Cognitive Behavioral Interventions/Approach

STUDY PURPOSE: To review the efficacy of cognitive behavioral therapy (CBT) on sleep and psychological outcomes in patients with cancer and cancer survivors

• FINAL NUMBER STUDIES INCLUDED = 12
• SAMPLE RANGE ACROSS STUDIES = 10–260
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,153
• KEY SAMPLE CHARACTERISTICS: Most studies in breast cancer, but a few in mixed diseases

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care

Four of four uncontrolled trials showed a positive significant effect of CBT on sleep problems. Of eight RCTs, five showed a positive significant effect and three showed no difference between groups. One of these compared CBT to mindfulness-based stress reduction rather than usual care. One study showed no long-term effectiveness. Review of the evidence shows overall efficacy of CBT in patients without cancer. The intervention has been delivered effectively in person, individually or in groups, telephonically, and via the internet or videos.

The majority of evidence shows that CBT has a positive effect on sleep-wake disturbance in patients with cancer. The most effective duration, timing, and “dose” is unclear, but this approach appears to be effective when delivered with varied methods.

• This review does not provide a full report of search results or any method of quality evaluation of the studies included.  
• Reports individual study findings, but does not really synthesize and draw conclusions across studies

Evidence supports the effectiveness of CBT for sleep problems in patients with cancer, and this approach appears to be provided effectively in very practical ways, such as through videos and websites. At present, as reported in this review, CBT is seen as the treatment of choice for insomnia in patients with cancer. Future research for comparative effectiveness of various interventions for sleep disturbances is needed.

PHASE OF CARE: Multiple phases of care

CBT-I resulted in a significant improvement on sleep efficiency relative to control from pre- to postintervention (p < 0.01), with a medium effect size pooled across studies (0.53, 95% CI [0.39; 0.68]); and improvement at six-month follow-up (p < 0.01), with effect size (0.33,  95% CI [0.11, 0.54]). There were significant improvement on sleep onset latency relative to control from pre- to postintervention (p < 0.01), with a small to medium effect size pooled across studies (0.43, 95% CI [0.27, 0.58]); and it persisted at six months (p < 0.01), with effect size pooled across studies (0.27, 95% CI [0.11, 0.44]). And, finally, there were significant improvements on wake after sleep onset from pre- to post-intervention (p < 0.01), with a small to medium effect size pooled across studies (0.41, 95% CI [0.24, 0.59]) persisting at six months (p < 0.01), with effect size pooled across studies (0.27, 95% CI [0.11, 0.44]). Overall, there were statistically significant improvements in insomnia severity following CBT-I relative to control from pre- to postintervention (p < 0.01), with a large effect size pooled across studies (0.77, 95% CI [0.6, 0.93]). Four RCTs reported data on insomnia severity at six months (p < 0.01), with effect size pooled across studies (0.54, 95% CI [0.37, 0.73]).

The results of the meta-analysis indicate that survivors of cancer treated with CBT-I showed improvements in sleep efficiency, sleep onset latency, and wake after sleep onset as measured by sleep diaries, and insomnia symptom severity as measured by the ISI when compared to the usual care, waitlist control, or active comparator conditions. In addition, the observed effects persisted at six-month follow-up, suggesting that CBT-I provides significant, lasting improvements in sleep. Future research should examine the mechanisms by which CBT-I improves sleep in the cancer population. And specifically, the relative impact of behavioral versus cognitive change is unclear.

It was not possible to directly compare the efficacy of CBT-I as delivered either individually, in a group, online, or via video. Majority of included trials were conducted in women with stage I-III breast cancer, and it is unclear how well the observed results will generalize across the cancer continuum.

Individuals diagnosed with cancer are particularly vulnerable to insomnia with a prevalence rate almost twice that of the general population (50%–60% versus 12%–25%). CBT-I was effective across diverse treatment modalities, intervention lengths, and cancer diagnoses or stages in improving sleep diary outcomes that were durable at six months.

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

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

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

Studies were included in the review if they

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

Studies were excluded if they

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

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

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

Relaxation

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

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

Imagery and Hypnosis

Six studies examined imagery and hypnosis.

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

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

Twenty-one studies tested CBT/CST.

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

Meditation

Four studies were included.

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

Music

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

Findings of this review were equivocal.

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

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

To synthesize findings from intervention studies for sleep disturbance in patients with cancer and their caregivers.

Databases searched were PubMed, CINAHL, and PsycINFO.

Search keywords were sleep, sleep disturbance, insomnia, intervention, cancer, oncology, and caregivers.

