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.

• N = 227
• AGE: Mean 49.63 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Breast cancer stages 1-3
• OTHER KEY SAMPLE CHARACTERISTICS: Newly diagnosed before starting treatment

• SITE: Not stated or unknown   
• SETTING TYPE: Multiple settings    
• LOCATION: Large medical setting, MD Anderson Houston

PHASE OF CARE: Multiple phases of care

Randomized controlled trial

• Primary outcomes: Sleep was measured using self-reported Pittsburgh Sleep Quality Index (PSQI); fatigue was measured using the Brief Fatigue Inventory.
• Secondary outcomes included objective sleep using actigraphy.

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.

• Risk of bias (no blinding)
• Findings not generalizable
• Questionable protocol fidelity
• Other limitations/explanation: Large number of participants were lost to follow-up.

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.

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.

• N = 90   
• AGE: Mean 54.51 years
• MALES: 100%  
• KEY DISEASE CHARACTERISTICS: Disease type not stated
• OTHER KEY SAMPLE CHARACTERISTICS: All had chronic pain and had been treated for cancer for at least one year.

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

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.

• 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
• Measurement or methods not well described
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Timing of measurement not reported. No information about baseline pain, use of analgesics, etc., is provided. No information on diagnosis and type of pain. Provision of TT requires specific training.

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.

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.

• N = 74; 16, 19, 19, and 20 in each group   
• AGE: 61–67 years (average). Range was 51–75.
• MALES/FEMALES: Given in ratios 15:1, 17:2, 15:4, and 16:4  (male:female)  
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Patients undergoing esophagectomy for resectable esophageal cancer

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Site: ICU, Setting: Hospital, Location: Italy

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.

• Small sample (< 100)
• Other limitations/explanation: The study was stopped early. It is not known how closely patients followed the sleep adjuvant measures.

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.

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.

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.

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.

• N = 52; 48 assessed at week 8   
• AGE: Mean 48.44 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Mean time since surgery was 9 months; most had chemotherapy and endocrine therapy.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: South Korea

RCT with active control

• CES-D for depression
• Beck Anxiety Inventory
• FACT-Breast – quality of life
• Satisfaction With Life Scale
• Pittsburgh Sleep Quality Index – Korean version
• Posttraumatic Growth Index

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.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Other limitations/explanation: It is not stated whether sessions were done in a group setting, in which case, group interaction and support could have affected results. The education group received much less attention.

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.

The study goals were to (a) identify determinants of sleep disturbances in patients with breast cancer (BC) before radiotherapy, (b) determine the trajectory of sleep disturbances during radiotherapy and at 12-month follow-up, and (c) assess whether an exercise intervention could affect sleep trajectories.

The exercise intervention consisted of eight progressive resistance exercises (3 sets, 8–12 repetitions at 60%–80% of one repetition maximum). The relaxation control group did progressive muscle relaxation according to the Jacobson method. Both interventions were supervised and performed over approximately one hour twice weekly for 12 weeks along with other patients with cancer.

• N = 160 patients with BC; 25 controls (healthy women) 
• AGE: Patients with BC M = 55.6 (SD = 9.0); healthy women M = 53.1 (SD = 10.0)
• FEMALES: 100%
• CURRENT TREATMENT: Radiation, other
• KEY DISEASE CHARACTERISTICS: Stage 0-III primary BC after lumpectomy or mastectomy and scheduled for radiotherapy; 51% diagnosed in stage 1; 67.8 mean days since surgery 
• OTHER KEY SAMPLE CHARACTERISTICS: Average BMI = 26.9 kg/m²; 21.3% had BMI ≥ 30; majority reported little engagement in exercise before BC diagnosis.

