer pain outcomes for oncology outpatients: A systematic review. International Nursing Review, 62, 218–230.

Print

Purpose:

STUDY PURPOSE: To evaluate the effects of nurse-led education interventions on pain outcomes
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy:

DATABASES USED: CINAHL, MEDLINE, EMBASE, PsycINFO, Cochrane Library, China National Knowledge Infrastructure, and Proquest
 
KEYWORDS: Health education, education, psychoeducation, management, intervention, program, and cancer
 
INCLUSION CRITERIA: Randomized, controlled trials or quasi-experimental studies using any kind of educational intervention led by nurses for adult outpatients with cancer who were experiencing cancer-related pain with standard or usual care as comparator
 
EXCLUSION CRITERIA: Not specified

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: 1,093
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Johanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 6 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 78
  • SAMPLE RANGE ACROSS STUDIES: 74–227 patients
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Phase of Care and Clinical Applications:

APPLICATIONS: Palliative care 

Results:

Four studies included reported pain intensity, and the meta-analysis did not show a significant impact on pain intensity. Two of the four studies looking at patient attitudes showed decreased patient barriers to analgesic use. The studies reported improved patient knowledge.

Conclusions:

Nurse-led psychoeducational interventions improved patient knowledge for pain management, reduced barriers to analgesic use, and may have reduced pain intensity.

Limitations:

  • High heterogeneity
  • Very few studies included in the review

Nursing Implications:

This review did not add substantially to the current body of evidence regarding the effects of psychoeducational interventions on pain management. It did show that psychoeducational interventions can be beneficial in improving patient knowledge, reducing patient barriers to analgesic use, and possibly reducing pain intensity.

Research Evidence Summaries

Anderson, K.O., Cohen, M.Z., Mendoza, T.R., Guo, H., Harle, M.T., & Cleeland, C.S. (2006). Brief cognitive-behavioral audiotape interventions for cancer-related pain: Immediate but not long-term effectiveness. Cancer, 107(1), 207–214.

doi: 10.1002/cncr.21964
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Study Purpose:

To evaluate the effect of three brief cognitive behavioral interventions as adjunct treatment for chronic cancer-related pain

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to one of four groups: relaxation, distraction, positive mood, or wait-list control. Patients in the relaxation, distraction, and positive-mood groups received audiotapes and instructions to practice a specific psychoeducational technique at least five times weekly.The relaxation group received a 20-minute audiotape providing standard progressive muscle relaxation instructions. Patients in the distraction group selected an audiotape on a topic such as history, foreign language, or geography. Patients in the positive-mood group received audiotapes of positive-mood statements and positive-imagery suggestions. The research nurse telephoned all patients periodically to answer questions and encourage use of the assigned tapes. Patients completed assessments at baseline and in weeks 2–3, weeks 4–5, and weeks 8–9. For the first seven weeks, patients rated pain, according to a visual analog scale (VAS), before and after using the audiotapes. 

Sample Characteristics:

  • The sample was composed of 59 randomized patients, of whom 30 completed the study.
  • Mean patient age was 52 years. Age range was 30–80 years.
  • Of all patients, 79% were female and 21% were male.
  • Of all patients, 67% had breast cancer. Other diagnoses in the sample were prostate and lung cancer and multiple myeloma.
  • Of all patients, 72% were Caucasian; 23%, African American; and 5%, Hispanic. Of all patients, 54% were married, 21% were working, and 56% had an annual income greater than $40,000.

Setting:

  • Single site
  • Outpatient
  • MD Anderson Cancer Center, Houston, Texas

Study Design:

Randomized controlled trial

Measurement Instruments/Methods:

  • Brief Pain Inventory (BPI)
  • MD Anderson Symptoms Inventory
  • Numeric Rating Scale (0–10)
  • Functional Assessment of Cancer Therapy-General (FACT-G)
  • Profile of Mood States questionnaire
  • Outcome Expectancy and Self-Efficacy questionnaire

Results:

Subjects in the distraction and control groups reported a significant decrease (p < 0.05) in worst pain severity from baseline to follow-up at 2–3 weeks. Subjects in the positive-mood and control groups reported a significant decrease (p < 0.05) in BPI average pain score from baseline to the follow-up at 2–3 weeks. Analysis of mailed data showed that patients in the distraction group reported a mean reduction in pain severity of 1.16 (p = 0.004) and that, after listening to the tapes, patients in the relaxation group reported a mean reduction in pain severity of 0.9 (p = 0.023). Patients in the positive-mood group reported a nonsignificant increase in pain severity after audiotape use. Authors noted no differences between groups after 2–3 weeks. Authors noted no intervention effects on quality of life, mood, or perceived self-efficacy. There were no differences between groups in pain interference scores from the BPI. More than one-half the patients reported using the audiotapes at least five times per week. More than one-half the patients dropped out of the study or were lost to follow-up; 25% of these withdrew prior to the first follow-up assessment, at 2–3 weeks. The most common reasons for withdrawal were ineffectiveness of intervention and disease progression.

Conclusions:

Distraction and relaxation audiotapes appeared to produce immediate short-term decreases in pain intensity. However, authors observed no long-term effects and no overall differences between intervention groups and the control group.

Limitations:

  • The study had a small sample size, with fewer than 100 patients.
  • The study had risks of bias due to no attentional control and no blinding.
  • A large proportion of subjects dropped out of the study, resulting in an underpowered sample.
  • Authors did not state the frequency of follow-up telephone calls. Whether the timing or frequency of calls was different, group to group, is unknown. Such differences could have affected results.
  • Authors did not describe use of analgesics or changes in pain medications.
  • Whether the types of audiotapes selected for distraction were indeed distracting is unclear.
  • The intervention did not include education or cognitive restructuring, which are usually included in cognitive behavioral techniques.

Nursing Implications:

The findings of this study do not support the use of the specified techniques with audiotapes and minimal direct patient contact via telephone. This study does not add to knowledge regarding full cognitive behavioral techniques, because this study did not include many aspects typical of these techniques.

Given, B., Given, C.W., McCorkle, R., Kozachik, S., Cimprich, B., Rahbar, M.H., & Wojcik, C. (2002). Pain and fatigue management: Results of a nursing randomized clinical trial. Oncology Nursing Forum, 29, 949–956.

doi: 10.1188/02.ONF.949-956
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Study Purpose:

To compare, in a population of initial-chemotherapy patients reporting pain and fatigue, a supportive nursing intervention plus conventional care versus conventional care 

Intervention Characteristics/Basic Study Process:

The intervention consisted of an 18-week, 10-contact approach that included problem-solving strategies to manage symptoms and improve physical functioning and emotional health. Investigators conducted interviews at baseline and at 10 and 20 weeks. 

Sample Characteristics:

  • The sample was composed of 113 patients, of which 60 patients were controls and 53 patients (the experimental group) underwent the intervention.
  • Mean patient age was 58 years.
  • Of all patients, 28% were male and 72% were female.  
  • Breast and gynecologic cancers were most common cancer diagnoses in both groups, with lung and colon cancer representing the majority of the remainder of both groups.
  • Eligible patients were within 56 days of initiating their first cycle of chemotherapy following cancer diagnosis. In the experimental group, 72% of patients were in late-stage cancer (stage III or IV); in the control group, 66% of patients were in late-stage cancer.
  • At baseline, patients entered the study with an average of seven or more symptoms. Of all partients, 73% had at least some college education.

Setting:

  • Multisite
  • Outpatient
  • Four outpatient cancer treatment centers: two with comprehensive cancer centers, two community cancer treatment clinics

Phase of Care and Clinical Applications:

Phase of care: active treatment

Study Design:

Randomized clinical trial

Measurement Instruments/Methods:

  • A scale to measure these symptoms: nausea, vomiting, pain, fatigue, insomnia, difficulty breathing, coordination problems, fever, cough, dry mouth, constipation, anorexia, diarrhea, and mouth sores 
  • Two subscales of the Medical Outcomes Study 36 Short Form (SF-36), to measure the impact of the intervention on patients’ social and physical performance

Results:

At 22 weeks, patients in the experimental group reported 3.3 symptoms and patients in the control group reported 4.4 symptoms. Of those in both groups who reported neither pain nor fatigue at 20 weeks, the average number of other symptoms reported per patient was less than one symptom. At 20 weeks, authors noted no significant differences between groups in regard to pain or fatigue.

Conclusions:

Patients who received the intervention reported a significant reduction in the number of symptoms experienced and improved physical and social functioning. Fewer patients in the experimental arm reported both pain and fatigue at 20 weeks.

Limitations:

  • The disproportionately large number of patients with breast cancer in the sample may limit generalizability.
  • Authors did not enter into the analysis all the covariates that could affect outcomes.
  • Authors stated that the study was underpowered.

Nursing Implications:

Findings suggest that behavioral interventions targeted to patients with pain and fatigue can reduce the symptom burden, improve the quality of the daily lives of patients, and demonstrate the value-added role of nursing care for patients undergoing chemotherapy. This study supports the work of Thomas et al. (2012), which evaluated a nursing-led cognitive behavioral intervention focused on improving symptom management and overall quality of life.

Jahn, P., Kuss, O., Schmidt, H., Bauer, A., Kitzmantel, M., Jordan, K., . . . Landenberger, M. (2014). Improvement of pain-related self-management for cancer patients through a modular transitional nursing intervention: A cluster-randomized multicenter trial. Pain, 155, 746–754.

doi: 10.1016/j.pain.2014.01.006
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Study Purpose:

To evaluate Self Care Improvement through Oncology Nursing (SCION-PAIN), a nursing-administered program to reduce patients’ barriers and improve pain management and pain-related discharge management

Intervention Characteristics/Basic Study Process:

The intervention was a nurse-led counseling program to improve pain management and pain-related discharge management by reducing patient-related cognitive barriers. In the intervention group, the SCION-PAIN program was administered by specially trained ward nurses in cooperation with a study nurse. Initial education was standardized, and follow-up was tailored to individual needs. Three initial sessions were provided during hospital stay, and a follow-up telephone counseling session was done two to three days after discharge. Study measures were obtained at baseline, at discharge, and on days 7, 14, and 28 after discharge.

Sample Characteristics:

  • N = 202  
  • AVERAGE AGE = 55.9 years (control); 57.75 years (intervention)
  • MALES: 60 (57.1%) control; 59 (57.8%) intervention, FEMALES: 45 (42.9%) control; 43 (42.2%) intervention
  • KEY DISEASE CHARACTERISTICS: Gynecologic tumors 21/105 (20%) control and 20/101 (19.8%) intervention; urologic tumors 4/105 (3.8%) control and 12/101 (11.9%) intervention; hematologic malignancies 15/105 (14.3%) control and 1/101 (1%) intervention; gastrointestinal tumors 26/105 (24.8%) control and 40/101 (39.6%) intervention; other tumors 39/105 (37.1%) control and 28/101 (27.7%) intervention

Setting:

  • SITE: Multi-site  
  • SETTING TYPE: Multiple settings (inpatient and home setting)
  • LOCATION: Eighteen oncology wards from two German university hospitals

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Study Design:

Cluster-randomized trial

Measurement Instruments/Methods:

  • The effectiveness of the SCION-PAIN program was assessed by the difference in patient-related barriers to the management of cancer pain between the control and intervention groups using the Barriers Questionnaire II.
  • Secondary endpoints were measured with the Brief Pain Inventory (BPI), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ), the German Pain Coping Questionnaire (GPCQ), and the Medication Adherence Scale (MAS).
  • Health-related quality of life was measured by the EORTC-QLQ C30.