Studies dated through 2010 that evaluated sleep disturbance/sleep quality as the primary or secondary outcome were included.

• The total number of references retrieved was not stated.
• The method of study evaluation was described for the type of intervention, mode of delivery, dose, and duration but not for study quality.
• There were only two studies that affected caregivers.

• The final number of studies included was 49 (47 targeting patients and 2 targeting caregivers). 
• Thirteen studies were included in the meta-analysis (total of 1,202 patients with cancer). 
• The total sample across all studies was 3,205 patients.
• The sample range across studies was 9 to 276 patients (including patients with cancer).
• Patients had various cancer types, phases of treatment, and stages of disease. 
• Women with breast cancer were studied most commonly.

Intervention groupings analyzed via meta-analysis included cognitive-behavioral therapy (CBT), education, exercise, and complementary and alternative therapies. Effect sizes appeared to be slightly over 1.0 for CBT, close to 0 for education, slightly over 1.0 for exercise, and slightly over 0 for complementary and alternative therapies. Specific effect sizes were only shown graphically, and actual data were not presented. No separate analysis of caregiver effects could be determined. Modes of delivery of interventions varied widely across studies.

Findings suggest at least moderate effects of CBT and exercise for improvement in sleep disturbances for patients with cancer. No substantial effects of exercise and education were demonstrated.

The review was limited by the lack of any data regarding heterogeneity in the meta-analysis, variability of interventions, and modes of delivery to enable any firm conclusions.

Insufficient evidence was provided to draw any conclusions regarding intervention effects for caregivers.

STUDY PURPOSE: To evaluate the effects of nonpharmacologic interventions on patient-reported sleep, pain, and well-being in people with cancer and other conditions

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 11
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,066
• SAMPLE RANGE ACROSS STUDIES: 28–276
• KEY SAMPLE CHARACTERISTICS: Included cancer, arthritis, fibromyalgia, musculoskeletal pain, and headache as painful conditions; six studies were of patients with cancer

PHASE OF CARE: Not specified or not applicable

All treatments had at least one component of cognitive behavioral therapy for insomnia. Subgroup analysis showed that the interventions tested were significant for both cancer and noncancer cases. Another subgroup analysis showed that effectiveness was significant for face-to-face interventions but not for those conducted via the phone or Internet. Analysis showed effects for sleep (standard mean difference [SMD] = 0.78, p < 0.0001 with high heterogeneity), pain (SMD = 0.18, p = 0.05), and fatigue (SMD = 0.38, p = 0.01).

Nonpharmacologic interventions involving components of cognitive behavioral therapy for insomnia were shown to be effective in improving sleep, pain, and fatigue among patients with and without cancer.

High heterogeneity

Interventions like cognitive behavioral for insomnia are beneficial to improve sleep, reduce fatigue, and positively affect pain.

To review the literature on nonpharmacologic supportive strategies to enhance quality of life (QOL) among patients with breast cancer experiencing cancer-related fatigue.

Databases searched were MEDLINE and CINAHL (2000–2010).

Search keywords were breast cancer patient, oncology patient, fatigue, cancer-related fatigue, quality of life, health-related quality of life, physical activity, and exercise.

Studies were included in the review if they 

• Were randomized, controlled trials or quasiexperimental designs
• Investigated nonpharmacological supportive strategies
• Had cancer-related fatigue and/or QOL as an outcome measure.

Eighty-nine articles were identified, of which 28 met the inclusion criteria. No method of quality rating of the studies was described.

• Twenty-eight studies including 2,164 patients were included.
• Sample sizes among studies ranged from 11 to 377 patients.
• All studies were performed in patients with breast cancer at various phases of care and receiving various types of treatment or after treatment.

Supervised exercise was used in eight studies.  Four of these showed that exercise significantly improved QOL and reduced fatigue.  Two studies showed that supervised exercise improved QOL but not fatigue; they had noted study limitations and intervention contamination. One large multi-site study showed that supervised aerobic exercise improved self-esteem, fitness, etc., but had no significant effect on QOL, depression, anxiety, or fatigue

Home-based exercise was used in six studies.  All of these confirmed a positive effect of participation in exercise on fatigue.  Fatigue levels either decreased, or those who exercised had significantly less increase in fatigue over time.

Telephone-based encouragement in activity was used in one study (25 patients).  At 12 weeks, there were significant increases in activity, QOL, and fatigue.

One study used print materials and step pedometers along with physical activity recommendations.  Those who received all three of these strategies had improved QOL and fatigue.