• SITE: Single site    
• SETTING TYPE: Hospital outpatient clinic     
• LOCATION: Germany

PHASE OF CARE: Active antitumor treatment

Prospective randomized controlled intervention trial with attention control (relaxation) and healthy control

• Fatigue Assessment Questionnaire (FAQ), a self-report (in past week) of global sleep assessment using a single item indicating sleep disturbance with a 4-point Likert scale
• EORTC-QLQ-C30 insomnia subscale
• Sleep-related characteristics: sleep duration (hours per night), number of awakenings per night, daytime napping (minutes), frequency per week of sleep problems (> 30 minute sleep onset, trouble staying asleep, too early awakenings) using 5 categories (never, 1-2 days, 3-4 days, 5-6 days, all days)  
• Sleep measures were completed at 6 time-points: before intervention/radiotherapy (t0), after 6 weeks (t1), after 12 weeks (t2), and at 2, 6, and 12 months postintervention (t3, t4, t5).

Higher prevalence of sleep disturbances were observed among patients with BC who had previous chemotherapy, higher BMI and depressive symptoms, previous hysterectomy, degenerative diseases, thyroid disorders, and higher symptom burden (hot flashes, pain, breast or arm problems, dyspnea). Patients with BC experienced higher levels of sleep disturbance at all times, but the trajectory of sleep disturbances in exercising women was similar to healthy women. The exercise intervention significantly decreased sleep disturbances compared to the relaxation control group on a 0–100 scale (between-group mean differences of -10.2; p = 0.03) from baseline to the end of radiotherapy and -10.9 (p = 0.005) to the end of the intervention). Sleep disturbances decreased in the exercise group and increased in the control group. At 12 months, differences were observed but not statistically significant (mean difference = -5.9, p = 0.20) even after adjusting for potential confounders.

This exercise intervention trial supports the findings of smaller studies that radiotherapy worsens sleep disturbances in patients with BC compared to healthy women. Findings suggest that a 12-week resistance training during radiotherapy can have positive effects on sleep disturbances during the treatment phase and even months after treatment completion.

• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Measurement or methods not well described
• Measurement validity or reliability questionable
• Other limitations/explanation: Measurement or methods not well described in this secondary analysis of the “BEST” study (unable to determine sample demographics, blinding, and protocol fidelity in this publication or other referenced earlier publications)

Sleep quality is associated with quality of life in patients with cancer. These findings about determinants of sleep disturbance, the course sleep disturbance during radiotherapy, and the effect of an exercise intervention are of significance to many patients with BC.

The purpose was to determine the effects of a physical activity behavior change intervention compared to usual care on sleep quality in post-primary treatment breast cancer (BC) survivors.

Participants were randomized to a three-month, social cognitive theory-based Better Exercise Adherence after Treatment for Cancer (BEAT Cancer) behavior change intervention or usual care. BEAT Cancer included 12 supervised exercise sessions with exercise specialists during the first six weeks, followed by unsupervised home-based exercise supported by counseling sessions with exercise specialists every two weeks. Participants also completed 6 group discussion sessions with topics about exercise barriers and benefits, goal setting, behavioral modification, safety, relapse prevention, and exercise role models. The goal of BEAT Cancer was to complete ≥ 150 minutes of moderate-to-vigorous physical activity each week. Study measures were completed at three time points: baseline, immediately postintervention (month 3), and 3 months postintervention (month 6).

• N: 222 women with BC
• AGE: Patients with BC M = 55.6 (SD = 9.0); healthy women M = 53.1 (SD 10.0)
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: History of ductal carcinoma in situ (DCIS) or stage I-IIIA BC, ≥ 8 weeks postsurgery and postprimary treatment (could be on longer-term treatments such as antiestrogen therapy) 
• OTHER KEY SAMPLE CHARACTERISTICS: Reported average of ≤ 30 minutes of vigorous physical activity or ≤ 60 minutes of moderate activity per week during the past six months

• SITE: Multisite   
• SETTING TYPE: 3 academic institutions    
• LOCATION: United States

PHASE OF CARE: Transition (postprimary treatment, could be on hormonal therapy)

Randomized controlled intervention trial with usual care control

• Pittsburgh Sleep Quality Index (PSQI)
• MTI/Actigraph accelerometer models GT1M and GT3X (7 nights)

The BEAT Cancer intervention significantly improved PSQI global sleep quality when compared with usual care at postintervention (mean between-group difference [M] = -1.4; 95% CI = -2.1 to -0.7; p < 0.001) and 3 months postintervention (M = -1.0; 95% CI = -1.7 to -0.2; P = .01), after adjusting for covariates. BEAT Cancer improved several PSQI subscales at postintervention (sleep quality M = -0.3; 95% CI = -0.4 to -0.1; p = 0.002; sleep disturbances M = -0.2; 95% CI = -0.3 to -0.03; p = 0.016; daytime dysfunction M = -0.2; 95% CI = -0.4 to -0.02; p = 0.027) but not 3 months postintervention. A nonsignificant increase in the percentage of participants classified as good sleepers was reported. No significant between-group difference was noted for accelerometer sleep latency or efficiency.

A social cognitive theory-based physical activity intervention reduced perceived global sleep disturbance at postintervention and 3 months postintervention compared to usual care, primarily related to improvements in various aspects of sleep quality. However, improvements were not detected with accelerometer.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement and methods not well described
• Measurement validity and reliability questionable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: No blinding, no attentional control group, lack of sample diversity, potential risk of intervention diffusion between groups, no reported participant withdrawals or protocol fidelity data 

Exercise adherence intervention may reduce perceived global sleep disturbance at 3 and 6 months postintervention. Additional exercise research in oncology is needed to optimize the use of physical activity in improving the health and well-being of cancer survivors through improved sleep.

STUDY PURPOSE: To determine the effects of nonpharmacologic interventions on sleep quality in patients with lung cancer

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, WHO International Clinical Trials Registry Platform Search Portal and Clinical Trials.gov

YEARS INCLUDED: Open start date through December 2016

INCLUSION CRITERIA: Nonpharmacologic intervention studies of any design for patients with lung cancer at any stage or illness and at any point in treatment, compromising at least 25% of participants who used sleep disturbance or quality as primary or secondary outcome by subjective or objective measure

EXCLUSION CRITERIA: None noted

TOTAL REFERENCES RETRIEVED: N = 1,259 

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two authors reviewed all studies for eligibility, and disagreements were resolved through discussion and third author as needed.

FINAL NUMBER STUDIES INCLUDED: N = 22

TOTAL PATIENTS INCLUDED IN REVIEW: 1,272

SAMPLE RANGE ACROSS STUDIES: ≤ 10 = 3 studies, > 10 < 100 = 16 studies , ≥ 100 = 3 studies 

KEY SAMPLE CHARACTERISTICS: 82.4% of participants had lung cancer, > 66% had stage III or IV illness and were undergoing treatment.

PHASE OF CARE: Multiple phases of care

Interventions were grouped into 3 categories. Standard exercise and rehabilitation programs showed statistically significant improvements in sleep outcome measures in the short-term follow-up period (SMD -0.43, 95% CI; -0.68, -0.19, p = 0.0005). No differences were seen at the medium- and longer-term follow-up periods. Information, psychoeducation, and symptom screening interventions showed significant differences when compared to control at short-term follow up but was not measured at a later interval (SMD: -0.87, 95% CI, -1.21, -0.54, p, 0.00001). Mind-body interventions (2 studies with n < 100) showed large effect in treating sleep disturbances in patients with lung cancer in the short-term follow-up period (SMD: -0.88, 95% CI, -1.59, -0.16, p = 0.02), which were not observed at the medium follow-up period.

Although the three groups of interventions, exercise, information, psychoeducation, and mind-body interventions appear to improve sleep disturbances in the short term following the interventions, the data quality is low. The series of 22 studies looks at multiple interventions per category, some with small sample sizes, and uses a variety of delivery methods. Based on individual assessments and results of studies in other cancer populations, nurses may want to recommend the interventions to patients with lung cancer, at least to try. However, the call for ongoing research in the area continues, with specific focus on larger sample sizes, specific disease states, and single interventions.

• Mostly low quality/high risk of bias studies
• High heterogeneity
• Low sample sizes

The data for recommending use of nonpharmacologic interventions for sleep disturbances in patients with lung cancer are not sufficient. It is clear that they are feasible and may be effective in some instances. It does appear that they may improve sleep disturbance in the short term, but further work is needed to conduct larger studies and examine individual interventions and their components, as well as the treatment phase for the patient in which the intervention in applied. Based on assessment of patient condition and desire, nurses can use their judgment to make recommendations for patients with lung cancer to try nonpharmacologic interventions to improve sleep.

The purpose was to study the effects of cognitive behavioral therapy on quality of life (QOL) among patients post-cancer treatment through a reduction in insomnia.

Four participant groups were created: those receiving CBT-I + placebo, CBT-I + armodafinil, armodafinil, and a placebo. CBT-I interventions took place over 7 weeks, where participants met one-on-one with a trained therapist and followed a treatment manual. Sessions were conducted once a week, with the first, second, and fourth held in person, and lasted 30-60 minutes; the third, fifth, sixth, and seventh were held over the telephone over 15-30 minutes. For groups taking armodafinil, 50 mg was taken in the morning and afternoon for 47 days. QOL was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) instrument, while insomnia severity was measured with the Insomnia Severity Index (ISI). These surveys were completed by participants before receiving the intervention, during the intervention, postintervention, and 3 months following the intervention completion.

• N: 95   
• AGE: Range = 26-75 years, Mean = 56.2 years
• MALES: 11.6%  
• FEMALES: 88.4%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Cancer survivors of any type who had completed chemotherapy and/or radiation therapy at least one month or longer prior to the study start, with an inclusion criteria of baseline clinically diagnosed chronic insomnia.

• SITE: Multisite   
• SETTING TYPE: Multiple settings    
• LOCATION: Two northeastern U.S. cities

PHASE OF CARE: Late effects and survivorship

Four groups were established in an RCT. Participants were blinded to medication but not CBT-I. Control groups received a placebo.

QOL was measured using the Functional Assessment of Cancer Therapy General (FACT-G), an instrument measuring physical, functional, social, and emotional well-being and scored from 0-108, with higher scores indicating better QOL. Insomnia severity was measured using the Insomnia Severity Index, ranging from 0-28, with higher scores indicating worse insomnia.

Both CBT-I groups reported improvement of significance in QOL scores with mean increase of 9.5 on the FACT-G scale (p < 0.0001) compared to the groups without CBT-I. There was no statistical difference in QOL reports between the CBT-I + placebo and CBT-I + armodafinil groups. However, correlational and path analysis indicated that these improvements on QOL were associated with improvements in insomnia and that CBT-I did not demonstrate a direct effect of significance on QOL scores but rather, a significant effect on insomnia severity (p < 0.0001) that demonstrated a significant improvement in QOL scores (p < 0.0001) From baseline, changes in QOL from pre- to postintervention for CBT-I+ placebo, CBT-I + armodafinil, armodafinil, and placebo were 9.6, 11.6, -0.2, and 3.3. Follow-up QOL for CBT-I + placebo, CBT-I + armodafinil, armodafinil, and placebo was 91.4, 93.8, 78.7, and 78.6, respectively, which did not demonstrate significance from postintervention.

CBT-I demonstrated a significant effect in the reduction of insomnia among cancer survivors, which resulted in an indirect improvement in patient QOL. However, generalizability and broad feasibility may be limited because of cultural and socioeconomic variances, as well as resource availability.

• Small sample (< 100)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%

Patient sleep quality and associated effect on QOL are important considerations for nursing. Regardless of intervention, this study demonstrates meaningful improvement of QOL can occur when sleep quality is improved. Nurses are in a relevant position to assess and advocate for interventions for sleep disturbance.