Ercoli, L.M., Petersen, L., Hunter, A.M., Castellon, S.A., Kwan, L., Kahn-Mills, B.A., . . . Ganz, P.A. (2015). Cognitive rehabilitation group intervention for breast cancer survivors: Results of a randomized clinical trial. Psycho-Oncology, 24, 1360–1367.
The purpose was to evaluate the efficacy of a cognitive rehabilitation intervention on self-report of cognitive dysfunction, performance on neuropsychological tests, and brain functioning.
Five weekly, manualized, two-hour sessions included two difficulty levels of in-class cognitive training and three levels of homework exercises that were designed to build skills in the targeted areas of attention, executive function, and memory. Participants were encouraged to do four 20-minute sessions of homework exercises per week. Participants received a training manual workbook, auditory exercises CDs, answer keys, and a stopwatch. In-class education also included instruction on coping strategies to minimize anxiety (e.g., deep breathing, relaxation, pacing, countering negative thoughts). Goal attainment was discussed during the group sessions to facilitate setting individual short-term and long-term goals. These specific intervention details were published in 2013 with the results of the single-arm pilot study and not iterated in the 2015 article. Neurocognitive testing, self-report instruments, and qEEG (substudy) were administered at baseline (T0), within one week (T1), and two (T2) and four (T3) months from completing the intervention.
PHASE OF CARE: Late effects and survivorship
Randomized, wait-list controlled, interventional study. Powered on previous single-arm pilot study. Used block randomization (2:1). Intent-to-treat analyses
CNS vital signs computerized testing platform
Rey Auditory Verbal Learning Test (RAVLT)
Brief Visuospatial Memory Test, Revised
Verbal fluency test
Trail Making Tests A and B
Paced Auditory Serial Addition Test
Wechsler Test of Adult Reading (WTAR)
Patient’s Assessment of Own Functioning Inventory (PAOFI)
Beck Depression Inventory, 2nd edition (BDI-II)
Awake and resting state quantitative electroencephalography (qEEG)
Improvement in PAOFI total scores and memory scale scores were significant for the intervention group (p = 0.01, Effect size (ES) 0.90 and 1.10 respectively). The intervention group improved on RAVLT total scores (trials I-V, p = 0.02, ES = 0.57) and delayed recall (p = 0.007, ES = 0.29). Both groups improved on BDI-II scores at T2 and T3 without significant group differences. The qEEG substudy demonstrated intervention group changes (T1 to T2) for global absolute delta power (p = 0.02) and absolute alpha power (AP, p = 0.04). Decreased delta power did not predict PAOFI improvement at T2 (p = 0.971), nor did increased AP (p = 0.137). However, increased AP predicted improved self-report of cognitive dysfunction at T3 (p = 0.012), even controlling for age and IQ (p = 0.011).
The intervention was associated with improved self-report of cognitive function and neuropsychological test performance sustained up to two months. The qEEG substudy demonstrated preliminary evidence of an overall decrease in delta power and increase in AP for the intervention group, suggesting qEEG may serve as a biomarker of intervention efficacy.
Study findings provided further evidence that cognitive rehabilitation is beneficial to improving perceived and actual cognitive function in breast cancer survivors. qEEG may be promising as an early biomarker of intervention effectiveness.
Treanor, C.J., McMenamin, U.C., O'Neill, R.F., Cardwell, C.R., Clarke, M.J., Cantwell, M., & Donnelly, M. (2016). Non-pharmacological interventions for cognitive impairment due to systemic cancer treatment. Cochrane Database of Systematic Reviews, 8, CD011325.
STUDY PURPOSE: To determine the effectiveness of nonpharmacologic interventions for minimizing chemotherapy-induced cognitive impairment in adult patients with breast cancer.
TYPE OF STUDY: Systematic review
DATABASES USED: MEDLINE, Embase, PubMed, CINAHL, PsycINFO, and CENTRAL (Cochrane Centre Register of Controlled Trials)
YEARS INCLUDED: (Overall for all databases) 1980 through September 29, 2015
INCLUSION CRITERIA: Randomized controlled trials evaluating the effectiveness of nonpharmacologic interventions on maintaining or improving cognitive function in cancer survivors who completed chemotherapy (including those currently on hormonal therapy)
EXCLUSION CRITERIA: Studies involving participants with primary or metastatic central nervous system (CNS) disease, nonmelanoma skin cancer, and/or patients in nursing home or residential care settings
TOTAL REFERENCES RETRIEVED: 255 screened (plus 47 additional records), but 40 assessed for study eligibility
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane risk of bias tool was utilized to evaluate study quality.