Education and counseling was used in five studies. Mixed results were seen across studies, with a positive effect on fatigue that was significant in three of these studies. 

Sleep therapy was examined in three studies.  Two of these demonstrated a significant positive effect on fatigue with cognitive behavioral therapy and insomnia treatment.  One large study using cognitive behavioral therapy showed improvement in sleep quality but no effect on fatigue.

Other interventions were yoga in one study, tai chi in one study, and physical therapy in one study.  Yoga was associated with an improvement in fatigue, and physical therapy was also associated with improvement, although this was only studied in 11 patients.

This review generally showed that supervised exercise and supervised exercise and other strategies to promote exercise can reduce cancer-related fatigue and improve QOL in women with breast cancer.  Findings were limited by several studies with small sample sizes and variations in the phases of care in which the interventions were provided. There was insufficient evidence to draw conclusions about the complementary therapies included.

• Studies of supervised education demonstrated mixed results.
• Several studies had small samples or other limitations.
• Application should be used cautiously.

Based on current evidence, exercise, educational counseling, and sleep therapy appear to be helpful methods to improve QOL and reduce fatigue. Because of methodological limitations of many of these previous studies, further well-designed research is needed to confirm these conclusions.

To test the feasibility of providing a psychoeducational intervention for people with head and neck cancer.

The NuCare coping strategies program used a self-study book and audiocassette designed to enhance personal control and teach emotional and instrumental coping responses. It consisted of training in problem solving, relaxation, coping skills, goal setting, communication, social support, and lifestyle factors. Three participants chose to receive it in a small group format, 33 chose one-on-one sessions with a therapist, and 23 chose a home format with no therapist. The outcomes measured were quality of life (QOL), anxiety, and depression.

• The study was comprised of 66 patients with head and neck cancer; 59 completed the program and 50 gave outcome data.
• No age, gender, race, or ethnicity demographics were provided.

The study was conducted at the head and neck oncology outpatient clinic of the Montreal Jewish General Hospital, Quebec, Canada.

Patients were undergoing the active treatment phase of care and were evaluated at baseline and three-month follow-up.

This was a prospective, nonrandomized, one-group, feasibility study.

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLC-C30) was used to measure QOL and sleep.

Patients reported improvement in physical and social functioning and global QOL, sleep disturbance, fatigue, and depressive symptoms.

• Patients were able to choose which format was used.
• The pilot study was not designed to test the effectiveness of the intervention.
• Special training of the research nurse was required.
• There was no cost to patients.

To compare if individual psychosocial support for patients with breast cancer provided by oncology nurses specially trained in cognitive behavioral techniques was as effective as that given by psychologists or standard care.

Patients received individualized psychosocial support interventions using cognitive behavioral techniques, such as relaxation, distraction, activity scheduling, and ways to improve communication. The frequency of sessions varied based on patients' perceptions of need. Patients were randomized in blocks of nine into one of three alternatives:  60 received individual psychosocial support by a specially trained oncology nurse, 60 received it from a psychologist, and 59 received standard care. Outcomes measured were quality of life (QOL), fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.

• The study was comprised of 179 consecutive patients with breast cancer about to start adjuvant treatment.
• Mean age was 55 years (range 23–87).

The study was conducted at the Department of Oncology, Uppsala University, Sweden.

Patients were undergoing the active treatment phase of care.

This was a prospective, randomized, quasiexperimental study using repeated measures at baseline and at one, three, and six months.

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLC-C30)
• EORTC QLQ–Breast Cancer (EORTC QLQ-BR23)
• Hospital Anxiety and Depression Scale (HADS)
• Impact of Event Scale (IES)
• State Trait Anxiety Inventory–State (STAI-S)

The results revealed statistically significant group by time interactions for global QOL and health status, nausea and vomiting, and systemic therapy side effects. Intervention groups showed statistical differences on the insomnia, dyspnea, and financial difficulties EORTC subscales, in favor of one or both of the interventions.

• The number of sessions varied and was determined by the need and desire of individual patients.
• There was a need for special training to deliver the intervention.

To evaluate the efficacy of an energy and sleep enhancement (EASE) intervention to relieve fatigue and sleep disturbance and improve health-related functional status.    