Results:

Compared to usual care, the SCION-PAIN program reduced cognitive barriers in cancer pain management more effectively (p < 0.02), and patients who participated in this program showed a significant increase in perceived knowledge of cancer pain. There was no difference between the groups in average or worst pain intensity. Patients in the intervention group adhered better to pain medications (p = 0.02).

Conclusions:

The results of this study demonstrated the effectiveness of the SCION-PAIN program as a brief, easily administered, nurse-led intervention to improve the self-management of pain in patients with cancer. Patient education could help to empower patients to actively participate in their pain treatment and develop self-management skills, improving adherence through care transitions. Participants in the program demonstrated a lower intensity of pain.

Limitations:

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Small number of randomized clusters; effects caused by differing personalities of the included participants; the responses to the information provision, different levels of social support, or of mental resilience were not assessed systematically

Nursing Implications:

The results of this study emphasized the integral role of nurses as part of the supportive or palliative care team. This study also confirmed that the inpatient period provides a very valuable and suitable timeframe to improve patients’ self-management and communication skills to prepare them for care transitions.

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.

doi: 10.1007/s00520-013-1722-x
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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.

Koller, A., Miaskowski, C., De Geest, S., Opitz, O., & Spichiger, E. (2013). Results of a randomized controlled pilot study of a self-management intervention for cancer pain. European Journal of Oncology Nursing, 17, 284–291.

doi: 10.1016/j.ejon.2012.08.002
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Study Purpose:

To evaluate the PRO-SELF© Plus Pain Control Program in a German population to determine effect sizes and feasibility

Intervention Characteristics/Basic Study Process:

Participants received six visits and four phone calls from an intervention nurse, who taught them effective ways to self-manage their pain, including how to set pain goals, how to titrate prescribed analgesics, how to communicate with their physician, and how to identify management strategies to achieve their pain goals. They also received nurse coaching on their recent successes and failures, as well as individualized information about their medications during each visit and phone call.

Sample Characteristics:

  • N = 39
  • AVERAGE AGE = 59.5 years
  • MALES: 51%, FEMALES: 49%
  • KEY DISEASE CHARACTERISTICS: Lung, breast, and other cancers; also evaluated fatigue, cognition, anxiety, and depression

Setting:

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

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Study Design:

  • Single-center, pilot, randomized, controlled trial

Measurement Instruments/Methods:

  • Numerical Pain Rating Scale for primary outcome measures
  • Patient pain questionnaire to evaluate patients’ knowledge of how to manage cancer pain
  • For additional symptoms (e.g., fatigue, cognition, anxiety):
    • Hospital Anxiety and Depression Scale
    • German Memorial Symptom Assessment Scale
    • Fatigue assessment questionnaire
    • DemTect
    • Eastern Cooperative Oncology Group performance status
    • Self-efficacy questionnaire

Results:

Neither average nor worst pain scores demonstrated statistically significant group-by-time interaction effects between the intervention and control group over the 10-week or 22-week period. The difference in the knowledge scores between the intervention and control groups was statistically significant. A large percentage of participants did not complete the study for various reasons.

Conclusions:

This study was the first to adapt a U.S.-developed pain intervention for a German audience. It did increase pain self-management knowledge and determine effect sizes for pain intensity scores.

Limitations:

  • Small sample (less than 100)
  • Subject withdrawals 10% or more

Nursing Implications:

The nursing intervention piece of this trial can have a great effect on the participants. In the U.S. and German trials, the nursing interventions were able to have an effect on fear of addiction, fear of tolerance, physical dependence, and the patients' understanding of taking their medications on a schedule.

Kravitz, R.L., Tancredi, D.J., Grennan, T., Kalauokalani, D., Street, R.L., Jr., Slee, C.K., . . . Franks, P. (2011). Cancer Health Empowerment for Living without Pain (Ca-HELP): Effects of a tailored education and coaching intervention on pain and impairment. Pain, 152, 1572–1582.

doi: 10.1016/j.pain.2011.02.047
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Study Purpose:

To determine the effectiveness of a lay-administered tailored education and coaching intervention on cancer pain severity, pain-related impairment, and quality of life  

Intervention Characteristics/Basic Study Process:

Patients with baseline “worst pain” of more than 4 on a 0–10 scale or at least moderate functional impairment were randomized to tailored education coaching (TEC) or enhanced usual care (EUC). TEC was delivered by a health educator in a private room one hour prior to the patients' visit with their healthcare provider. The intervention was a brief, patient-centered, tailored education and coaching intervention designed to enhance skills and self-efficacy for communicating with the oncologist while also correcting common misconceptions. The EUC intervention included review of selected aspects of a National Cancer Institute (NCI) booklet on pain control by a health educator. The TEC patients also received the NCI booklet. Patients completed questionnaires before and after the visit and were interviewed by telephone at 2, 5, and 12 weeks. Oncologists and follow-up assessors were blinded to patient group assignments.

Sample Characteristics:

  • The study reported on 258 patients (126 in the intervention group and 132 in the usual care group).
  • Mean patient age was 58 years.
  • The intervention group was 77.8% female and 22.2% male. The usual care group was 79.5% female and 20.5% male. 
  • Patients had breast and lung cancers and were predominantly white (71%).

Setting:

  • Mutlisite
  • Outpatient setting
  • Three healthcare systems and one private practice located in the metropolitan Sacramento, CA, area
  • Forty-five medical oncologists and three radiation oncologists participated in the study.

Phase of Care and Clinical Applications:

Patients were undergoing multiple phases of care.

Study Design:

The study was a randomized controlled trial.

Measurement Instruments/Methods:

  • Pain severity: two component numeric scales     
  • Pain impairment: five of thesix items from the Medical Outcomes Study
  • Functional status and well-being: physical and mental health components of the SF-12
  • Pain misconceptions: 11 five-point Likert scale items based on the Short Barriers Questionnaire
  • Self-efficacy for communicating about pain with the cancer doctor: five items in the Perceived Efficacy in Patient-Physician Interactions Scale
  • Pain-control self-efficacy: 2 items from the pain management subscale of the Chronic Pain Self-Efficacy Scale
     

Results:

The TEC patients had an improvement in pain-related impairment at two weeks (–0.025 points on a five-point scale, 95% confidence interval –0.43 to –0.06, p = 0.01), but it was not sustained at 6 and 12 weeks (p > 0.20). Pain severity was not improved at two weeks (–0.21 points on an 11-point scale, –0.60 to 0.17, p = 0.27). Pain misconceptions in both the intervention and control group decreased significantly between baseline and the two-week follow-up interview (p < 0.001), but there was no significant effect of the intervention on misconceptions at the two-week follow-up (p = 0.8). Communication self-efficacy increased more among the TEC patients than in the control group (p < 0.001).

Conclusions:

TEC provides a temporary improvement in pain impairment but not in pain severity.

Limitations:

The TEC intervention was designed to be brief and easy to deliver, but the health educator needed 30–40 hours of training and regular reinforcement (several hours every three to six months) in order to deliver the intervention appropriately. Physicians were not randomized to the study, so they may have learned from the TEC patients and applied it to the EUC patients. Generalizability of findings is limited due to the fact that the study was conducted in a metropolitan area in California, with no blinding.

Nursing Implications:

Because the TEC provided only temporary relief of pain impairment and no improvement of pain severity, it is not recommended for use in cancer-related pain management.

Kravitz, R.L., Tancredi, D.J., Jerant, A., Saito, N., Street, R.L., Grennan, T., & Franks, P. (2012). Influence of patient coaching on analgesic treatment adjustment: Secondary analysis of a randomized controlled trial. Journal of Pain and Symptom Management, 43, 874–884.

doi: 10.1016/j.jpainsymman.2011.05.020
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Study Purpose:

To estimate the effect of patient-centered tailored education and coaching (TEC) on the likelihood of analgesic treatment adjustment during oncology visits; to estimate the influence of treatment adjustment on subsequent cancer pain control

Intervention Characteristics/Basic Study Process:

Patients with at least a moderate baseline pain received TEC or control just prior to a scheduled oncology visit. Just after the visit, they reported on whether the physician recommended a new pain medication or a change in the dose of an existing medication. Pain severity and pain-related impairment were measured 2, 6, and 12 weeks later. TEC included assessing knowledge, attitude, and preferences; correcting misconceptions; teaching about pain control and communication with providers; planning communication; and rehearsing communication with physicians. Sessions occurred one hour before initial clinic visits and were conducted on an individual basis. Sessions were recorded on audiotape. Control patients received the Natiional Cancer Institute booklet on pain control. Patients completed questionnaires immediately after a clinic visit.

Sample Characteristics:

  • The sample was composed of 258 patients.
  • Patients' age range was 18–80 years.
  • Of all participants, 21.4% were male and 78.6% were female.
  • Diagnoses in the sample included lung, breast, prostate, head and neck, esophageal, colorectal, bladder, and gynecologic cancer.
  • Patients reported a score of 4 or higher, on a 0–10 scale, when asked to cite worst pain during the past two weeks or pain during the same period that interfered at least moderately with functioning.
  • Potentially eligible patients were identified using computer-generated lists. Consenting patients received an enrollment packet by mail and were promised $80 compensation for completing the trial.

Setting:

Settings included three health systems—academic medical center, health maintenance organization, and Veterans Affairs hospital—and one private practice, all in Sacramento, California.

 

Phase of Care and Clinical Applications:

  • Phase of care: active treatment
  • Clinical applications: elder care, palliative care

Study Design:

Randomized controlled trial

Measurement Instruments/Methods:

  • Medical Outcomes Study Pain Impairment Scale
  • Postvisit questionnaire regarding pain medication changes

Results:

  • Patients assigned to TEC were more likely than controls to report a change in the analgesic treatment regimen (60% vs. 36%, p < 0.01).
  • Significant effects persisted after adjustment for baseline pain, study site, and physician (adjusted odds ratio 2.61, 95% CI 1.55, 4.40, p < 0.01).
  • In a mixed-effects repeated-measures regression, analgesic change was associated with a sustained decrease in pain severity (p < 0.05).

Conclusions:

TEC increases the likelihood of self-reported, physician-directed adjustments in analgesic prescribing. Treatment intensification is associated with improved cancer pain outcomes.

Limitations:

  • The study had low accrual rates.
  • Invesigators obtained data about independent and dependent variables by means of patients' self-reports. The study shows poor concordance between patients' reports and medical record review.
  • Authors did not assess appropriateness of physicians' decisions.
  • Regression effects that may cause between-group comparisons may appear to be larger than they would be if analgesic change were randomly assigned.
  • Time points at which pain severity were measured are unclear.

Nursing Implications:

A routine oncology visit is an opportunity to adjust a patient’s analgesic regimen. Available evidence suggests that clinicians often miss opportunities to intensify analgesic regimens appropriately. Oncologists are often unaware of patients’ pain. Patients may be reluctant to discuss pain because of misconceptions about pain management or fear of distracting the physician. The findings of this study suggest that interventions to counter this reluctance, and to improve pain management, include education, including role-playing, that helps patients plan communication with physicians.

Kroenke, K., Theobald, D., Wu, J., Norton, K., Morrison, G., Carpenter, J., & Tu, W. (2010). Effect of telecare management on pain and depression in patients with cancer: A randomized trial. JAMA: The Journal of the American Medical Association, 304(2), 163–171. 

doi: 10.1001/jama.2010.944
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Study Purpose:

To determine whether centralized telephone-based care management cued by automated symptom monitoring can improve depression and pain in patients with cancer

Intervention Characteristics/Basic Study Process:

In this study, called the Indiana Cancer Pain and Depression Trial, centralized telecare management was conducted by a nurse-physician specialist team that worked in concert with automated home-based symptom monitoring. The means of monitoring was interactive voice recording or Internet. A nurse care manager assessed symptom response and medication adherence, provided pain- and depression-specific education, and made treatment adjustments according to evidence-based guidelines. Intervention patients received scheduled calls (at baseline, at 1 week, and at 4 and 12 weeks) and received calls when automated monitoring indicated problems in symptom management. Control group received usual care. Data were collected at baseline and at months 1, 3, 6, and 12.

Sample Characteristics:

  • The sample was composed of 405 patients, 202 in the intervention group and 203 in the control group.
  • Mean patient age in the intervention group was 58.7 years (SD = 11 years); in the control group, 59 years (SD = 10.6 years).
  • In the intervention group, 63% of patients were female and 37% were male. In the control group, 72% were female and 28% were male.
  • The sample included diverse cancer types (more than 20% of patients had breast cancer) and various disease stages. Patients had to have depression, pain, or both to be eligible. Depression was defined by a score equal or greater than 10 on the Patient Health Questionnaire-9; cancer pain, by a worst-pain score equal or greater than 6 on the Brief Pain Inventory (BPI). Baseline demographic and clinical characteristics between groups were balanced.

Setting:

  • Multisite
  • Outpatient
  • Sixteen community-based urban and rural oncology practices in Indiana

Study Design:

Randomized controlled trial

Measurement Instruments/Methods:

  • Twenty-item Hopkins Symptom Checklist (HSCL-20), to measure depression severity
  • BPI, to measure pain severity 
  • Single-item scale, 0–10, to measure overall quality of life
  • SF-12 Health Survey, to measure physical and mental components
  • Generalized Anxiety Disorder questionnaire, to measure anxiety
  • Somatic Symptom Scale, to measure physical-symptom burden

Results:

  • Over the 12 months of the trial, of the 274 patients with pain, the 137 patients in the intervention group had greater decreases in pain severity (≥ 30% decrease), as measured by the BPI (as a continuous severity score or as a categorical pain responder), than did the 137 patients in the usual care group (p < 0.001 for both groups).
  • Over the 12 months of the trial, of the 309 patients with depression, the 154 patients in the intervention group had greater decreases in depression (≥ 50% decrease), as measured by the HSCL-20 (as a continuous severity score or as a categorical depression responder), than did the 155 patients in the usual care group (p < 0.001).
  • The standardized effect size for between-group differences at 3 and 12 months was 0.67 (95% CI 0.33–1.02) and 0.39 (95% CI 0.01–0.77) for pain and 0.42 (95% CI 0.16–0.69) and 0.41 (95% CI 0.08–0.72) for depression.
  • The intervention group had better outcomes in several health-related quality-of-life domains: mental health, vitality, anxiety, and physical-symptom burden.

Conclusions:

This study showed that centralized telecare management with automated symptom monitoring may be a feasible approach for geographically dispersed urban and rural oncology practices. This approach may be effective in improving the pain and depression of cancer patients.

Limitations:

Lack of control of the type of cancer treatment and of the time lapse since treatment might have affected study findings.

Nursing Implications:

Cost will be involved in training the care manager and in the hiring of trained personnel. The cost-effectiveness of the collaborative care model needs to be further examined. Findings suggest that telecare management used with automatic systems cued by patient problems can be an effective approach.

Kwekkeboom, K. L., Abbott-Anderson, K., Cherwin, C., Roiland, R., Serlin, R. C., & Ward, S. E. (2012). Pilot randomized controlled trial of a patient-controlled cognitive-behavioral intervention for the pain, fatigue, and sleep disturbance symptom cluster in cancer. Journal of Pain and Symptom Management, 44, 810–822.

doi: 10.1016/j.jpainsymman.2011.12.281
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Study Purpose:

To test the effects of a psychoeducational intervention on pain, fatigue, and sleep disturbance.

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to the intervention group or the wait-list control group. The intervention consisted of a single one-on-one training session with a research nurse, which was followed by recorded guidance that provided imagery, relaxation exercises, and nature sounds. Most exercises lasted 20 minutes and were delivered via an mp3 player. The study lasted two weeks.

Sample Characteristics:

  • The sample was comprised of 78 patients (41% male, 59% female).
  • Mean age was 60.29 years (standard deviation = 11.09 years).
  • Patients had lung, prostate, colorectal, or gynecologic cancer.
  • Patients were receiving chemotherapy or radiation therapy and had multiple concurrent symptoms at baseline.
  • At study entry, all patients had to have fatigue, sleep disturbance, and pain scores of at least 3 on an 11-point numeric scale.
  • Of the patients, 71% were taking steroids, 59% were taking opioids, and 86% were taking antiemetics.
     

Setting:

  • Multisite
  • Outpatient
  • Midwestern United States

Phase of Care and Clinical Applications:

Patients were undergoing the active antitumor treatment phase of care.

Study Design:

The study used a randomized, controlled trial, pre- and postintervention design.

Measurement Instruments/Methods:

  • Selected items from various instruments, including the Brief Fatigue Inventory (BFI), Brief Pain Inventory (BPI), and Pittsburgh Sleep Quality Index (PSQI)
  • Eleven-point numeric scales, to measure symptoms
  • Patient diaries, which recorded use of cognitive-behavioral therapy (CBT) exercises
  • Symptom cluster score, calculated by averaging the pain, fatigue, and sleep disturbance scores
  • Symptom interference subscale of the MD Anderson Symptom Inventory (MDASI)

Results:

  • Comparison of pre- and postintervention symptom severity scores showed a significant reduction in the severity of pain, fatigue, and sleep disturbance and symptom interference (p = 0.000).
  • Symptom cluster scores and individual symptom scores declined in both the intervention and control groups.
  • The reductions in symptom cluster severity (p < 0.05), pain (p < 0.01), and fatigue (p < 0.05) were significantly greater in the intervention group than in the control group; however, the effect sizes (calculated as partial eta) were extremely small (range 0.041–0.093).

Conclusions:

The intervention demonstrated a small statistically significant effect on the symptoms of pain and fatigue and the overall symptom cluster of pain, fatigue, and sleep disturbance.

Limitations:

  • The study had a small sample size, with less than 100 patients.   
  • The study had risks of bias due to no blinding and no appropriate attentional control condition.
  • The sample included baseline and group differences of import.
    • The control group had higher depression scores at baseline than did the intervention group.
    • A greater number of those in the intervention group dropped out of the study, suggesting that the intervention was not well accepted. Intention-to-treat analysis used the last value carried forward. If symptoms worsened, this would produce biased results.
  • Although the intervention was called a CBT intervention, whether cognitive reframing or problem solving was a part of the intervention was unclear. The intervention appeared to have been a relaxation or imagery therapy.
  • Measurement validity and reliability were questionable.
    • Authors used Z-scores to compare sleep disturbance severity, rather than actual scores; the reason for this was unclear. The actual change in Z-scores for this symptom was larger than the score changes associated with other symptoms, but the Z-score change was not statistically significant.
    • Whether average individual symptom scores were more meaningful than the total score for the cluster was unclear.  
  • The intervention may be too expensive or impractical, in terms of training needs, to be feasible.

Nursing Implications:

The intervention was a relaxation or imagery therapy rather than a true CBT. The intervention was associated with short-term statistically significant benefits, but the actual size of the effect was small. Findings suggested that approaches using relaxation and imagery may result in some small benefit for patients, but the effect was weak.

Kwekkeboom, K. L., Abbott-Anderson, K., & Wanta, B. (2010). Feasibility of a patient-controlled cognitive-behavioral intervention for pain, fatigue, and sleep disturbance in cancer. Oncology Nursing Forum, 37, E151–E159.

doi: 10.1188/10.ONF.E151-E159
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Study Purpose:

To evaluate the feasibility of a patient-controlled, cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during treatment for advanced cancer and to assess the initial efficacy of the intervention.

Intervention Characteristics/Basic Study Process:

Patients provided baseline measures, such as measures relating to demographics and a symptom inventory, received education, and underwent training to use an mp3 player loaded with 12 cognitive-behavioral strategies (relaxation exercises, guided imagery, nature sounds). Patients used the strategies as needed for symptom management for two weeks and kept a log of symptom ratings with each use. Following the two-week intervention, patients completed a second symptom inventory and an evaluation of the intervention. Clinic staff identified patients who met the eligibility criteria based on diagnosis and treatment and then were briefly introduced to the study and asked if a research nurse could visit to provide additional information. The research nurse met with interested patients, assessed symptoms, and completed eligibility screening. Study purpose and procedures were explained, and written informed consent was obtained.

Sample Characteristics:

  • The sample was comprised of 30 patients (20% male, 80% female).
  • Mean age was 56.27 years (range 36–79).
  • All patients had advanced (recurrent or metastatic) cancer and were receiving chemotherapy or radiotherapy. Half of the patients had a diagnosis of gynecologic cancer. Patients had been diagnosed with lung cancer (n = 8), colorectal cancer (n = 6), and prostate cancer (n = 1).
  • Most patients were Caucasian, women, and had earned a bachelor’s degree or higher.
  • Almost all patients (n = 27) were taking two or more prescribed supportive medications to treat symptoms.
  • Studies were included if they included at least two of the following three symptoms:  pain rated 3 or higher on a 0-to-10 scale in the previous 48 hours, fatigue in the previous week, and sleep disturbance in the previous week. 
  • Studies were excluded if they involved postoperative or neuropathic pain.

Setting:

  • Multisite
  • Outpatient
  • Midwestern United States
     

Phase of Care and Clinical Applications:

  • Patients were undergoing multiple phases of care.
  • The study has clinical applicability for late effects and survivorship, end of life care, and palliative care.

Study Design:

The study used a one-group, pre- and postintervention design.

Measurement Instruments/Methods:

  • Demographic questionnaire and chart review form to record age, gender, education, race, ethnicity, cancer diagnosis, current treatments, and supportive medications prescribed, such as analgesics, steroids, psychostimulants, hypnotics, or sedatives
  • Symptom inventory, to measure
    • Pain severity, by means of four, 0-to-10 numeric rating scales for pain now, worst pain, least pain, and average pain in the last 24 hours
    • Fatigue severity, by means of four, 0-to-10 scales for fatigue now, worst fatigue, least fatigue, and average fatigue in the last 24 hours
    • Sleep disturbance, by means of a 0-to-10 scale rating sleep disturbance in the last 24 hours and, from the Pittsburgh Sleep Quality Index (PSQI), a verbal rating of sleep quality
  • Additional symptoms and their effects on daily functioning, as assessed by the MD Anderson Symptom Inventory (MDASI), which includes items measuring 13 common cancer-related symptoms and their effect on general activity, mood, work, relations with others, walking, and enjoyment of life
  • Treatment log book, in which patients tracked each time they used a cognitive-behavioral strategy. Data tracked were time of day; strategy used; and immediate pre- and posttreatment scores, on a 0-to-10 scale, regarding severity of pain, fatigue, and sleep disturbance
  • Poststudy evaluation, a 12-item survey created, for the current study, to assess patients’ perceptions of the acceptability of the study procedures. Among the items evaluated were time commitment; equipment; and questionnaires and factors relating to the patient-controlled, cognitive-behavioral intervention, such as length, variety, and usefulness.
     

Results:

  • Symptom scores at two weeks did not differ significantly from baseline scores; however, significant reductions in pain, fatigue, and sleep disturbance severity were found in ratings made immediately before and after the use of a cognitive-behavioral strategy.
  • Mean pain scores decreased from 4.54 pretreatment to 2.77 posttreatment.
  • Mean fatigue scores decreased from 4.9 pretreatment to 3.44 posttreatment.
  • Average sleep disturbance scores decreased from 5.05 pretreatment to 2.81 posttreatment.

Conclusions:

The patient-controlled, cognitive-behavioral intervention is feasible and may reduce the day-to-day severity of co-occurring pain, fatigue, and sleep disturbance.

Limitations:

  • The study had a small sample size, with less than 100 patients.
  • The study had a risk of bias due to no control group.
  • The study used a convenience sample comprised of well-educated, primarily female patients—a sample that may not be representative of all populations.
  • Uncontrolled extraneous variables, such as supportive medication use, could have influenced symptom outcomes.

Nursing Implications:

The findings support nurse education and the recommendation of the specified patient-controlled, cognitive-behavioral interventions for the management of pain, fatigue, and sleep disturbance. In regard to patient care and symptom management at all stages of cancer, nurses are the front-line educators of patients. This intervention supports the principle of autonomy for patients able to participate actively in care. Further study—a randomized, controlled trial to test the efficacy of the intervention for co-occurring pain, fatigue, and sleep disturbance—was under way at the time this study was published.

Lovell, M.R., Forder, P.M., Stockler, M.R., Butow, P., Briganti, E.M., Chye, R., . . . Boyle, F.M. (2010). A randomized controlled trial of a standardized educational intervention for patients with cancer pain. Journal of Pain and Symptom Management, 40(1), 49–59.

doi: 10.1016/j.jpainsymman.2009.12.013
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Study Purpose:

To determine if an educational video and/or booklet for people with advanced cancer and pain can improve pain management and quality of life and decrease anxiety, pain, and pain interference

Intervention Characteristics/Basic Study Process:

Patients were recruited from multiple oncology and palliative care clinics and were randomly allocated to one of four treatment groups. Patients in group 1 received standard care only. Those in group 2 received standard care plus a booklet. In group 3, patients received standard care plus a video. Group 4 patients received standard care plus a booklet and video. The video depicted patients, a caregiver, and health professionals talking about cancer pain and management. The booklet, published by the New South Wales Cancer Council, contained text and cartoons about pain and its management. Text was written for a reading age of 12 years. Patient assessment was done at baseline and at weeks 2 and 4 after study entry.

Sample Characteristics:

  • The sample was composed of 140 patients.
  • Mean patient age was 69 years.
  • Of all patients, 57% were female and 43% were male.
  • The sample included a variety of cancer types, with the most frequent being breast and lung cancers. In regard to other patient characteristics, 10% of patients had university-level education, 73% were married, and 77% were in an urban setting. All patients had a pain rating greater than or equal to 2. At baseline, 77% patients were on opioids and 22% were receiving inadequate pain control.

Setting:

  • Multisite
  • Outpatient
  • Australia

Study Design:

Randomized controlled trial

Measurement Instruments/Methods:

  • Barriers Questionnaire
  • Wisconsin Brief Pain Questionnaire
  • Pain management index, a composite of the analgesic strength rating and worst-pain rating
  • Uniscale for the assessment of global quality of life
  • Hospital Anxiety and Depression Scale
  • Patients' daily diaries of pain

Results:

Barriers were low in all groups at baseline. The barriers scores dropped more in the intervention groups than in the control group, but differences from control or between the other three groups were not significant. There was a significant difference (p < 0.05) in the addiction subscale change in the booklet-only and video-only groups. Authors reported a significantly higher change in average pain (p = 0.0214) between the control and video-and-booklet groups. Authors noted marginal differences in average pain between groups in all other combinations. Reduction in worst pain was significantly greater (p = 0.05) in the video-and-booklet group than in the control group. The size of the differences was small (–1.12). Authors noted no other between-group differences. The presence of a partner increased the effect of any intervention on outcomes (p = 0.004, p < 0.01). According to the pain management index, there was no difference between groups in regard to pain management. Authors observed no difference between groups in regard to anxiety or depression, and they observed no significant change in anxiety or depression. All groups reduced overall consumption of opioids.

Conclusions:

In this study a self-administered educational intervention consisting of a booklet and video was associated with a reduction in average pain, worst pain, and fear of addiction.

Limitations:

  • The study had a risk of bias due to no blinding.
  • The duration of the study was relatively short, four weeks.
  • Baseline pain scores of 2 or higher would result in inclusion of patients with only mild pain. Baseline pain intensity data are not provided.
  • Authors do not state how much relevant education was included in standard care. Variability among providers could have resulted in substantial differences among subjects.

Nursing Implications:

Findings suggest that standardized education that includes a video and booklet can be helpful in pain management. The effectiveness of the intervention is due, presumably, to greater patient and caregiver involvement in pain management. This study showed that the combination of a booklet and video, along with standard care, was the most effective intervention. The content of each may have reinforced the other. Use of a standardized set of educational materials, such as those used in this study, can be a practical, efficient way to supplement other interventions to manage pain, may be effective in involving patients more directly in pain management, and may help to remove barriers to and misconceptions about pain management.

Mahigir, F., Khanehkeshi, A., & Karimi, A. (2012). Psychological treatment for pain among cancer patients by rational-emotive behavior therapy—efficacy in both India and Iran. Asian Pacific Journal of Cancer Prevention, 13, 4561–4565.

doi: 10.7314/APJCP.2012.13.9.4561
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Study Purpose:

To find out the influence of rational emotive behavior therapy (REBT) on pain intensity among patients with cancer in India and Iran

Intervention Characteristics/Basic Study Process:

The intervention included eight two-hour sessions of REBT characterized as cognitive techniques, imagery techniques, and behavioral techniques. The intervention was given to the experimental group for 45 days (10 sessions), and at the end of the intervention, pain of patients was evaluated again. Empathy, warmth, respect, relationship building, and family dynamics were covered in the first session; personal experience assessment was covered in the second session; counseling and REBT approach were covered in the third session; REBT was covered in the fourth through seventh sessions; and coping with stress was covered in the final session. Workbooks, worksheets, and practice exercises were included in the program. What the intervention actually entailed is not clear.

Sample Characteristics:

  • N = 88
  • AGE = 21–52 years
  • MALES, FEMALES: Not described
  • KEY DISEASE CHARACTERISTICS: Patients with cancer (no information about disease site or stage)
  • OTHER KEY SAMPLE CHARACTERISTICS: None described

Setting:

  • SITE: Multi-site
  • SETTING TYPE: Hospital
  • LOCATION: India and Iran

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Multiple phases of care

Study Design:

  • RCT

Measurement Instruments/Methods:

  • McGill Pain Questionnaire

Results:

Because of errors in the tables, interpreting the findings is difficult. Data in the table are transposed from the information included in the narrative text; this makes interpretation of the information uncertain. The overall reliability of the data is in question.

Conclusions:

The authors have asserted that an intervention resulted in reduction in pain perception, as measured by the McGill Pain Questionnaire, in an experimental group receiving REBT when compared with a control group. However, discrepancies in the article make interpretation difficult.

Limitations:

  • Small sample (less than 100)
  • Measurement validity/reliability questionable
  • Other limitations/explanation: Rigor of scientific reporting is questionable.

Nursing Implications:

Nurses are well aware that psychoeducational interventions can affect pain control. This study aims to support that contention. This study does not provide additional strong support in this area because of multiple study limitations.

Ohlsson-Nevo, E., Karlsson, J., & Nilsson, U. (2016). Effects of a psycho-educational programme on health-related quality of life in patients treated for colorectal and anal cancer: A feasibility trial. European Journal of Oncology Nursing, 21, 181–188. 

doi: 10.1016/j.ejon.2015.10.002
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Study Purpose:

To evaluate the effects of a psychoeducational program on quality of life (QOL) among patients treated for colorectal and anal cancer

Intervention Characteristics/Basic Study Process:

After patients were discharged post-initial surgery, they were invited to participate in the program. Patients completed a baseline assessment and then were randomized to the study program or usual care. Patients in the control group received standard care, including a phone call on postoperative day 3, a follow-up surgical visit after one month, and an appointment with the social worker/counselor if desired. Control group participants were offered the educational program after the end of the study. The intervention included seven meetings with informational lectures delivered once weekly in groups of about 10 patients. Caregivers could attend educational sessions. Lectures were followed by group discussion among patients only to reflect on the topic among peers and speak about worries and experiences. Study assessments were done at 1, 6, and 12 months after study entry.

Sample Characteristics:

  • N = 86   
  • MEAN AGE = 66 years
  • MALES: 62.8%, FEMALES: 37.2%
  • CURRENT TREATMENT: Chemotherapy, radiation, combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Colorectal or anal cancer, most were stage I or II 
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority were retired and currently married.

Setting:

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

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Multiple phases of care

Study Design:

  • Randomized, controlled trial with wait-list control–longitudinal repeated measures

Measurement Instruments/Methods:

  • Short Form 36 Health Survey (SF-36)

Results:

At one month, the intervention group reported better overall mental health status (effect size = 0.51, p = 0.01). Bodily pain score were more positive in the intervention group at six months (p = 0.01), but not significantly different from that of control patients at any other time point, although among the intervention group, average pain scores improved over time, while among controls remained essentially stable.

Conclusions:

The psychoeducational program evaluated here was associated with better mental health status and bodily pain subscale scores over time.

Limitations:

  • Small sample (< 100)
  • 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
  • Measurement validity/reliability questionable
  • At baseline, those in the intervention group had significantly higher reported general health and social functioning and better pain scores.
  • Repeated measures design with possible testing effects

Nursing Implications:

The psychoeducational program tested here appeared to have positive health-related QOL benefits for participants. Ongoing research is needed to identify the most beneficial timing, amount, content, and format of educational and counseling for short- and long-term benefit to patient with various cancer types and treatment regimens.

Oldenmenger, W.H., Sillevis Smitt, P.A., van Montfort, C.A., de Raaf, P.J., & van der Rijt, C.C. (2011). A combined pain consultation and pain education program decreases average and current pain and decreases interference in daily life by pain in oncology outpatients: A  randomized controlled trial. Pain, 152(11), 2632–2639.

doi: 10.1016/j.pain.2011.08.009
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Study Purpose:

To test the effect, on pain severity and interference with daily life, of standard care versus care supplemented with pain education

Intervention Characteristics/Basic Study Process:

Patients were referred by primary care providers and randomly assigned to the pain education program or standard care. The education intervention was provided in clinics and by telephone. Intervention included enhancing knowledge about pain and pain treatment.  Patients were contacted weekly by telephone. During each call they reviewed pain outcomes and side effects and received reinforcement education as necessary. In the report of the study, authors did not described standard care. The study was conducted over eight weeks. The study was originally designed to evaluate three groups; however, because of low recruitment the study compared only two interventions.

Sample Characteristics:

  • The sample was composed of 59 patients. 
  • Mean patient age was 59 years (SD = 11 years).
  • Of all patients, 35% were male and 65% were female.
  • The sample included patients with various tumor types; 82% of patients had metastatic disease.
  • Average duration of pain was five months. All patients had nociceptive pain.
     

Setting:

  • Single site
  • Outpatient
  • Rotterdam, the Netherlands

Phase of Care and Clinical Applications:

Phases of care: multiple phases of care

Study Design:

Randomized controlled trial

Measurement Instruments/Methods:

  • Brief Pain Inventory
  • World Health Organization analgesic ladder (step scale)
  • Pain management index
  • Medication Event Monitoring Systems (MEMSs)
     

Results:

Average reduction in pain intensity declined in both groups. The decline was 0.8 (20%) greater in those receiving the intervention program (p = 0.03) than in those receiving standard care. Pain-related interference declined more in the intervention group (p < 0.01).  In the group that received the intervention, the percentage of patients who received both round-the-clock and as-needed medication increased: Of those receiving the intervention, 88% changed to this approach. In the group receiving standard care, 50% changed to the approach (p = 0.003). Adherence was initially the same across both groups. In the last two weeks, however, adherence was 74% in the standard-care group and 85% in the intervention group (p = 0.028).

Conclusions:

The educational and support intervention was associated with greater decline in pain severity and pain-related interference, more aggressive pharmacologic management, and slightly better patient adherence over an eight-week period.

Limitations:

  • The study had a small sample, with fewer than 100 participants.
  • The study had a risk of bias due to no blinding.
  • Authors noted that the study was underpowered.

Nursing Implications:

Findings from this study support evidence that psychoeducational interventions can improve pain management and pain outcomes in patients with cancer-related pain. Incorporating such interventions and related follow-up programs into nursing practice can greatly benefit patients with chronic pain.

Rustøen, T., Valeberg, B.T., Kolstad, E., Wist, E., Paul, S., & Miaskowski, C. (2012). The Pro-Self© Pain Control Program improves patients' knowledge of cancer pain management. Journal of Pain and Symptom Management, 44, 321–330.

doi: 10.1016/j.jpainsymman.2011.09.015
Print

Study Purpose:

To evaluate the effects of a psychoeducational intervention on increasing patients’ knowledge and attitudes of cancer pain management

Intervention Characteristics/Basic Study Process:

Prior to the intervention, nurses were trained by the PI and study oncologist. The PI listened to audio recordings of the sessions with nurses and patients in the intervention and control groups to ensure fidelity. The Norwegian version of the Pro-Self Pain Control Program intervention was used. A trained oncology nurse made home visits at 1, 3, and 6 weeks and telephone interviews at 2, 4, and 5 weeks. At the week 1 visit, the nurse delivered educational information tailored to each patient’s needs and patients received written instructions about pain and side effect management and were taught how to use a pillbox and how to use a script to help discuss pain management with their physician. At weeks 2, 4, and 5, the intervention group was contacted via phone to review pain score and medication use. The consent of the Pro-Self Pain Control Program was reinforced, and patients received coaching on how to address pain management needs. The same was done for home visits on weeks 3 and 6. The control group was given a booklet about cancer pain management and received home visits and telephone calls on the same schedule as intervention patients. The focus of interaction in the control group was adherence with completing the study diary. Both groups recorded measurements in a pain diary every night.

Sample Characteristics:

  • N = 179
  • MEAN AGE = Pro-Self group: 64.32 years (SD = 11.4 years), control group: 67.38 years (SD = 11.4 years)
  • MALES: 47.1% in the Pro-Self group, 55.4% in the control group; FEMALES: 52.9% in the Pro-Self group, 44.6% in the control group
  • KEY DISEASE CHARACTERISTICS: Patients with cancer who had bone metastasis, confirmed radiographically
  • OTHER KEY SAMPLE CHARACTERISTICS: Primary diagnoses include breast, prostate, and colon cancer; 19.5% with other diagnosis; outpatients; able to read, write, and understand; Karnofsky Performance Status (KPS) of 50 or greater; pain intensity score of 2.5 or greater on a 0–10 scale

Setting:

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

Phase of Care and Clinical Applications:

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

Study Design:

  • Randomized, controlled trial

Measurement Instruments/Methods:

  • KPS
  • 0–10 pain intensity scale
  • Pain experience scale (PES)
  • Demographic questionnaire
  • Independent student t-tests or chi-squared analysis, mixed-model analysis

Results:

At baseline, control patients reported a higher KPS score than those in the intervention group (p = 0.0003). Improvement in all individual and overall (p < 0.001) scores on the PES was noted for patients in the Pro-Self group. A statistically significant improvement was seen in nine items on the PES scale for patients in the intervention group.

Conclusions:

The study resulted in an increase in knowledge of cancer pain management in the Pro-Self group.

Limitations:

  • Baseline sample/group differences of import: Difference in KPS scores
  • Risk of bias (no blinding)
  • Risk of bias(sample characteristics): Control group had higher KPS score than the Pro-Self group at enrollment, and patients in the Pro-Self group had a lower PES score on one item than the control group
  • Other limitations/explanation: The PES was modified when it was translated into Norwegian, some items on the PES were reverse coded, a drug dependence item on the PES was deleted (because of translational issues), and an item was added because it was included on another pain questionnaire by the American Pain Society’s Quality of Care Committee.

Nursing Implications:

Additional research is recommended to examine the influence of the level of education of participants on interventions to improve cancer pain management.  A similar study was completed in the United States using a similar intervention, but the results were not as dramatic (the U.S. study yielded significant improvements in only five of the nine items on the PES, versus significant improvements in all 9 areas in the Norwegian study), which suggests cultural, educational, and demographic influences. Although individualized patient education tends to be more effective, this requires additional time and resources for planning and intervention.

Rustøen, T., Valeberg, B.T., Kolstad, E., Wist, E., Paul, S., & Miaskowski, C. (2014). A randomized clinical trial of the efficacy of a self-care intervention to improve cancer pain management. Cancer Nursing, 37, 34–43. 

doi: 10.1097/NCC.0b013e3182948418
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Study Purpose:

To evaluate the efficacy of a psychoeducational nursing intervention for pain management on pain outcomes

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to control or intervention groups. The intervention was a version of the PRO-SELF pain control program adapted from the work of Miaskowski et al. A specially trained oncology nurse visited patients in their homes on weeks 1, 3, and 6, and did telephone interviews on weeks 2, 4, and 5. Individual patient knowledge deficits were identified based on responses on the pain experience scale, and educational information was tailored to meet individual needs. Patients were given written instructions about pain and the management of adverse effects, and they were taught how to use a weekly pill box and how to use a script to communicate with their physicians about unrelieved pain. During telephone contact, education was reinforced and patients were coached about how to modify pain management or contact the physician to improve pain outcomes. Home visits also involved additional coaching and ongoing education. Patients in the control group were given a booklet about cancer-related pain management and received home visits and telephone interviews with the same timing, focusing on encouraging patients to maintain a pain diary. Pain assessments were done during telephone interviews. The principal investigator listened to tapes of the intervention and control group nurses to ensure the fidelity of the intervention and control conditions.

Sample Characteristics:

  • N = 147
  • MEAN AGE = 65.5 years
  • MALES: 52%, FEMALES: 48%
  • KEY DISEASE CHARACTERISTICS: Various tumor types; breast and prostate cancer were most frequent. 
  • OTHER KEY SAMPLE CHARACTERISTICS: Baseline average pain score was 3.6 and worst pain scores were 5; greater than 50% reported breakthrough pain, and about 50% had been in pain for seven months or more; average daily intake of oral morphine equivalents was 190 mg 

Setting:

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

Phase of Care and Clinical Applications:

  • APPLICATIONS: Palliative care 

Study Design:

Randomized, controlled trial with attention control

Measurement Instruments/Methods:

  • Patients kept daily diary of numeric ratings of pain for least, average, and worst pain and whether they had breakthrough pain episodes.  
  • Daily opioid doses were also recorded in the diaries.

Results:

There was a significant reduction in least, worst, and average pain in both groups. There were no differences based on group or the combinations of group and time. For both groups, there were significant decreases over time in total doses of opioids taken and no differences between groups in dosage changes. There were no differences between the groups in adjuvant pain medication use or other relevant interventions such as bone-modifying agents.

Conclusions:

As used here, the psychoeducational nursing intervention to increase self-care in pain management did not have an impact on pain outcomes. It is not clear if the intervention changed patient behavior in pain management, though both groups in the study had some reduction in pain intensity.

Limitations:

  • Risk of bias (no blinding)
  • Subject withdrawals ≥ 10%

Nursing Implications:

The psychoeducational intervention used here improved patients’ knowledge about pain management, but it was not clear if it resulted in any behavior change, and there were no differences in pain outcomes between those who received the full intervention and those who were given attention and written instructions for pain control. More evidence is needed to determine the most effective components of this type of intervention. These findings also suggest that the provision of written directions for pain control, daily patient attention via diary use, and simple nursing attention may be as effective as more structured interventions.

Syrjala, K.L., Abrams, J.R., Polissar, N.L., Hansberry, J., Robison, J., DuPen, S., . . . DuPen, A. (2008). Patient training in cancer pain management using integrated print and video materials: A multisite randomized controlled trial. Pain, 135(1–2), 175–186.

doi: 10.1016/j.pain.2007.10.026
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Study Purpose:

To test the hypothesis that patients who received standardized training about pain would have fewer barriers to treatment, report lower pain, and be more likely to take prescribed opioids than patients who received a control training unrelated to pain

Intervention Characteristics/Basic Study Process:

Patients were stratified by institution and ethnicity and then randomly assigned to control and treatment groups. Pain training included a videotape and review, with a nurse, of a handbook. The nurse focused on the concerns of the individual patient. Patients completed a checklist of eight common barriers to pain control, indicating those that he or she had wondered about. The nurse helped the patient  apply information to the patient's own situation. To assist in communication about pain, the patient then completed a checklist of things to tell the doctor. Patients were encouraged to use the checklist in communicating with the doctor and to complete a checklist any time pain was not well controlled or when other symptoms occurred. Control group patients received interventions similar in format, but these focused on nutrition. After 72 hours patients in both groups received telephone contact that reinforced training. By telephone investigators gathered patients' ratings of pain, nausea, and eating symptoms. Patients' initial training took 30–45 minutes. Follow-up calls lasted about 10 minutes. Patients completed outcome assessments at baseline and at one, three, and six months. At each time point, physicians and nurses rated patients' usual and worst pain, using the same 0–10 scale that patients used.

Sample Characteristics:

  • Eighty-eight patients completed the study.
  • Mean patient age was 55.5 years. Age range was 27–80 years.
  • In the intevention group, 58% of patients were female and 42% were male. In the control group, 71% were female and 29% were male.
  • The sample included multiple cancer diagnoses. Breast cancer was the most frequent diagnosis: Of all patients, 23%–31% had breast cancer. In the sample 77% had metastatic or systemic disease, and most had advanced-stage disease with a life expectancy of at least six months at the time of study entry. Of all patients, 90.5% were Caucasian. More than 50% of patients had attended some college or had earned a college degree. Baseline Eastern Cooperative Oncology Group performance status was similar in both groups, at a mean of 1.03–1.30.

Setting:

  • Multisite
  • Outpatient
  • Six urban and rural oncology clinics in the United States

Study Design:

Randomized blind controlled trial

Measurement Instruments/Methods:

  • Barriers Questionnaire (BQ)
  • Brief Pain Inventory (BPI)
  • Memorial Symptom Assessment Scale (MSAS)
  • Functional Assessment of Cancer Therapy-General (FACT-G)
  • ECOG Performance Status (total daily morphine equivalent doses for pain control calculated from tables in Cancer Pain Guidelines)

Results:

From baseline the group that received training about pain had a greater decrease in barrier beliefs about cancer pain (p < 0.001), with a 0.3 point decrease, and a greater average decrease in usual pain (0.8 decrease, p = 0.03). At one month, the pain-training group reported 25% lower mean pain ratings. The pain-training group used higher doses of opioids than did the control group (p = 0.001). There were no significant differences between groups regarding worst pain, pain interference with function, or overall symptom severity. Authors noted differences between groups at one month, but there were no differences at three and six months. The pain-training group had greater narrowing of the gap between the patient’s self-assessment of pain and the nurse’s pain ratings (p = 0.001). The institution providing care was significantly associated with change in barriers to pain treatment (p < 0.001) and change in worst pain (p < 0.001). From baseline, pain interference with function (p = 0.02) was higher for nonwhites. Researchers found that, frequently, doses of medications were not re-evaluated and that patients had not told physicians about side effects or that they had stopped taking analgesics. Chart reviews presented no evidence of patients using the checklists in clinic visits or in communication with nurses and physicians.

Conclusions:

The training intervention appeared to have only a short-term positive effect on patients' management of pain. Observations regarding related communications between patients and their professional care teams, along with significant differences in outcome by institution, point to the impact of providers in effective pain management.

Limitations:

  • The study had a small sample size, with fewer than 100 patients.
  • The sample included few nonwhite participants, and findings showed significant differences regarding ethnic covariates. These facts suggest that findings cannot be generalized to various ethnic groups.
  • Although the study design included blinding of providers and those who obtained study data, authors suggest that contamination across the two groups was likely.
  • Authors did not discuss patient supports or caregiver involvement in pain management.
  • Authors did not describe the characteristics associated with the significant institution-related differences in outcomes.

Nursing Implications:

Findings suggest that a training component may help patients self-manage pain and communicate with care providers. However, the single intervention in this study had only short-term effects that varied by institution. This points to the importance of the engagement of care providers in ongoing pain management and the need for future research to study combined patient-provider efforts. Consistent reinforcement of patient education and use of communication aids may improve long-term outcomes.

Thomas, M.L., Elliott, J.E., Rao, S.M., Fahey, K.F., Paul, S.M., & Miaskowski, C. (2012). A randomized, clinical trial of education or motivational-interviewing–based coaching compared to usual care to improve cancer pain management. Oncology Nursing Forum, 39(1), 39–49.

doi: 10.1188/12.ONF.39-49
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Study Purpose:

To test the effectiveness of two interventions, compared to usual care, in decreasing attitudinal barriers to cancer pain management, decreasing pain intensity, and improving functional status and quality of life (QoL)

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to one of three groups: control, standardized education, or coaching. Patients in the education and coaching groups viewed a video and received a pamphlet about managing cancer pain. In addition, patients in the coaching group participated in four telephone sessions facilitated by an advanced practice nurse–interventionist who used motivational interviewing techniques to decrease attitudinal barriers to cancer pain management. Questionnaires were completed at baseline and at six weeks after the final telephone call. Authors used analysis of covariance to evaluate differences in study outcomes among the three groups.

Sample Characteristics:

  • The sample was composed of 227 patients—that is, patients who completed the end-of-study evaluation.
  • In the control group, average age was 58.7 years; in the education group, 62.5 years; in the coaching group, 61.8 years.
  • Of all patients, 90.1% were male and 9.9% were female.
  • In the sample the most common cancer types were lung, prostate, and head and neck cancers. Breast and colon cancers, myeloma, and mixed types made up the remainder of diagnoses.

Setting:

  • Multisite
  • Six outpatient oncology clinics (four Veterans Affairs facilities, one county hospital, and one community-based practice)
     

Phase of Care and Clinical Applications:

  • Phases of care: multiple phases of care
  • Clnical applications: late effects and survivorship

Study Design:

Randomized clinical trial

Measurement Instruments/Methods:

  • Attitudinal-barriers assessment: Authors chose the Barriers Questionnaire (BQ), a 27-item instrument, 0–5 scale, to measure barriers to cancer pain management. Barriers include concern about side effects, concern about tolerance, fear of addiction, fatalism, fear of disease progression, desire to be a good patient, fear of injections, and concern about distracting the physician from curing disease.
  • Pain assessment: The study used the Brief Pain Inventory, a  0–10 scale self-report, to assess intensity and quality of pain, the extent to which pain relief was obtained, and the extent to which pain interferes with function.
  • Functional status: The SF-36, a 0–100 scale, assessed eight health concepts (physical functioning, role limitations because of physical health problems, bodily pain, social functioning, role limitations because of emotional health problems, general mental health, vitality, and perception of general health). Higher scores reflect higher functioning.  
  • QoL: The study measured four QoL domains (physical, social, emotional, and functional well-being) by means of the FACT-G, a five-point Likert-type scale, with each subscale summed to obtain a subscale score and all individual items summed to obtain a total score. Total score can range 0–112.
     

Results:

  • Authors found no differences among the three groups in any of the subscale or total BQ scores.
  • Assessment of measures at the second time point found no differences among the three groups in regard to pain intensity or pain relief. However, at the end of the study, authors noted significant differences in mean pain interference scores (p < 0.01).
  • The SF-36 showed significant differences among the groups in general health, vitality, mental health, and the mental component (as measured by summary score). The coaching group had higher mental health component scores than did the control group.
  • Authors noted no significant differences among groups in regard to any of the FACT-G subscales or total scores.
  • Patients in the coaching group reported a statistically significant decrease in pain-related interference with function and improved ratings of vitality, mental health, and general health. Compared to standardized education, coaching was associated with clinical improvements in cancer pain management (decreased cancer pain intensity and improvement or stability in functional status and QoL).

Conclusions:

Findings suggest that coaching may be beneficial to cancer pain management, especially as management relates to collaborative development of individualized care plans that decrease symptoms.

Limitations:

  • The fact that more than 90% of the sample was male may be a limitation. 
  • The study employed a convenience sample, a fact that may limit applicability to other oncology populations. 
  • The study did not alter the amounts or types of analgesics prescribed. This fact may limit results.   
     

Nursing Implications:

Focused sessions consisting of 30 minutes of motivational-interviewing coaching by an advanced practice nurse may improve the management of cancer pain and overall health outcomes.

Tse, M.M., Wong, A.C., Ng, H.N., Lee, H.Y., Chong, M.H., & Leung, W.Y. (2012). The effect of a pain management program on patients with cancer pain. Cancer Nursing, 35(6), 438–446.

doi:10.1097/NCC.0b013e3182360730
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Study Purpose:

To determine if a specified pain management program for cancer patients is associated with pain reduction, an increase in pain medication, and a reduction in barriers to pain management

Intervention Characteristics/Basic Study Process:

Participants were assigned to an experimental group or a control group. Each group received routine pain management education, including a one-page pamphlet about pain and the use of pharmacotherapeutics and nonpharmacotherapeutic pain relief methods.  Follow-up sessions of approximately 15 minutes each occurred on days 3 and 5. Follow-up sessions included pain assessment and reinforcement of information from the booklet. The experimental pain management program included a 30-minute individual education session and follow-up sessions on days 3 and 5. On follow-up days pain was assessed and education and management methods reinforced.

Sample Characteristics:

  • The sample was composed of 38 patients.
  • In the experimental group, mean patient age was 61.96 years. In the control group, mean patient age was 63.94 years.
  • Of all patients, 60% (24 patients) were male; 13 men were in the experimental group and 11 men were in the control group. Of all patients, 40% (14 patients) were female; 7 women were in each group.
  • The sample included various cancers, including breast, bone, lung, gastrointestinal, genitourinary, and skin cancers, with and without metastases.
  • At baseline, pain intensity in the experimental group was 4.7; in the control, 4.2. All participants took analgesics regularly to relieve pain, and 60% used nonpharmacologic methods to control pain. Length of stay was seven days.

Setting:

  • Single site
  • Inpatient
  • Palliative care and hospice ward, Hong Kong
     

Phase of Care and Clinical Applications:

  • Phase of care: end-of-life care
  • Clinical applications: end-of-life care and palliative care

Study Design:

Prospective randomized controlled trial with pre/post-test

Measurement Instruments/Methods:

  • Numeric Rating Scale, a Likert-type self-report
  • Barriers Questionnaire-Taiwan (BQT), which offered an internal consistency of 0.89 and a test-retest reliability of 0.90
  • Record Sheet for PRN Analgesic (a component of the medical record)
  • Spreadsheetlike record of nonanalgesic methods (spreadsheet maintained by researcher)
  • Paired t-test for within group and independent t-test for comparison between experimental and control groups

Results:

  • At baseline and after day 7, authors observed no significant difference between control group and experimental group in regard to pain (P > 0.05). However, in terms of frequency, the experimental group used significantly more analgesics and more nonpharmacologic strategies (P > 0.05). The group that received the pain management program (PMP) increased use of nonpharmacologic strategies (p < 0.05, mean = 0.75 [SD = 0.72]). Authors noted significant post-PMP differences in analgesic use (p < 0.05), with more analgesics used in the PMP group (analgesics mean = 1.15 [SD = 0.81]).  
  • BQT results reflected a significant change (P < 0.05) in the experimental group in six of eight measures. The change could mean that participants felt more empowered in their handling of pain and use of pharmacologic and nonpharmacologic pain strategies.
  • The pain scores of both groups decreased, although authors noted no significant difference between the decrease in each group (P > 0.05). However, the experimental group significantly increased its use of analgesics and nonpharmacologic strategies and reduced barriers to pain management.

Conclusions:

Development and implementation of a pain management education program directed at reducing patient barriers and misconceptions about pharmacologic and nonpharmacologic strategies may help increase a patient's sense of empowerment regarding pain management.

Limitations:

  • The study had a small sample, with fewer than 100 patients. Authors did not cite a power analysis of sample size.
  • Analgesic dosing was not consistently tracked and recorded.
     

Nursing Implications:

Pain education for patients is recommended.

Tulipani, C., Morelli, F., Spedicato, M.R., Maiello, E., Todarello, O., & Porcelli, P. (2010). Alexithymia and cancer pain: The effect of psychological intervention. Psychotherapy and Psychosomatics, 79(3), 156–163.

doi: 10.1159/000286960
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Study Purpose:

To evaluate the impact of psychological intervention on pain perception and levels of alexithymia in patients with cancer

Intervention Characteristics/Basic Study Process:

For six months, patients were randomly included in a psychological intervention or control group. The intervention consisted of biweekly 90-minute sessions provided by a clinical psychologist trained in psychotherapy and psycho-oncology. Main aspects included psychoeducation regarding mechanisms of pain, daily management of cancer-related issues, emotional reaction to illness, problem solving, cognitive restructuring of dysfunctional illness-related concerns and beliefs, stress management, and progressive relaxation. Investigators assessed outcomes at baseline and at the end of the study. Authors did not describe the control condition.

Sample Characteristics:

  • The sample was composed of 104 patients.
  • Mean patient age was 47.4 years.
  • Of all patients, 55.8% were female and 44.2% were male.
  • Subjects had a variety of cancer types. Gastrointestinal was the most frequent. Of all patients, 37.5% had metastatic disease. The average length of education was fewer than 10 years. Of all patients, 79.8% were married and 90% were receiving chemotherapy with or without radiation therapy.

Setting:

  • Single site
  • Outpatient
  • Italy

Study Design:

Randomized controlled trial

Measurement Instruments/Methods:

  • Brief Pain Inventory
  • Toronto Alexithymia Scale (TAS-20)
  • Mental Adjustment to Cancer Scale
  • Illness Behavior Questionnaire
  • Hospital Anxiety and Depression Scale subscales for anxiety and depression
  • SF-12

Results:

Control patients were significantly younger and had more progressive cancer than those in the intervention group (p = 0.01). In multiple regression analysis, only alexithymia and scores from the physical component of the SF-12 were predictive of pain intensity (p < 0.001). Patients with progressive disease had higher pain intensity, more interference with daily living, and worse pain (p < 0.001). At the end of six months, compared to controls, patients who received the intervention had significantly lower scores relating to pain intensity (p = 0.03), alexithymia (p < 0.001), hypochondriasis (p = 0.016), and disease perception (p = .013) and showed improvement in these problems from baseline (p < 0.007).

Conclusions:

Findings of this study showed that the psychological intervention tested seemed to have a positive effect on pain and alexithymia in patients with cancer. Alexithymia was predictive of pain intensity.

Limitations:

  • The study had risks of bias due to no appropriate control group, no attentional control, and no blinding. Authors did not describe the control condition.
  • Authors did not discuss other interventions provided to manage pain, so whether differences and changes in medical management of pain influenced results is unknown.
  • The control group had more progressive cancer and was younger. Both factors could have influenced pain and other outcomes.
  • Authors did not state whether patients in the intervention group attended all sessions.
     

Nursing Implications:

Findings suggest that psychological intervention, including cognitive behavioral techniques and progressive relaxation, can be helpful to patients in regard to management of pain; however, limitations of the study design must be considered when interpreting results. The intervention provided was time-consuming and would be associated with cost, which was not discussed. Future researchers should construct well-designed studies to determine the most helpful type and dosage of interventions of this type.

van der Peet, E.H., van den Beuken-van Everdingen, M.H., Patijn, J., Schouten, H.C., van Kleef, M., & Courtens, A.M. (2009). Randomized clinical trial of an intensive nursing-based pain education program for cancer outpatients suffering from pain. Supportive Care in Cancer, 17, 1089–1099.

doi: 10.1007/s00520-008-0564-4
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Study Purpose:

To investigate the effect of intensive home-based nurse-provided education on pain levels, pain knowledge, quality of life, anxiety, and depression in patients with cancer

Intervention Characteristics/Basic Study Process:

Patients with cancer were randomized to receive either a pain education intervention or usual care. Pain, knowledge, quality of life, anxiety, and depression were measured at baseline and after four and eight weeks. In the intervention group, effects on symptom levels were communicated to the treating physician. The program included a brochure about pain management, instructions about how to record pain intensity in a diary, and simulation of help-seeking behavior. In the intervention group, palliative care nurses made three home visits. After these visits, nurses communicated with the physician, by means of a written report of pain control and recommendations regarding dose or medication changes. Home visits were at weeks 1, 3, and 6. Follow-up telephone calls to members of the intervention group occurred at weeks 4 and 8.

Sample Characteristics:

  • The sample was composed of 20 patients age 18 or older.
  • In the intervention group, 52.1% of patients were male and 47.9% were female. In the control group, 38.3% of patients were male and 61.7% were female.
  • All patients
    • Had been diagnosed with cancer and informed of their diagnosis.
    • Were able to understand and complete the questionnaire.
    • Had a present pain score of 4 or higher on a 0–10 scale.
    • Agreed to participate in the study.
  • Patients were excluded from the study if they had completed their curative anticancer treatment before the year 2000.

Setting:

  • Multisite
  • Home
  • Limburg, the Netherlands

Phase of Care and Clinical Applications:

  • Phase of care: not stated
  • Clinical applications: elder care, palliative care

Study Design:

Randomized controlled trial

Measurement Instruments/Methods:

  • Brief Pain Inventory (selected questions)
  • Translated version of the Family Pain Questionnaire (Ferrell, Rhiner, & Rivera, 1999), to measure patients’ knowledge about pain
  • European Organization for Research and Treatment quality of life questionnaire (EORTC QLQ-C30 version 3.0), to measure quality of life and nonpain symptoms
  • Dutch version of the Hospital Anxiety and Depression Scale (HADS)

Results:

At four weeks, the level of pain had decreased in the intervention group (p = 0.02) but not at eight weeks. Significant decreases in pain only persisted in those patients with a high pain score (7–10) at baseline (p = 0.00). Knowledge of pain was significantly increased in the intervention group at week 8 (p < 0.00). Authors found no correlation between increased pain knowledge and decreased pain levels. In 60% of cases, recommendations in nurses' reports were ignored.

Conclusions:

In the short term, the nurse-administered pain-related education program lowered pain intensity in patients with cancer and increased patients' knowledge about pain.

Limitations:

  • The study had a risk of bias due to no appropriate attentional control condition.
  • The patients in the study knew that they were enrolled in pain research.
  • Study design did not account for differing severities of illness and disease progression.
  • Written communication with the treating physicians proved inadequate.
  • Authors provided no information about any changes made in pain management regimens during the course of the study.

Nursing Implications:

In regard to pain and pain management, additional attention must be paid to patient education and to communication between patients and healthcare professionals. The following components should be characteristic of patient education programs: involvement of the patient and family or caregivers, communication with the patient to reinforce information and monitor the plan, integration of medical care into the nursing education program, clear instructions regarding provider notification, and use of a pain diary. The components have the potential to reduce pain. Study findings showed that communications to physicians, written by palliative care nurses, were ignored 60% of the time, suggesting that this form of communication is ineffective. Educating the patient and helping patients to self-advocate in interactions with physicians are important goals.

Wang, Y., Huang, H., Zeng, Y., Wu, J., Wang, R., Ren, B., & Xu, F. (2013). Pharmacist-led medication education in cancer pain control: A multicentre randomized controlled study in Guangzhou, China. Journal of International Medical Research, 41, 1462–1472.

doi: 10.1177/0300060513491170
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Study Purpose:

To assess the impact of education on analgesic medication for patients with cancer-related pain

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to control or education groups. The education group received three information booklets and eight face-to-face education and counseling sessions over four weeks. Clinical pharmacists contacted patients daily to review outcomes and made recommendations to physicians based on patient response.   Pharmacists received standardized training. Pharmacists assisted patients to complete study questionnaires.

Sample Characteristics:

  • N = 237  
  • MEAN AGE = 51.3 years
  • AGE RANGE = 23–70 years
  • MALES: 79%, FEMALES: 21%
  • KEY DISEASE CHARACTERISTICS: More than 80% had metastatic disease; tumor types not reported

Setting:

  • SITE: Multi-site   
  • SETTING TYPE: Inpatient   
  • LOCATION: China

Study Design:

  • RCT

Measurement Instruments/Methods:

  • Brief Pain Inventory

Results:

Pain and analgesic knowledge increased significantly from baseline in both groups, and pain intensity and interference decreased significantly in both groups from baseline (p < .05). Knowledge improved the most in patients who had not previously used analgesics. Pain intensity declined more in the intervention group.

Conclusions:

Education and counseling were associated with improvement in pain scores.

Limitations:

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Selective outcomes reporting
  • Other limitations/explanation: Possibility of testing bias with repeated measure of the same tool. It is not clear if there was potential for contamination if the study was done in the same inpatient settings. It is stated that pharmacists made recommendations based on patient responses, but it is not stated if pain control regimens were changed during the study or what analgesics patients were receiving, so it is impossible to know if the education intervention was responsible for differences found.

Nursing Implications:

The likely effectiveness of psychoeducation for improving pain control is known; this study supports that evidence in an inpatient setting.

Ward, S., Donovan, H., Gunnarsdottir, S., Serlin, R.C., Shapiro, G.R., & Hughes, S. (2008). A randomized trial of a representational intervention to decrease cancer pain (RIDcancerPain). Health Psychology: Official Journal of the Division of Health Psychology, American Psychological Association, 27(1), 59–67.

doi: 10.1037/0278-6133.27.1.59
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Study Purpose:

To determine if the changes associated with the RIDcancerPain program—in regard to beliefs, coping, pain severity, and pain-related interference—are greater than the changes associated with standard education

Intervention Characteristics/Basic Study Process:

Subjects were randomized to the control group or the intervention group. The control group received attention and standardized information about pain. Information was basic. The control group received a booklet, in question-answer format, that provided a review of common misconceptions about pain and information about managing the side effects of opioids. The intervention consisted of one session. Coverage of each subject during the session lasted 20–60 minutes. Patients were asked to describe beliefs about cancer pain (cause, timeline, consequences, cure, and control). The intervener identified and discussed misconceptions, provided accurate information, and cited the benefits of implementing changes based on the information provided. Patients discussed misconception-related limitations and losses. After the intervention (2–3 days later), patients in the intervention group had the opportunity to ask questions and provide comments via telephone, in a conversation with the research nurse. Patient-related baseline measures were gathered by means of self-report questionnaires that had been mailed to the patient prior to the intervention. Measures were also gathered at 1 and 2 months.

Sample Characteristics:

  • The sample was composed of 176 patients.
  • Mean patient age was 55.11 years (SD = 11.52 years).
  • Of all patients, 57.4% were female and 42.6% were male.
  • The most frequent diagnoses were breast, gastrointestinal, genitourinary, and gynecologic cancers. Of all patients, 64.8% did not have health problems other than cancer; 40.9% were receiving concomitant chemotherapy. Of all patients, 71% were married and 86.9% were Caucasian. Mean severity of pain at baseline was 4.17 on a 10-point scale.

Setting:

  • Multisite
  • Outpatient clinic in Wisconsin

 

Study Design:

Randomized controlled trial

Measurement Instruments/Methods:

  • Brief Pain Inventory (selected items relating to pain severity, pain-related interference with life, and beliefs about analgesic use)
  • Pain management index in regard to adequacy of analgesic use (a Likert-type scale, 0–3, for rating usual pain during the past week)
  • Quality of Life Index-Cancer Version

Results:

  • Compared to patients in the control group, patients in the intervention group showed greater decreases in barriers across time (p = 0.0025), with an effect size (d) of 0.765. In the intervention group, barriers decreased from baseline to the first follow-up month but then increased between the first- and second-month follow-ups.
  • There was a greater decrease in usual pain severity for patients in the intervention group (p = 0.0085). No other main effects in analysis of variance were shown in regard to the intervention.
  • Both groups of subjects showed decreased barriers over time.
  • Changes in pain severity and quality of life varied over time.
  • Of all patients, 21% dropped out of the study after completion of baseline measures. Dropouts had higher pain severity than did others.
  • Approximately 50% of subjects had adequate pain control according to severity measures at the time of study entry. Analysis of mediators of pain variables was inconclusive, demonstrating different apparent correlations at different points in time.

Conclusions:

The RIDcancerPain intervention reduced measured patient barriers to pain management and usual pain severity but demonstrated no effect on other measures of pain severity, coping, pain-related interference with life, or overall well-being.

Limitations:

  • The study had a risk of bias due to no appropriate control group. The attentional control group did not receive the follow-up telephone  calls that the intervention group received.
  • Authors provided no information about changes in analgesic regimen or other pain management approaches.
  • One-tailed tests of significance were used. This is a procedure consistent with the directional hypothesis posed, but it makes achievement of statistical significance more likely.
  • Authors provided no analysis of difference in subgroups of patients, based on adequacy of background pain control.

Nursing Implications:

Findings suggest that providing the information specified in the RIDcancerPain program can be beneficial in terms of overcoming known barriers to effective pain management. However, the effect of the program on overall pain control remains unclear: Findings suggest that time and attention may be the most important factors in dealing with barriers to pain management. (In the intervention group, the period in which effects were greatest was shortly after individualized sessions and follow-up calls.)

Ward, S.E., Serlin, R.C., Donovan, H.S., Ameringer, S.W., Hughes, S., Pe-Romashko, K., & Wang, K.K. (2009). A randomized trial of a representational intervention for cancer pain: Does targeting the dyad make a difference? Health Psychology: Official Journal of the Division of Health Psychology, American Psychological Association, 28(5), 588–597.

doi: 10.1037/a0015216
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Study Purpose:

To test the effectiveness of the RIDcancerPain program at overcoming attitudinal barriers to pain management among patients; to determine if the program is more effective when delivered to a patient with a significant other present than to a patient without a significant other present

Intervention Characteristics/Basic Study Process:

Patients were blocked by setting (teaching vs. nonteaching facility) and then randomized to one of three study conditions: the dyad, in which both the patient and a significant other received the educational intervention; the solo condition, in which the patient received the intervention without a significant other present; and the care-as-usual condition. The RIDcancerPain intervention consisted of seven elements:

  1. The patient was asked to describe beliefs regarding the cause, timeline, consequences, cure, and control of cancer pain.
  2. The intervener addressed gaps, confusion, and misconceptions about using analgesics and reporting pain. Those present discussed the issues.
  3. The patient discussed limitations and losses that result from the misconceptions.
  4. The intervener provided information to fill gaps and eliminate confusion, using scripted messages about common attitudinal barriers.
  5. The intervener summarized the benefits of adopting recommendations derived from the information.
  6. The patient created a plan for changing the way he or she managed pain.
  7. During a follow-up telephone consult 2–4 weeks after the first session, the intervener evaluated and revised the coping plan.

In the solo condition, the significant other was asked to leave the room during the intervention. In the dyad condition, the intervention was provided to both individuals. In the care-as-usual condition, project staff answered the questions that participant pairs had about the project. Measurement was done at baseline (T1), at five weeks (T2), and at nine weeks (T3).

Sample Characteristics:

  • The sample was composed of 161 patients.
  • Mean patient age was 58.54 years; age range was 20–85 years. Mean age of significant others was 55.58 years; age range was 18–85 years.
  • Of all patients, 60.2% were female and 39.8% were male.
  • In the dyad group, lung and breast cancers were the most frequent diagnoses; in the solo group, lung, breast, and gastrointestinal cancers were the most frequent; in the control group, gastrointestinal cancer was the most common. Of all patients, approximately 90% were Caucasian. More than 50% of patients had an annual income below $50,000. In the majority of cases, the significant other was the patient's spouse.

Setting:

  • Multisite
  • Outpatient
  • Midwest, United States

Study Design:

Randomized single-blind controlled trial

Measurement Instruments/Methods:

  • Barriers Questionnaire, to measure attitudes about analgesic use
  • Composite score of five items, on a five-point Likert scale, to measure pain severity (Items included amount of time in pain and usual, worse, least, and current pain intensity.)
  • Brief Pain Inventory (Short Form), to measure pain-related interference with activities
  • Functional Assessment of Cancer Therapy-General (FACT-G)
  • European Organization for Research and Treatment quality of life questionnaire QLQ-C30, sections to measure pain relief (0 = no relief, 4 = complete relief)

Results:

  • Before T2, 37 pairs dropped out of the study. Only 124 pairs completed the study through T2. Comparison of dropouts to others showed a significant difference in pain relief ratings (p = 0.02): Those who dropped out had higher pain relief scores.
  • At T2 there were no differences in attitudinal barriers between the two intervention groups.
  • Pain relief change was higher in the dyad condition than in the solo condition (p = 0.008). However, neither group differed significantly from the control group in regard to this outcome.
  • There were no significant differences across study groups in barriers at five weeks. Analysis of variance demonstrated no main effects of the intervention over time. However, authors did note a significant intervention-mediator effect, between baseline and nine weeks, in regard to changes in barrier scores and pain relief (p = 0.026), patient interference (p = 0.003), and negative mood (p = 0.033).

Conclusions:

This intervention did not result in a significant effect regarding pain management or barrier reduction. Whether the patient received the intervention with a significant other present did not seem to affect the result of the intervention.

Limitations:

  • The study had a limitation due to no appropriate control group and no attentional control for the care-as-usual group.
  • The study had a large number of dropouts before completion of measures at nine weeks, so impacts over a long term could not be evaluated.
  • Authors did not examine changes in analgesic medications. Changes in regimen may have affected results.
  • Authors did not provide details about the care-as-usual situation. The report did not cite the amount of education and counseling this group received.

Nursing Implications:

Findings suggest that the authors' hypothesis—that RIDcancerPain intervention changes attitude, which in turn affects pain outcomes—oversimplifies pain management.

Ward, S.E., Wang, K.K., Serlin, R.C., Peterson, S.L., & Murray, M.E. (2009). A randomized trial of a tailored barriers intervention for Cancer Information Service (CIS) callers in pain. Pain, 144(1–2), 49–56.

doi: 10.1016/j.pain.2009.02.021
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Study Purpose:

To test the efficacy of a tailored intervention regarding patient barriers to pain management and pain duration, pain severity, and pain-related interference with daily life

Intervention Characteristics/Basic Study Process:

Patients who called the Cancer Information Service and reported moderate to severe pain were asked to stay on the line and queried about consent for study participation. Consenting participants were randomized to one of three groups: the control group, which responded to a single-item screening measure regarding pain and received no intervention; the assessment-only group, which responded to all baseline assessment measurement tools and provided follow-up outcome measures but received no intervention; or the experimental group, which received the intervention. The intervention consisted of determination of barriers, as measured by a standardized assessment, and delivery of a standardized scripted message relating to each barrier identified. Pain duration, pain severity, pain-related interference with life, and barriers were assessed at baseline, during the initial telephone call, and via a follow-up call approximately 28 days after the intervention. Analysis compared the cost of the intervention to the cost of the assessment-only group. Supervisory staff monitored 10% of calls for general quality control regarding eligibility and invitation to participate. Staff who made the follow-up phone calls, to measure outcomes, were blinded to study-group assignment.

Sample Characteristics:

  • The sample was composed of 1,256 patients who were randomized; 332 patients were in the control group, 332 were in the assessment-only group, and 290 completed the intervention group.
  • Mean patient age was 55.77 years. Age range was 39–89 years.
  • Of all patients, 74.2% were female and 25.1% were male.
  • To be eligible, patients had to state, during the initial telephone interview, that they had at least moderate pain. Of all patients, 63.7% had at least some college-level education; 77.6% were Caucasian and 13.5% were African American.

Setting:

  • Multisite
  • Wisconsin

Study Design:

Randomized three-group study

Measurement Instruments/Methods:

  • Single-item on a five-point Likert-type scale, to measure pain severity
  • Brief Pain Inventory (selected items)
  • Barriers Questionnaire (Short Form)

Results:

  • In regard to barriers, there was no difference between control and assessment-only groups. The targeted intervention group had a significantly lower postintervention barriers score than did the assessment-only group (p = 0.000, d = 0.47).
  • Authors observed no significant differences between groups in regard to pain severity, duration, or interference scores.
  • Barriers scores were used in cost comparisons between the intervention and assessment-only groups. Comparisons revealed no differences in cost-effectiveness between these groups.

Conclusions:

The targeted telephonic intervention had a positive impact on attitudinal barriers to pain management but had no impact on other pain-related outcomes. In regard to effect on barriers, results were similar in the assessment-only and intervention groups.

Limitations:

  • The study had a risk of bias due to no appropriate control group.
  • The study design did not allow authors to determine if changes in other aspects of pain management may have affected results.

Nursing Implications:

Providing telephonic assessment of patient barriers to pain management and information about pain management are effective means of reducing those barriers. The effectiveness of the specified interventions and the effect of barrier reduction on overall pain control and management remains unclear.

Yildirim, Y.K., Cicek, F., & Uyar, M. (2009). Effects of pain education program on pain intensity, pain treatment satisfaction, and barriers in Turkish cancer patients. Pain Management Nursing, 10, 220–228.

doi: 10.1016/j.pmn.2007.09.004
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Study Purpose:

To investigate the effect of a pain education program on pain intensity, satisfaction with pain treatment, and barriers to pain management

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to a group that received the education program or to a control group. Patients in the education group received written materials and an educational slide program. They received a booklet covering the same content as the other components. Content included the definition of pain; a list of its causes; discussion of pain-related pharmacologic treatment, side effects, myths, and misconceptions (e.g., misconceptions about addiction, drug dependence, tolerance); noncompliance; and nonpharmacologic pain treatment and pain assessment. The initial session took 30–40 minutes and was provided to each patient individually, in his or her hospital room. The education session was repeated after three and seven days, as needed. Patients in the control group received standard care and answers to relevant questions but did not receive specialized education. Assessments were done at baseline and at weeks 2, 4, and 8.

Sample Characteristics:

  • The sample was composed of 40 patients.
  • Of all patients, 85% were over age 60.
  • Of all patients, 55% were male and 45% were female.

 

Setting:

  • Single site
  • Inpatient
  • Turkey

Phase of Care and Clinical Applications:

Phase of treatment: active treatment

Study Design:

Randomized controlled study

Measurement Instruments/Methods:

  • McGill Pain Questionnaire 
  • Numeric rating scale
  • Barriers Questionnaire, Revised

Results:

  • Compared to controls at weeks 2, 4, and 8, patients in the education group had a significant decrease in mean scores regarding present pain (p < 0.001), least pain (P < 0.05), and satisfaction with pain treatment (p < 0.001).
  • At the end of week 2, the barriers score decreased significantly in the education group, dropping from 2.12 to 1.29; in the control group, the barriers score decreased from 2.3 to 2.28 (p < 0.001). Compared to controls, patients who received the education had lower barrier scores, in subscales regarding use of analgesics (p = 0.023) and communication related to pain (p = 0.000).

Conclusions:

Pain education was helpful in reducing pain intensity; education improved satisfaction with pain management and reduced barriers to pain management.

Limitations:

  • The study had a small sample, with fewer than 100 patients.
  • The study had a risk of bias due to no attentional control or blinding.
  • Authors provided no information regarding analgesic use or changes in analgesics over the course of the study. Such changes could have influenced results.
  • The individual education session was to have been repeated every 3–7 days as needed. However, authors did not state how many sessions were repeated.
  • Whether patients were in the hospital for the duration of the study, in a controlled environment, is unclear.

Nursing Implications:

Findings suggest that pain education is effective at reducing pain intensity, increasing patient satisfaction, and reducing barriers to pain management. Specifically addressing misconceptions about analgesic use and the need to communicate regarding the pain experience can be expected to help reduce barriers to effective pain management by means of analgesics. Patients' active involvement in their own pain management can improve the quality of this aspect of care.

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