FINAL NUMBER STUDIES INCLUDED: 5
TOTAL PATIENTS INCLUDED IN REVIEW: 235
SAMPLE RANGE ACROSS STUDIES: 100% female; all patients received chemotherapy and/or hormonal therapy
KEY SAMPLE CHARACTERISTICS: Breast cancer survivors
PHASE OF CARE: Transition phase after active treatment
Five randomized clinical trials compared an intervention with wait-list controls to improve various cognitive functions (i.e., memory, information processing speed [IPS], executive functioning [EF]). Nonpharmacologic interventions included cognitive behavioral therapy (n = 1), cognitive training (n = 2), meditation through Tibetan sound therapy (n = 1), and aerobic exercise (n = 1).
Although cognitive training and cognitive behavioral therapy may be beneficial in improving cognitive functioning, there is insufficient evidence for exercise and meditation. The overall quality of the evidence was determined to be low for all studies included.
Findings from this study revealed that there is insufficient good-quality evidence to determine whether cognitive training, cognitive behavioral interventions, exercise, or meditation may improve cognitive functioning in breast cancer survivors who have received chemotherapy with or without hormonal therapy. However, cognitive training and cognitive behavioral interventions were associated with improvements in objective and subjective measures of cognitive function, so further research including multisite studies with large sample sizes and higher-quality evidence may confirm their effectiveness. Further studies are needed to determine whether exercise and/or meditation might have a role in alleviating cognitive impairment.
Limited number of studies included
Mostly low quality/high risk of bias studies
Study findings do not support recommending cognitive training, cognitive behavioral interventions, exercise, or meditation for improving cognitive impairment in breast cancer survivors. However, additional research using these interventions are recommended to further determine their effectiveness.
Rao, R.M., Vadiraja, H.S., Nagaratna, R., Gopinath, K.S., Patil, S., Diwakar, R.B., . . . Nagendra, H.R. (2017). Effect of yoga on sleep quality and neuroendocrine immune response in metastatic breast cancer patients. Indian Journal of Palliative Care, 23, 253–260.
The purpose of this study was to test the effects of a yoga program to determine impact on perceived stress, sleep, diurnal cortisol, and natural killer cell counts in patients with metastatic cancer compared to education and supportive therapy sessions.
Patients with advanced metastatic breast cancer were recruited from a comprehensive cancer center in the medical and radiation outpatient clinics. Consenting patients were randomized to yoga or supportive therapy groups. Providers of oncology care were blinded to group assignment. The yoga program intervention included two sessions a week for 12 weeks. Each session started with a lecture and yoga for 10 minutes followed by 20 minutes of low-impact yoga postures, breathing, and pranayama and relaxation. Then, subjects completed 30 minutes of guided yoga practice by one of two trained instructors. Practicing was encouraged between sessions with instructions and booklets documented in diary logs. The control group completed supportive care sessions, including education and reinforcing social support. Introductory sessions were 60 minutes before starting treatment and during each treatment visit for 15 minutes. Participants could contact counselors at any time with issues or questions. Diary logs were also completed.
Two-arm, prospective randomized control trial
The Pittsburgh Insomnia Rating Scale was used to measure distress related to sleep, sleep parameters, and sleep-related quality of life. Salivary cortisol was measured using oral swab on three consecutive days at three time points. Natural killer cells were collected at baseline and at the end of the study using serum samples to determine immune response. A daily diary was used to document yoga practice in the intervention group and control group.
Of the 91 baseline participants, complete data were analyzed on 66. Reasons for high dropout were listed. No demographic group differences were noted at baseline. Within-group findings included significant decreased distress scores (p = 0.004), decreased sleep distress scores (p = 0.01), improved sleep quality-of-life scores (p = 0.006), improved sleep total distress scores (p = 0.002), decrease in cortisol (p = 0.03), and natural killer cells (p < 0.01) in the yoga group alone. Intervention adherence was 80% attending 24 supervised sessions. Attending more than 20 sessions showed the decreased 9 am cortisol level in the yoga intervention group.
There was evidence to support that yoga could be impacting sleep distress, sleep outcomes, and sleep quality of life, as well as neuroendocrine immune changes providing mechanistic information regarding the benefits of yoga on sleep. Additional research is needed to generalize findings to a wider cancer population.
When recommending yoga as an intervention for sleep, there is a potential impact on subjective sleep outcomes, quality of life, and neuroendocrine responses such as immune function and cortisol levels.
Chaoul, A., Milbury, K., Spelman, A., Basen-Engquist, K., Hall, M.H., Wei, Q., . . . Cohen, L. (2018). Randomized trial of Tibetan yoga in patients with breast cancer undergoing chemotherapy. Cancer, 124, 36–45.
The purpose was to conduct a randomized control clinical trial examining the effects of a Tibetan yoga program compared to stretching and usual care group on sleep and fatigue among patients with breast cancer receiving chemotherapy.
Upon consent, patients completed a seven-day baseline assessment using actigraphy. At completion of baseline, patients were randomized to one of three treatment groups: Tibetan yoga, stretching, or usual care using adaptive randomization, minimization (age, stage of disease, time since diagnosis, baseline fatigue scores, menopausal status, surgical history, and chemotherapy regimen). Tibetan yoga and stretching groups attended four classes with trained instructors that ranged from 75 to 90 minutes each during chemotherapy. Patients then received three in-home booster sessions over six months. During the entire trial, patients were encouraged to practice at home. Long-term follow-up assessments were completed at 1 week and 3, 6, and 12 months postintervention. The usual care group was instructed not to perform yoga during the study period but given the opportunity to participate in yoga classes at the end of the study.
PHASE OF CARE: Multiple phases of care
Randomized controlled trial
Of the 352 that completed baseline, 74 were randomized to yoga group, 68 to the stretching, and 85 to the wait-list. There were no group differences noted in demographics in the three sample groups. The dropout rate in each group was similar. PSQI global sleep scores were significantly lower in participants who completed the intervention (p = 0.04). The majority of patients in both intervention groups completed all sessions (73% yoga, 74% stretching). No group differences were noted on completeness and practice in both groups. For main outcomes, no significant differences in sleep or fatigue were noted between groups over time. Within-group differences were noted with PSQI sleep disturbances, where the yoga group had significantly lower disturbances after week 1 postintervention compared to stretching (p = 0.03) and usual care (p=0.02). Actigraphy data showed reduced wake after sleep onset (in minutes) for yoga compared to stretching (p = 0.0003) and usual care (p = 0.0002).
The completion of four sessions of Tibetian yoga provided short-term reduction in subjective and objective sleep outcomes compared to stretching but not to usual care. Practicing outside of the intervention setting showed better outcomes in sleep. There was also support to ensure that yoga instruction occurred in-person to maximize patient outcomes and benefit.
Outcomes from this trial provide nurses with additional evidence that yoga could be beneficial for sleep-wake disturbances. However, the results are viewed with caution as the intervention did not show significant improvement compared to usual care.
Tabatabaee, A., Tafreshi, M.Z., Rassouli, M., Aledavood, S.A., AlaviMajd, H., & Farahmand, S.K. (2016). Effect of therapeutic touch on pain related parameters in patients with cancer: A randomized clinical trial. Materia Socio-Medica, 28, 220–223.
The purpose was to evaluate the effects of therapeutic touch (TT) for pain management.
Patients were randomly assigned to TT, placebo, or control groups. TT was provided by a trained therapist in a private area every three days for seven sessions. In the placebo group, hands were placed around the body in a sham procedure. The control group received usual care. TT and sham procedure took 10-15 minutes.
PHASE OF CARE: Transition phase after active treatment
Three-group sham-controlled randomized clinical trial
Brief Pain Inventory
Only pain interference was reported. No information was provided on pain severity. After the first TT session, there were no significant differences between groups in pain interference results. After session 7, those in the TT group showed lower pain interference for activity (p = 0.001), mood (p = 0.001), walking ability (p = 0.001), relationships with other people (p = 0.001), and sleep (p = 0.001).
TT may be helpful for pain management in patients with cancer and managing sleep disturbance related to pain.
TT is a low-risk intervention that may be beneficial for some patients in managing pain and reducing the impact of pain on sleep. This study had multiple limitations. Further well-designed research in effectiveness of TT for varied types of pain is needed.
Scarpa, M., Pinto, E., Saraceni, E., Cavallin, F., Parotto, M., Alfieri, R., . . . QOLEC Group. (2017). Randomized clinical trial of psychological support and sleep adjuvant measures for postoperative sleep disturbance in patients undergoing oesophagectomy. British Journal of Surgery, 104, 1307–1314.
The purpose was to evaluate the effects of psychological counseling and sleep adjuvant measures on postoperative qualify of life and sleep in patients undergoing an esophagectomy.
Four groups were included: (a) psychological counseling plus sleep measures during the intensive care unit (ICU) stay, (b) psychological counseling alone, (c) sleep adjuvant measures alone during the ICU stay, or (d) standard care. Psychological interventions were performed by a psychologist in four or more sessions during the hospital stay according to a cognitive-interactive model. Sleep adjuvant measures included being in a quiet corner of the ICU provided earplugs and eye masks. Patients were instructed on the use of each but were free to use them as needed. Nurses concentrated their routine assessment when possible.
PHASE OF CARE: Active antitumor treatment
Randomized four-group trial
EORTC C30, PSQI
Psychological counseling reduced the decline in quality of life (odds ratio [OR] 0.23) and sleep quality (OR 0.27). The study was stopped early because of changes in the ICU setting.
Psychological counseling was beneficial in reducing the decline in quality of life and sleep impairment following esophagectomy. This is a labor-intense intervention, and consideration of the nursing factors in the sleep adjuvant measures is important.
Following esophagectomy, patients are at high risk of quality-of-life impairments and sleep problems. This study identified benefits to psychological counseling as well as adjuvant sleep measures. The sleep measures could be incorporated into clinical care for any surgical patient and show promise to impact sleep problems. Additional research is warranted.
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.
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
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
TOTAL REFERENCES RETRIEVED: 608 in initial search, 14 in final analyses
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Appropriate
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: Multiple phases of care
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.
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.
MBSR and MBCT show promise for symptom management in women with breast cancer, but more evidence is needed prior to widespread implementation.
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.
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
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
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.
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: Multiple phases of care
APPLICATIONS: Elder care, palliative care
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.
The benefits of MBIs on sleep problems in cancer survivors are uncertain because of the variability in these trials.
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.
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.
Yun, M.R., Song, M., Jung, K.H., Yu, B.J., & Lee, K.J. (2017). The effects of mind subtraction meditation on breast cancer survivors' psychological and spiritual well-being and sleep quality: A randomized controlled trial in South Korea. Cancer Nursing, 40, 377–385.
The purpose was to examine effects of mind subtraction meditation on depression and other aspects of well-being.
Patients were randomized to groups receiving meditation or an active control of self-management education. The meditation group participated in sessions twice weekly for two hours over eight weeks. The first four sessions included self-management education, and full meditation began during the fifth session. Group members were sent texts and emails to encourage home meditation twice per week. The education group had two-hour sessions weekly for four weeks, including information on relationships, communication, managing stress, and comfort. Study assessments were done at baseline and weeks 4 and 8.
RCT with active control
There were no differences between groups at week 4. At week 8, there were significant group differences in depression (p = 0.034), perceived stress (p = 0.009), anxiety (p = 0.036), as well as other measures. Before meditation, 90% of those in the meditation group reported sleep problems, and after the intervention, 9.1% reported problems. Evaluation of change in sleep quality showed more in the meditation group reported improvement and none reported worsening sleep quality over the eight-week study period (p = 0.010). Attendance in both groups ranged from 75% to 100% of the sessions.
Participation in meditation resulted in improved symptoms of depression and anxiety and improvement in sleep quality.
Meditation may be beneficial for patients to improve sleep and reduce symptoms of anxiety and depression. Additional evidence beyond this study is needed to evaluate these effects.