One hundred fifty-three individuals receiving chemotherapy were randomized to the EASE intervention and 139 were randomized to an attention control intervention. Participants in each group received three telephone sessions taught by a specially trained oncology nurse and a separate written handbook for each assigned intervention. The EASE intervention was based on the common sense model and involved appraisal and representation of symptoms, with a focus on fatigue and sleep disturbance, including communication of individualized strategies for fatigue management and sleep enhancement. The control intervention focused on information about nutrition and a healthy diet. The primary outcomes of fatigue, sleep disturbance, and functional status were measured before chemotherapy, day 4 after first treatment (baseline), and 43 to 46 or 57 to 60 days later (follow-up), depending on the chemotherapy cycle length. Two secondary outcomes, pain and depression, were chosen for evaluation, but not targeted for the intervention, because of an increasing body of evidence linking them to fatigue.

• Two hundred seventy-six patients (83% female and 17% male) receiving chemotherapy were included.
• Mean age was 53.9 years (SD = 12.02).
• The most common cancer diagnoses were breast (55%), lung (17%), lymphoma (8%), and ovarian (6%).
• Of the patients, 90% were Caucasian, 70% were married, 42% were college educated, and 95% were treated with chemotherapy alone.

• Multi-site study conducted at two universities:  one community cancer center and one comprehensive cancer center
• Outpatient
• The intervention was delivered by nurses at Fox Chase Cancer Center, Philadephia, PA
   

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial using repeated measures and an attention control.

• Demographic and clinical information form    
• General Fatigue Scale (GFS)
• Profile of Mood States Fatigue subscale (POMS-F)
• Pittsburgh Sleep Quality Index (PSQI)
• Octagonal Basic Motionlogger Actigraph
• Morin Sleep Diary
• Brief Pain Inventory (BPI)
• POMS Depressive symptoms subscale (POMS-D)
• Symptom Checklist (SCL)
• Adapted BPI interference items (SXINT)
• Short Form 12 Health Survey (SF-12)
• Eastern Cooperative Oncology Group (ECOG) Performance Status
   

Fatigue and patient-reported sleep disturbance were moderately elevated in both groups at baseline and follow-up. Actigraphy revealed that the total sleep time was almost eight hours, and sleep efficacy was in the normal range of greater than 85% for both groups at both time points. Physical functioning was diminished and at the same level as a sample with serious illness. Mental functioning was in the normal range. The EASE intervention did not improve fatigue, reduce sleep disturbance, or prevent functional decline during chemotherapy. Both the EASE intervention group and the control group had an increase in fatigue and decline in physical functioning over time. ANOVA revealed no statistically significant group-by-time effects for fatigue, sleep disturbance, or functional status. A positive outcome in both groups was a decrease in the average number of nighttime awakenings over time. Unemployed individuals showed greater benefit from the EASE intervention and reported less pain and symptom interference.

In patients with cancer undergoing chemotherapy, the EASE intervention did not significantly improve fatigue, sleep disturbance, or physical functioning compared to the control group. Potential explanations include high variability or floor effect for fatigue, incorrect timing of measures, insufficient amount or dose of the intervention, and confounding effects of gender. Future research should consider screening for symptom severity and tailoring interventions.

• The ineffectiveness of EASE could be affected by the intervention dose, timing of the measures, and the large number of participants with low symptom severity.
• There was an overrepresentation of patients with breast cancer and underrepresentation of patients with lung cancer.
• Factors that may have affected the outcome included variation in populations, treatments being received, and lack of control over the severity of symptoms.

Future research directions were clearly described in the study, and practice implications included:  many individuals with multiple symptoms during chemotherapy could benefit from effective behavioral interventions conducted over time by skilled nurses. Further research could inform nurses of the most effective management methods to control symptoms.

To determine the effect of behavioral therapy (BT)—specifically, an individualized sleep promotion plan (ISPP)—on sleep quality and fatigue in patients with breast cancer undergoing adjuvant chemotherapy.

Eligible women who consented to participate were randomized using stratified random sampling to either the BT group or to a healthy eating control (HEC) group prior to adjuvant chemotherapy. Patients completed questionnaires at baseline and wore a wrist actigraph for two days prior to initial treatment. Patients randomized to the BT group developed an ISPP during individual visits with the research nurse two days prior to treatment. Modifications to this plan were made two days prior to each treatment and 30 days after the last treatment. Modifications were based on patients' sleep diary data and treatment adherence. BT plans were reinforced during 15-minute sessions seven days after each revision. Patients in the HEC group received equal time and attention during individual visits and received information on healthy eating topics at each visit. Patients in the HEC group were referred to their treatment clinic for questions about fatigue and sleep.

• The study was comprised of 219 female patients with breast cancer.
• Mean age was 52.13 years (range 29–79) in the BT group and 52.16 years (range 30–83) in the HEC group.
• Patients had an initial diagnosis of stage I to IIIA breast cancer and had undergone either modified radical mastectomy or lumpectomy.
• Of the patients, 70% were partnered and 74% had at least some college education.
   

The study was conducted in 12 oncology clinics in the Midwestern United States.
 

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial.

• Symptom Experience Scale (SES):  This scale measures frequency, intensity, and distress associated with six symptoms associated with cancer treatment. Scores for fatigue and sleep were not included in the mean SES score because they were measured in-depth by other study instruments.    
• Hospital Anxiety and Depression Scale (HADS): This scale measures anxiety and depression symptoms.
• Medical Outcomes Study Short-form General Health Survey (MOS-SF 36-v2):  The physical functioning subscale of this measure was used to measure physical functioning prior to cancer diagnosis.
• Piper Fatigue Scale (PFS):  The PFS is a 22-item scale of subjective cancer-related fatigue. The PFS was used at each treatment because fatigue was expected to fluctuate from treatment to treatment. Higher scores on the PFS indicate worse fatigue. Reported internal consistency for this study was 0.93 to 0.98.
• Pittsburgh Sleep Quality Index (PSQI):  The PSQI is a 19-item subjective measure of sleep quality over the past month. Seven component scores are summed to obtain global scores ranging from 0 to 21, with higher scores indicating greater sleep difficulties. In women with breast cancer, Cronbach’s alpha for global PSQI score is 0.80; it was 0.74 to 0.83 for this study.
• Wrist actigraphy and daily diaries were used to measure sleep variables. The study used the Motionlogger® Actigraph with one-minute epochs. Variables included total sleep time after sleep onset, sleep efficiency, number of awakenings, and minutes and percent awake after sleep onset. Actigraphs were recorded 48 hours before the initial treatment, for seven days and nights during treatment and for seven days and nights 30 days after the last treatment.
  
  
  
  
   

Mean PSQI scores in both groups were greater than five, which indicated poor sleep compared to the general population; however, mean scores were not greater than eight, a cutoff score associated with poor sleep quality in patients with breast cancer. Actigraphy and diary data showed normal sleep duration and sleep efficiency in both groups across treatment and follow-up. Number of awakenings after sleep onset measured by both sleep diaries and actigraphy were higher than normal in both groups. Significant differences between sleep diaries and actigraphy were observed for all sleep variables (p < 0.01 for all variables), with lower numbers of awakenings and higher sleep efficiency per diary data in the BT group. A significant group by time interaction was found for changes in the PSQI, with sleep quality improving in the BT group (p < 0.049). Although not significant, there were trends towards improved sleep quality over time in the BT group per actigraphy for total sleep time and number of awakening and per sleep diary for sleep efficiency. Perceived fatigue changed significantly over time in both groups (p < 0.001), with increased fatigue during treatments and decreased fatigue after the end of treatments in both groups. There was no apparent effect of BT on fatigue levels.

Patients in the BT group showed greater improvement in sleep quality over time than those in the the HEC group, although perceptions of improved sleep quality were not consistently associated with objective sleep measures, sleep diaries, or reported fatigue. BT was not shown to have an effect on fatigue.

• There was a lack of true baseline values of sleep and fatigue because patients were enrolled after surgery.
• There was no control of patients’ expectations of treatment.
• There were modifications to stimulus control and restriction therapy within the BT intervention model.
• The study population lacked racial/ethnic diversity.

BT may be used by trained nurses to improve sleep quality in patients with breast cancer receiving adjuvant chemotherapy. Further research is needed to determine the long-term effects of BT on sleep quality and fatigue in this population.

To evaluate the outcomes of an intervention designed to promote sleep and modify fatigue after adjuvant breast cancer chemotherapy.

A multicomponent cognitive-behavioral therapy in the form of a four-part intervention consisting of sleep hygiene counseling, relaxation therapy, sleep restriction, and an individualized sleep promotion plan (ISPP) stimulus control was used. It started two days before the first chemotherapy treatment; continued during treatment; was revised 30, 60, and 90 days after the last treatment; and was reinforced seven days later. Sleep and fatigue were the outcomes measured.

• The study was comprised of 21 female Caucasian patients with stage I or II breast cancer following adjuvant chemotherapy.
• Mean patient age was 55.3 years (range 43–66).

The study was conducted in the Midwestern United States in the patients’ homes.

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

This was a prospective, repeated measures, quasiexperimental feasibility study.

• Pittsburgh Sleep Quality Index (PSQI)
• Daily diary
• Wrist actigraph

High adherence to the four components of the ISPP was found, except for stimulus control. Sleep latency remained stable. