Likely to Be Effective

Mindfulness-Based Stress Reduction

for Sleep-Wake Disturbances

Mindfulness-based stress reduction (MBSR) is a consciousness discipline that is grounded in eastern philosophy and traditions such as yoga and Buddhism, focusing on awareness of the present moment. It aims to teach people to deal more effectively with experience through awareness of feelings, thoughts, and bodily sensations. Participants learn to engage in mindfulness practices such as body scan, simple yoga exercises, and meditation. MBSR has been studied in patients with cancer for its effect on symptoms of anxiety, cognitive impairment, fatigue, sleep-wake disturbances, and depression. It has also been studied in caregivers of patients with cancer for its effect on caregiver strain and burden.

 

Systematic Review/Meta-Analysis

Chiu, H.Y., Chiang, P.C., Miao, N.F., Lin, E.Y., & Tsai, P.S. (2014). The effects of mind-body interventions on sleep in cancer patients: A meta-analysis of randomized controlled trials. Journal of Clinical Psychiatry, 75, 1215–1223.

Purpose

STUDY PURPOSE: To examine the effect of mind-body interventions (MBIs) on sleep quality among patients with cancer, the moderating effects of the intervention components, subject characteristics, and methodologic features of the relationship between MBIs and sleep
 
TYPE OF STUDY: Meta-analysis

Search Strategy

DATABASES USED: PubMed, Cochrane Library, PsycINFO, and CINAHL
 
KEYWORDS: (mind-body intervention OR mindfulness-based stress reduction OR meditation OR yoga OR hypnosis OR breathing training OR exercise OR qigong OR tai chi OR music therapy OR biofeedback) AND (sleep OR sleep disturbance OR sleep quality OR insomnia) AND (cancer)
 
INCLUSION CRITERIA: Prospective, randomized clinical trials (RCTs) in which MBIs were tested to improve sleep; studies with ≥ 10 randomized participants (i.e., adults ≥ 18 years of age diagnosed with cancer); studies accepted or published in English in a peer-reviewed journal 
 
EXCLUSION CRITERIA: Studies without a control group; studies that did not report on a sleep parameter at baseline and after the intervention 

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 114
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two authors developed and used a data extraction sheet with study characteristics, participant characteristics, intervention details, and outcomes. Studies were independently screened. Disagreements were resolved by discussion, and consensuses were reached. The methodologic study quality was assessed by two authors using the Cochrane Handbook for Systematic Reviews of interventions in six key domains. Publication bias was examined using the fail-safe N and Egger tests; results indicated that publication bias was not present.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 15
 
TOTAL PATIENTS INCLUDED IN REVIEW = 1,405
 
SAMPLE RANGE ACROSS STUDIES: 16–410 patients
 
KEY SAMPLE CHARACTERISTICS: Participants were adults ≥ 18 years of age diagnosed with cancer. Ten studies were conducted in patients with breast cancer, and the remaining five studies were conducted in patients with other cancers. Eight RCTs tested yoga; two studies tested mindfulness-based stress reduction, mediation, and hypnosis; one study tested mind-body bridging and Qigong. 

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

The primary outcome was a change in a sleep parameters. The results of the meta-analysis indicated that MBIs had a medium effect size on the improvement of sleep quality, and this effect persisted up to three months after treatment. The weighted mean effect size was -0.43 (95% CI, -0.24 to -0.62), and the long-term effect size (up to three months) was -0.29 (95% CI, -0.52 to -0.06). The sensitivity analysis revealed that MBIs had a significant effect on sleep (g = -0.33, p < 0.001). The moderating effects of components of the intervention, methodologic features, subject characteristics, and the quality of the studies on the relationship between MBIs and sleep were not found (all p values > 0.05). The main interventions used in included studies in which yoga and mindfulness-based stress reduction were employed. Some studies involved the use of meditation, hypnosis, or sleep hygiene interventions. Yoga interventions yielded an effect size similar to that of other individual interventions (g = -0.40, p = 0.71).

Conclusions

This meta-analysis suggested that MBIs yield a medium effect size on sleep quality, and its effects are maintained for up to three months.

Limitations

Although there was a comprehensive review of the literature, the selection criteria may have limited the studies included in the review, and the search strategies may have influenced the articles obtained. Only RCTs with MBIs reporting improved sleep outcomes may have been published, and studies with negative results may have been missed, causing a publication bias. Analysis was only done across all studies, which had substantially different interventions, some of which included cognitive behavioral therapy, which is shown to be effective in sleep improvement. The validity of calculating results across studies with very different interventions is questionable. Different methods of measurement were used in some studies as well. The included studies all lacked attention control.

Nursing Implications

The findings of this meta-analysis support the implementation of MBIs into multimodal approaches to managing sleep quality in patients with cancer; however, it should be recognized that this pooled analysis was done across specific interventions that were very different from each other, and there are multiple limitations that affect the strength of these conclusions.

Print

Christodoulou, G., & Black, D.S. (2017). Mindfulness-based interventions and sleep among cancer survivors: A critical analysis of randomized controlled trials. Current Oncology Reports, 19, 60-017-0621-6.

Purpose

STUDY PURPOSE: Review and critically examine the literature that tests the efficacy of mindfulness-based interventions (MBIs) on sleep outcomes among cancer survivors.

TYPE OF STUDY: General review, "semi" systematic

Search Strategy

DATABASES USED: Not stated

YEARS INCLUDED: (Overall for all databases) 2003-2015

INCLUSION CRITERIA: Randomized controlled trials that examine the efficacy of MBIs on sleep parameters that are primary or secondary outcomes of the study

EXCLUSION CRITERIA: Not stated

Literature Evaluated

TOTAL REFERENCES RETRIEVED: Not stated 

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: A specific appraisal or scoring system was not used, but the discussion addresses methodological strengths and limitations of the studies, including how researchers define sleep problems at baseline, whether sleep was a primary or secondary outcome of the trial, whether participants had completed cancer treatment, characteristics of control groups, and sleep measurement strategies.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: 6

TOTAL PATIENTS INCLUDED IN REVIEW: 695 participants 

SAMPLE RANGE ACROSS STUDIES: 35-336

KEY SAMPLE CHARACTERISTICS: Four trials had samples of breast cancer survivors, and two trials had patients with mixed diagnoses. Five of six trials required patients to have completed treatment, but three trials allowed patients to continue with hormone therapy. Participants in the trials had variable levels of sleep problems (low to high) at baseline.

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care  

APPLICATIONS: Elder care, palliative care

Results

Four of six studies reported improvement in objective and/or subjective sleep measures immediately after the MBI. Three of six studies reported improvement in sleep at follow-up time points (1 month–3 months). Effect sizes were larger when participants had higher levels of sleep problems at baseline. Some trials included sleep as a secondary outcome when the primary outcomes were other conditions, such as depression, anxiety, and distress. It is not known, therefore, whether MBIs improved sleep directly or indirectly through improvement of the primary condition. It is difficult to measure dosage of MBIs.

Conclusions

The benefits of MBIs on sleep problems in cancer survivors are uncertain because of the variability in these trials.

Limitations

Limited search

Limited number of studies included

High heterogeneity

The databases and the search strategy used are unknown. Only 6 studies were included. A specific appraisal system was not used.

Nursing Implications

Mindfulness practices have potential benefits to address a variety of distressing conditions, including cancer-related sleep disturbances. This review of six trials that tested the efficacy of MBIs on sleep disturbances in patients reported mixed results on sleep outcomes, concluding that the research was limited by variability in the trials. The discussion includes recommendations for strengthening this body of research.

Print

Haller, H., Winkler, M.M., Klose, P., Dobos, G., Kummel, S., & Cramer, H. (2017). Mindfulness-based interventions for women with breast cancer: An updated systematic review and meta-analysis. Acta Oncologica, 56, 1665–1676.

Purpose

STUDY PURPOSE: To systematically review the evidence for mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) for women with breast cancer.

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PubMed, MEDLINE, Scopus, Embase, Central

YEARS INCLUDED: No restrictions for time 

INCLUSION CRITERIA: Randomized controlled trials, adults with breast cancer, MBSR or MBCT or variations of each

EXCLUSION CRITERIA: Heterogeneous cancer populations (unless data for breast cancer were reported separately), interventions that were clearly different from MBSR or MBCT

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 608 in initial search, 14 in final analyses

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Appropriate

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: 14 articles on 10 studies 

TOTAL PATIENTS INCLUDED IN REVIEW: 1,709

SAMPLE RANGE ACROSS STUDIES: 44–336

KEY SAMPLE CHARACTERISTICS: Women with mostly nonmetastatic breast cancer, during and after treatment, stage 0–4; mean age ranged from 46.1–58.0 years

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

Small short-term benefit for MBSR or MBCT on health-related quality of life compared to usual care (p = 0.020); the same was found for fatigue (p < 0.00), sleep (p = 0.001), and depression (p < 0.001). Sleep was assessed with the MOS-Ss and the PSQI as well as the sleep subscale of the MDASI. Anxiety outcomes were not included in the meta-analysis.

Conclusions

This was a well-conducted systematic review that identified preliminary evidence that MBSR and MBCT are safe and show short-term effectiveness for quality of life, fatigue, sleep, stress, anxiety, and depression in women with breast cancer. Clinical relevance remains unclear, and future studies should include longer follow-up and more active control conditions.

Nursing Implications

MBSR and MBCT show promise for symptom management in women with breast cancer, but more evidence is needed prior to widespread implementation.

Print

Winbush, N. Y., Gross, C. R., & Kreitzer, M. J. (2007). The effects of mindfulness-based stress reduction on sleep disturbance: a systematic review. Explore (New York, N.Y.), 3, 585–591.

Purpose

To systemically evaluate the evidence regarding the effectiveness of mindfulness-based stress reduction (MBSR) for sleep disturbance.

Search Strategy

Databases searched were MEDLINE, AMED, CINAHL, PsycINFO, The Cochrane Central Register of Controlled Trials, and Digital Dissertations.

Search keywords were mindfulness-based stress reduction, meditation, mindfulness, sleep, and insomnia. The terms mind-body relations and mind-body relaxation techniques were searched in combination with sleep and insomnia. The Cochrane Central Register was searched using the keywords meditation and sleep.

Studies were included if they

  • Were clinical trials, systematic reviews, or meta-analyses
  • Were published in the English language
  • Used MBSR (including several forms of meditation techniques) with multiple treatment sessions and pre- and postintervention assessment of sleep quality and duration.

Studies were excluded if they investigated only one of several modalities of MBSR provided to a treatment group or reported only qualitative outcomes.
 

Literature Evaluated

  • In total, 38 references were retrieved.
  • The first and second author identified and reviewed potentially relevant articles. When necessary, the authors of excluded articles were contacted to confirm nonuse of MBSR interventions.
  • No specific method for evaluating study quality was described.

Sample Characteristics

  • The final number of studies included was seven.
  • The total sample included 423 participants.
  • The sample range across studies was 16 to 115 participants.
  • In all studies included, at least 50% of the participants were women.
  • Seventy-six percent of all participants had at least one medical and one mental health diagnosis.
  • Mean age ranged from 46 to 57 years. 
  • Studies were conducted in patients with cancer (n = 3), patients on sleep medicine (n = 1), patients with fibromyalgia (n = 1), solid organ transplant recipients (n = 1), and patients seen at a community health center (n = 1).
  • All MBSR interventions lasted 8 to 10 weeks and included formal home practice.

Results

Outcome measures included the Pittsburgh Sleep Quality Index (PSQI), sleep diaries, visual analog assessment of sleep quality, and self-reports. Four studies found significant differences in sleep quality from pre- to postintervention. Both studies with control or comparison groups showed no significant differences in sleep quality from pre- to postintervention.  One study that included English- and Spanish-speaking participants demonstrated that English speakers showed more improved sleep quality than Spanish speakers. Two studies found significant differences in sleep quality related to home MBSR practice; however, one study found no significant differences related to practice time.

Conclusions

Given the very mixed results of the included studies, more research is needed to determine the impact of MBSR on sleep quality. Controlled studies that closely adhere to standardized MBSR interventions are necessary to fully describe the effects of MBSR on sleep quality. Comparisons between studies were limited due to the variability of sleep measures used. Studies using well-established and standardized measures of sleep quality are also needed.

Limitations

  • Only one study included a control group.
  • Only one study on patients with cancer was included.

Nursing Implications

Given the mixed results seen and because only one study on patients with cancer was included, this review did not provide strong evidence of the efficacy of MBSR.

Print

Research Evidence Summaries

Andersen, S. R., Würtzen, H., Steding-Jessen, M., Christensen, J., Andersen, K. K., Flyger, H., . . . Dalton, S. O. (2013). Effect of mindfulness-based stress reduction on sleep quality: results of a randomized trial among Danish breast cancer patients. Acta Oncologica (Stockholm, Sweden), 52, 336–344.

Study Purpose

To determine if a mindfulness-based stress reduction (MBSR) intervention improves sleep quality in postoperative patients with breast cancer.

Intervention Characteristics/Basic Study Process

An MBSR intervention was implemented using a standardized MBSR manual and was led by trained instructors. The intervention included eight weekly MBSR group sessions lasting two hours each. Sessions included psychoeducation on stress response, gentle yoga, and mindfulness meditation. No additional content was added in regard to sleep problems. All participants were encouraged to practice MBSR at home for 45 minutes daily and were given CDs and meditation guides for home practice. All participated in a five-hour retreat after week 7. Assessments were performed postintervention and at 6 and 12 months.

Sample Characteristics

  • The study included 336 women in the intention-to-treat (ITT) analysis. The final sample was comprised of 264 women.
  • Mean (standard deviation [SD]) age was 53.9 years (SD = 10.1 years) in the MBSR group and 54.4 years (SD = 10.5 years) in the control group.
  • Participants had breast cancer and were 3 to 18 months postoperative.

Setting

  • Multisite 
  • Denmark

Phase of Care and Clinical Applications

Participants were undergoing the transition phase of care after active treatment.

Study Design

The study was a randomized, controlled trial with repeated measures.

Measurement Instruments/Methods

  • Medical Outcome Study (MOS) Sleep Scale (not validated in patients with breast cancer)
  • Symptom Checklist-90-revised (SCL-90-R)
  • Hot Flush Score (stated as validated, but no further information was provided on validity or reliability)

Results

Sleep quality improved from baseline to postintervention for both groups, with statistically significant differences in mean scores for sleep quality for the MBSR group in two indices of the sleep problem index (p = 0.03). There were no significant differences between groups at the 6- and 12-month follow-ups. Change in overall sleep quality was also significantly better in the MBSR group from baseline to postintervention (p = 0.05) but with a small effect size (<0.3). Further quantile regression analysis revealed that those who participated in MBSR had a significantly smaller increase in sleep disturbances from baseline than the control group in the twenty-fifth percentile, although this effect was not significant across quartiles. The effects of MBSR on sleep quality were not modified by hot flushes or psychological distress.

Conclusions

MBSR has limited short-term but no long-term effects on sleep quality in postoperative patients with breast cancer. Effects on sleep quality are small and are not modified by hot flushes or psychological distress. Further study is needed to determine if MBSR is effective for patients with significant sleep problems immediately after surgery and if booster MBSR sessions have longer-term effects.

Limitations

  • The study had risks of bias due to no blinding and no appropriate attentional control condition.
  • Measurement validity/reliability was questionable.
  • Subject withdrawals were 10% or greater.
  • Of the patients, 7% in the intervention group were either lost to follow-up or discontinued the intervention and about 15% in the control group were lost to follow-up. No analysis of differences was performed on those lost to follow-up and those who continued. Although not statistically significant, baseline sleep disturbance data showed lower results for disturbance in the intervention group, and ITT analysis was the last value carried forward. ITT analysis may have overstated the effects of MSRB in this case.

Nursing Implications

Further study is needed to determine if MBSR is effective for improving sleep quality in patients with breast cancer. Nurses should assess for sleep problems in patients with breast cancer across treatment and especially after treatment.

Print

Carlson, L. E., & Garland, S. N. (2005). Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. International Journal of Behavioral Medicine, 12, 278–285.

Intervention Characteristics/Basic Study Process

The mindfulness-based stress reduction (MBSR) meditation program included relaxation, meditation, gentle yoga, and daily practice. Patients attended eight sessions and received a 52-page booklet with weekly instructions plus an audiotape of the meditations. Outcomes were sleep, mood, stress, and fatigue.

Sample Characteristics

  • The sample was comprised of 63 patients (49 women, 14 men).
  • Mean age was 54 years (range 32–78).
  • Patients had mixed cancer diagnoses and stages.

Setting

  • Outpatient
  • Canada

Phase of Care and Clinical Applications

Patients were undergoing the long-term follow-up phase of care.

Study Design

The study used a prospective, repeated measures, quasiexperimental, feasibility design with one group.

Measurement Instruments/Methods

Pittsburgh Sleep Quality Index (PSQI)

Results

At pretreatment, 91% of the sample had a PSQI of 5 or more and 51% had a score of 10 or more. At posttreatment, 27% reported a PSQI of greater than 10. Sleep disturbance was significantly reduced, and subjective sleep quality was improved.

Limitations

  • The study lacked a control or comparison group; also, only a subjective sleep measurement was used. The relative importance of different components of the intervention is not known.
  • Training in delivering the intervention is needed.
  • Cost is incurred for a space for the class and for an instructor.

 

Print

Carlson, L. E., Speca, M., Patel, K. D., & Goodey, E. (2003). Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosomatic Medicine, 65, 571–581.

Intervention Characteristics/Basic Study Process

The mindfulness-based stress reduction (MBSR) meditation program included relaxation, meditation, gentle yoga, and daily practice. Patients received a 52-page booklet with weekly instructions and an audiotape of the meditations. Patients attended eight weekly, 90-minute group sessions plus a three-hour silent retreat on Saturdays on weeks 6 and 7. Outcomes were quality of life (QOL), mood, symptoms of stress, and immune and hormone parameters.

Sample Characteristics

  • Pretest, the sample was comprised of 59 patients (49 patients with stage 0, I, or II breast cancer and 10 with early stage prostate cancer).
  • Posttest, the sample was comprised of 42 patients.

Setting

  • Outpatient
  • Canada

Phase of Care and Clinical Applications

Patients were undergoing the long-term follow-up phase of care.

Study Design

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

Measurement Instruments/Methods

European Organisation for Research and Treatment of Cancer Quality of Life Questionnare (EORTC QLQ-C30) sleep disturbance subscale

Results

Significant improvements were reported in sleep quality.

Limitations

  • The study lacked control of the comparison group.
  • The relative importance of different components of the intervention is not known. Improvement in sleep was not correlated with the degree of program attendance or minutes of home practice.
  • Training in delivering the intervention is needed.
  • Cost is incurred for a space for the class and an instructor.
Print

Garland, S.N., Carlson, L.E., Stephens, A.J., Antle, M.C., Samuels, C., & Campbell, T.S. (2014). Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: A randomized, partially blinded, noninferiority trial. Journal of Clinical Oncology, 32, 449–457. 

Study Purpose

To examine whether mindfulness-based stress reduction (MBSR) is noninferior to cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia in patients with cancer

Intervention Characteristics/Basic Study Process

CBT-I was delivered to groups of 6–10 individuals over the course of eight weekly, 90-minute sessions for a total of 12 contact hours. The intervention followed the format of previously published CBT-I trials in patients with cancer. CBT-I contains the following four individually validated strategies: stimulus control, sleep restriction, cognitive therapy, and relaxation training, which target and reduce sleep-related physiologic and cognitive arousal to re-establish restorative sleep function.
 
MBSR was delivered to groups of 15–20 people over the course of eight weekly, 90-minute sessions, plus one six-hour, weekend, intensive silent retreat for a total of 18 contact hours. The program provides patients with psychoeducation on the relationship between stress and health, while meditation techniques and gentle yoga are practiced to support the development of mindful awareness and responding to stress.

Sample Characteristics

  • N = 111  
  • MEAN AGE = 58.89 years (SD = 11.08 years)
  • AGE RANGE = 35–88 years
  • MALES: 28%, FEMALES: 72%
  • KEY DISEASE CHARACTERISTICS: Patients with mixed nonmetastatic cancer who had insomnia and completed primary treatment at least one month prior; 48% had breast cancer, and 12% had prostate cancer; mean cancer duration was 3.9 years (SD = 4.03 years); treatments included surgery, chemotherapy, radiation, and hormonal therapy
  • OTHER KEY SAMPLE CHARACTERISTICS: Mean education was 15.14 years (SD = 3.53 years); 90% white/European

Setting

  • SITE: Single site    
  • SETTING TYPE: Tertiary cancer center    
  • LOCATION: Calgary, Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Long-term survivorship (at least one month since active, primary treatment)

Study Design

  • Randomized, partially blinded, noninferiority trail
 

Measurement Instruments/Methods

  • Insomnia Severity Index (ISI)
  • Daily sleep diaries
  • Actigraph GT1M
  • Calgary Symptoms of Stress Inventory
  • Profile of Mood States (POMS)
  • Dysfunctional Beliefs and Attitude About Sleep (DBAS)

Results

Of 327 patients screened, 111 were assigned randomly (CBT-I, n = 47; MBSR, n = 64). MBSR was inferior to CBT-I for improving insomnia severity immediately after the program (p = .35), but MBSR demonstrated noninferiority at follow-up (p = .02). Sleep diary-measured sleep latency (minutes to fall asleep) was reduced by 22 minutes in the CBT-I group and by 14 minutes in the MBSR group at follow-up. Similar reductions in wake after sleep onset (in minutes) were observed for both groups. Total sleep time increased by 0.60 hours for CBT-I and 0.75 hours for MBSR. CBT-I improved sleep quality (p = .001) and dysfunctional sleep beliefs (p = .001), whereas both groups experienced reduced stress (p = .001) and mood disturbance (p = .001).

Conclusions

Although MBSR produced a clinically significant change in sleep and psychological outcomes, CBT-I was associated with rapid and durable improvement and remains the best choice for the nonpharmacologic treatment of insomnia.

Limitations

  • Risk of bias (no appropriate attentional control condition)
  • Findings not generalizable
  • Other limitations/explanation: The most notable limitation is the differential attrition observed between groups. Although the reasons are unknown, participant preference may have contributed to the significant attrition in the MBSR group compared with CBT-I because how learning meditation and yoga could contribute to sleep improvements may be less obvious to participants not already inclined to choose MBSR. The findings are not generalizable to a more racially diverse population (90% white/European). The absence of a no-treatment control group prevents an exploration of alternate explanations for change over time. The additional six hours of contact time received by participants in the MBSR group raises the possibility of even greater relative improvement for the CBT-I group if it had been matched for time. Treatment integrity was not formally assessed; however, the research was designed to minimize risk of treatment contamination, and measures were taken throughout the study to promote fidelity.

Nursing Implications

Noninferiority of MBSR only was demonstrated at the five-month follow-up, suggesting that although MBSR may produce clinically significant improvements with time, the treatment effects of CBT-I are rapid and durable. Thus, CBT-I remains the treatment of choice for patients with cancer who have insomnia.

Print

Johns, S.A., Brown, L.F., Beck-Coon, K., Talib, T.L., Monahan, P.O., Giesler, R.B., . . . Kroenke, K. (2016). Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors. Supportive Care in Cancer, 24, 4085–4096.

Study Purpose

To compare mindfulness-based stress reduction (MBSR) with psychoeducation/support groups (PES) as interventions to treat cancer-related fatigue (CFR) and associated symptoms of anxiety, depression, vitality, sleep disturbances, and pain. An active treatment control group (PES) was used to determine the effect size of MBSR in reducing CRF.

Intervention Characteristics/Basic Study Process

Breast cancer survivors (BCSs) and colorectal cancer survivors (CRCSs) were blinded and randomized into the MBSR group or the PES intervention. The primary outcome was CRF interference, and secondary outcomes of CRF were severity, vitality, anxiety, depression, sleep disturbances, and pain at baseline (T1), postintervention (T2) and at six months postintervention (T3). Both arms of the study included a structured curriculum that lasted two hours weekly for eight weeks. As the MBSR cohort had required exercises and practice assigned between classes, the PES arm was also given between-session practice and supplemental readings related to class topics. Treatment fidelity to each of the interventions was maintained by use of standardized manuals for each (MBSR and PES), audio recordings of the sessions with review by investigators using checklists created to evaluate the interventions. The MBSR intervention was adapted from standard approaches to eliminate the use of a retreat, the addition of psychoeducation, a brief body scan at bedtime, and shorter home practices. The PES program incorporated group discussions.

Sample Characteristics

  • N = 69   
  • MEAN AGE = BCS: 56.9 years (SD = 9.9 years), CRCS: 56.4 years (12.7 years)
  • MALES: 9.9%, FEMALES: 90.1%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Adults aged 18 years or older with nonmetastatic (stage 0–III) BCSs or CRCSs who reported CRF as 4 or greater on the Fatigue Symptom Inventory (FSI)
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants had completed active treatment an average of 2.4 years prior to the study and were predominantly Caucasian (70.4%). Forty-six percent of the BCSs were on endocrine therapy at the time of the study, and the only statistically significant difference between groups at baseline was income (p = 0.07).

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: National Cancer Institute–designated comprehensive cancer center clinics

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Single-blind, two-armed, randomized clinical pilot trail

Measurement Instruments/Methods

  • FSI
  • SF-36 Vitality Scale
  • Patient Health Questionnaire-8 (PHQ-8)
  • Generalized Anxiety Disorder-7 scale
  • Patient Health Questionnaire-9 (PHQ-9) for depression 
  • Insomnia Severity Index
  • PEG three-item abbreviated version of the Brief Pain Inventory (BPI)
  • Global Improvement in Fatigue measure was a single item asking participants to rate their CRF compared to the beginning of the study.

Results

The primary outcome of CRF interference did not significantly differ between MBSR and PES, although a trend (insignificant) toward MBSR was observed at T2 (d = –0.46, p = 0.073). Secondary outcome of vitality demonstrated moderate and significant effect size in the MBSR arm compared to the PES arm (d = 0.53, p = 0.003) at T2; however, the between group difference did not last through the T3 measurement. The MBSR maintained improvement in vitality, whereas vitality improved in the PES group. In addition, at T2, the MBSR participants were significantly more likely to report CRF global improvement (58.8 versus 34.3%, respectively, X2 (1) = 4.176, p = 0.041). Both groups continued to report similar global improvements in CRF at T3 (MBSR = 45.5 versus PES = 54.3%, X2 (1) = 0.53, p = 0.467). Pain was the only between group secondary outcome in which MBSR demonstrated moderate and significant improvement at T3 compared to PES (d = –0.50, p = 0.014).

Within group effects: Both MBSR and PES participants demonstrated moderate to large effects and significant improvements on all fatigue outcomes at T2 and T3 compared to T1. Participants in both groups also reported moderate to large effects and significant improvements at T2 and T3 from baseline in depression (p < 0.001), anxiety (p < 0.001), and sleep disturbance (p < 0.001).

Conclusions

Although the aim of this study was to rigorously test MBSR as an intervention for CRF in preparation for a phase-III randomized, controlled trial, the study supported the strength of PES as an intervention as well.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (sample characteristics)
  • Findings not generalizable

Nursing Implications

Although MBSR has been shown an effective intervention for numerous cancer-related symptoms, including CRF, a structured PES intervention was also clearly effective in helping survivors manage fatigue and other symptoms. However, given the more immediate effect of MBSR for participants, MBSR may provide results sooner. Both interventions are efficacious and therefore provide cancer survivors a choice in interventions effective in reducing CRF and its interference in daily life through anxiety, depression, and sleep disturbance.

Print

Lengacher, C.A., Reich, R.R., Paterson, C.L., Jim, H.S., Ramesar, S., Alinat, C.B., . . . Kip, K.E. (2015). The effects of mindfulness‐based stress reduction on objective and subjective sleep parameters in women with breast cancer: A randomized controlled trial. Psycho‐Oncology, 24, 424–432.

Study Purpose

To investigate the effects of mindfulness-based stress reduction (MBSR) on sleep parameters in women with breast cancer

Intervention Characteristics/Basic Study Process

Patients were randomized to the MBSR group or a usual care wait-list control group. MBSR was delivered in two-hour weekly sessions six times, including educational materials related to relaxation, meditation, healthy lifestyle, practice of meditation, yoga, body scan and walking meditation, and supportive group interaction and discussion. Patients were asked to practice meditative techniques 15–45 minutes daily. Study measures were obtained at baseline, six weeks, and 12 weeks.

Sample Characteristics

  • N = 79–77 (completed 12 weeks)
  • MEAN AGE = 57 years (SD = 9.7 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All patients were diagnosed with breast cancer and had completed initial treatment within two weeks to two years previously. All had surgery. About half had stage 3 or 4 disease.
  • OTHER KEY SAMPLE CHARACTERISTICS: 73% Caucasian; 59,5% married; 80% had at least some college or vocational education; 40% had an income of $40,000 or more; 30% were employed more than 32 hours per week

Setting

  • SITE: Multi-site
  • SETTING TYPE: Outpatient  
  • LOCATION: Florida, United States

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • ActiGraph
  • Pittsburgh Sleep Quality Index (PSQI)
  • Sleep diary for 72 hours after each study assessment

Results

From baseline to six weeks, there were no differences between the groups. From 6–12 weeks, there were improvements in the MBSR group in sleep efficiency and the number of times patients awoke as measured by actigraphy (between groups Cohen’s d = 0.33 – 0.38; p = 0.04; p < 0.01). There were no differences between groups in PSQI or sleep diary findings. Sleep efficiency, the percent of time per night in sleep, was 78.2% in the MBSR group compared to 74.6% in the control group. All sleep parameters improved in both groups. There was no correlation between how much individuals practiced and sleep outcomes.

Conclusions

The use of MBSR resulted in improvements in some sleep parameters.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Unintended interventions or applicable interventions not described that would influence results
  • Other limitations/explanation: No information was provided as to whether any patients were receiving other sleep-related interventions or medications. Compliance with actigraphy, home practice, and diary use was not clear. A 4% difference in sleep time was statistically significant and had a moderate effect size, but one might question if this is clinically relevant as well. It is not clear whether the six weekly sessions were given in the first six weeks or conducted every other week over the entire course of the study. Baseline sleep efficiency scores were 80%, suggesting there may be a ceiling effect in measure as well as a testing effect with repeated use of the PSQI.

Nursing Implications

The findings of this study suggest that MBSR as provided in this intervention might improve some sleep parameters compared to usual care control patients; however, sleep parameters did improve over time in all participants. This is a low-risk type of intervention, but it involves multiple sessions delivered in person. It is not known whether different delivery methods can be successful, what the appropriate and necessary timing should be, or what the frequency and duration of the delivered interventions should be.

Print

Lengacher, C. A., Reich, R. R., Post-White, J., Moscoso, M., Shelton, M. M., Barta, M., . . . Budhrani, P. (2012). Mindfulness based stress reduction in post-treatment breast cancer patients: an examination of symptoms and symptom clusters. Journal of Behavioral Medicine, 35, 86–94.

Study Purpose

To compare the prevalence and severity of symptoms and symptom clusters in patients with breast cancer who participated in a mindfulness-based stress reduction (MBSR) program to the symptoms and symptom clusters in patients who received usual care.

Intervention Characteristics/Basic Study Process

Women who expressed interest in participating in the study were randomly assigned to MBSR or usual care. The MBSR program lasted six weeks and included educational material, meditation practice in weekly group settings and homework, group discussion on barriers to meditation, application of mindfulness in daily life, and group support interactions. Meditation training consisted of sitting and walking meditation, body scan, and gentle Hatha yoga. Researchers obtained study measures at baseline and within two weeks of program conclusion. Hierarchical-cluster analysis was used to identify symptom clusters. Researchers compared each group's symptom clusters and individual symptoms to those of the other group.

Sample Characteristics

  • In total, 84 participants (100% female) were included.
  • Mean patient age was 58 years (standard deviation = 9.4 years).
  • Median time since diagnosis of breast cancer was 11 to 15 weeks.
     

Setting

  • Single site
  • Outpatient
  • Florida

Study Design

This was a randomized, controlled trial.

Measurement Instruments/Methods

MD Anderson Symptom Inventory

Results

Severity of symptoms declined in both groups from baseline to the end of the study. Fatigue and drowsiness declined more in the MBSR group (p = 0.05). Interference scores for mood and relationships also declined more in the MBSR group (p ≤ 0.05). Analysis of changes in symptom clusters showed no differences between groups. Clusters identified were gastrointestinal (nausea, vomiting, anorexia, shortness of breath, dry mouth, numbness), cognitive or psychological (distress, sadness, pain, remembering), and fatigue (fatigue, disturbed sleep, drowsiness). Cluster scores declined in both groups.

Conclusions

Findings suggested that MBSR interventions may benefit women with breast cancer who are managing fatigue or mood.

Limitations

  • The study had a small sample size, with less than 100 participants.    
  • Baseline sample/group differences were of import.
  • The study had risks of bias due to no blinding and no appropriate attentional control condition.
  • The control group included significantly more black patients than did the MBSR group. Ethnic and cultural differences could impact the findings.
  • The study did not state whether any patients were receiving antitumor treatment or if any patients had undergone surgery.
  • The gastrointestinal cluster did not make clinical sense as a cluster. 
  • Enrollment occurred by means of patient self-selection.
  • Symptom severity scores at baseline were low in all patients (less than 4 on a 10-point scale).
 

Nursing Implications

Findings suggested that MBSR may be helpful, to some patients with breast cancer, as a means of combating fatigue and mood changes. Study limitations limited the strength of these findings.

Print

Nakamura, Y., Lipschitz, D. L., Kuhn, R., Kinney, A. Y., & Donaldson, G. W. (2013). Investigating efficacy of two brief mind-body intervention programs for managing sleep disturbance in cancer survivors: a pilot randomized controlled trial. Journal of Cancer Survivorship, 7, 165–182.

Study Purpose

To determine the effects of mindfulness meditation (MM) and mind-body bridging (MBB) on self-reported sleep disturbance and quality of life (QOL) in cancer survivors.

Intervention Characteristics/Basic Study Process

All interventions lasted for three consecutive weeks, with weekly two-hour sessions. The sleep hygiene education (SHE) group served as an active control group. No usual care group was included.

  • MBB:  MBB is used to learn awareness skills that can help individuals recognize and change dysfunctional mind-body states. Sessions included training on identifying aspects of a mind-body state that might be contributing to poor sleep and learning skills of MBB (stress reduction and increasing self-awareness). Participants were encouraged to practice skills learned on a daily basis.
  • MM:  The program content was adapted from a six-week format and included sessions on forms of MM (awareness, body scans, walking meditation, and forgiveness meditation). Concerns about sleep were discussed in the context of MM techniques. Participants were encouraged to practice MM daily and were given mindfulness-based stress reduction (MBSR) meditation CDs and other handouts on MM and stress reduction. No actual homework sheets or practice tracking was required. One expressive writing assignment was completed.
  • SHE:  Education was pasted on the Huntsman Online Patient Education (HOPE) Guide and provided information about how to change sleep habits to improve sleep quality. Regular adherence to the guidelines provided was encouraged.

Sample Characteristics

  • The sample was comprised of 57 patients (24.5% male, 75.5% female).
  • Mean age was 52.6 years.
  • Participants were survivors of any type of cancer.
  • Participants were included if they had completed therapy at least three months prior to participation and had a report of sleep disturbance indicated by a score of 35 or greater on the Medical Outcomes Study Sleep Scale Index II subscale (MOS-SS, SPI-II).
  • Participants with prior experience with MM, MBB, MBSR, or mindfulness-based cognitive therapy were excluded.

Setting

  • Single site 
  • Other
  • Cancer Wellness House (nonprofit organization)

Phase of Care and Clinical Applications

Participants were undergoing the late effects and survivorship phase of care.

Study Design

This was a three-arm, randomized, controlled pilot study.

Measurement Instruments/Methods

  • MOS-SS, SPI-II
  • Functional Assessment of Cancer Therapy–General (FACT-G)
  • Perceived Stress Scale (PSS)
  • Center for Epidemiologic Studies Depression Scale (CESD)
  • Impact of Event Scale (IES)
  • Five-Facet Mindfulness Questionnaire
  • Self-Compassion Scale (SCS)
  • World Health Organization (WHO) Well-Being Index
  • Positive and Negative Affect Schedule (PANAS)
  • Screening and demographic questionnaire

Results

Baseline measurements of sleep differed significantly across groups at baseline (p = 0.011); adjusted baseline scores were used in the analysis. All intervention groups showed significant improvements in sleep quality from baseline (p < 0.001), although no immediate improvement was seen at  weeks 2 or 3 of any intervention arm. MM and MBB were effective longer after the intervention than SHE. FACT-G scores improved significantly from baseline in all groups (MBB:  p = 0.002; MM:  p = 0.010), although no significant difference was revealed in improvement across groups. Mean PSS scores decreased in all groups from baseline but with no significant difference across groups. All three arms had decreased CESD scores (SHE:  p = 0.001; MMB:  p = 0.008; MM:  p = 0.064), with MBB being more effective than SHE in reducing self-reported symptoms of depression (p = 0.040). MBB, but not MM, was also more effective at increasing mindfulness over SHE. Although scores improved for other secondary outcomes, there were no significant differences between groups.

Conclusions

MBB, SHE, and MM may improve sleep quality in cancer survivors. In addition, MBB may improve depressive symptoms and other comorbidities in this population.

Limitations

  • The study had a small sample size, with less than 100 patients.
  • Baseline sample/group differences were of import.
  • The study had risks of bias due to no control group, no blinding, and the sample characteristics.
  • Key sample group differences could have influenced the results.
  • Measurement validity/reliability was questionable.
  • Effects of MM may not have been apparent after only three weeks (this is typically a six- to eight-week program).
  • The study relied on self-report measures.
  • Patients were not evaluated for specific sleep disorders.
  • No measurement of intervention fidelity was reported. 
  • All groups showed improvement; without comparison to a study group with no intervention, efficacy of any of these interventions cannot be readily determined.

Nursing Implications

Simple targeted interventions may be effective in improving sleep quality in cancer survivors. Nurses should be aware of and assess for sleep disturbances in cancer survivors. Further study of interventions for sleep disturbance are needed to improve QOL for this population. Findings from this study suggest that the interventions studied here are feasible; however, the effectiveness of these interventions cannot be determined.

Print

Shapiro, S. L., Bootzin, R. R., Figueredo, A. J., Lopez, A. M., & Schwartz, G. E. (2003). The efficacy of mindfulness-based stress reduction in the treatment of sleep disturbance in women with breast cancer: an exploratory study. Journal of Psychosomatic Research, 54, 85–91.

Intervention Characteristics/Basic Study Process

The intervention consisted of six weekly, two-hour sessions and a one-hour silent treatment session. Participants were trained in meditative practices (Kabat-Zinn), sitting meditation, body scan, Hatha yoga, and “Loving Kindness” meditation.

Participants were given didactic material on physical and psychological effects of stress and tools to cope with stress. The control group chose a stress management technique to engage in each week and used a workbook and diary.

The outcome was sleep.

Sample Characteristics

  • The sample was comprised of 63 women with a history of stage II breast cancer (free-choice control group, n = 32; mindfulness-based stress reduction [MBSR] group, n = 31). 
  • Mean age was 57 years (range 18–80).
  • The women were working, retired, or on disability.

Setting

  • Participants’ homes
  • Western United States

Phase of Care and Clinical Applications

Participants were undergoing the long-term follow-up phase of care.

Study Design

The study was a randomized, controlled trial.

Measurement Instruments/Methods

Sleep diary and a daily diary to record the activities they engaged in for stress management

Conclusions

Hypotheses:

  • Sleep function is associated with psychological distress:  confirmed
  • Sleep efficiency would be improved after controlling for baseline distress:  not confirmed
  • Sleep efficiency and sleep quality would improve with MBSR:  partially confirmed

Limitations

  • The study lacked compliance with the practice of mindfulness techniques; the control group was given too much leeway in their choice of activities to reduce stress.
  • Patients self-reported in sleep diaries.
  • Personnel trained in Kabat-Zinn and Hatha yoga are needed.
Print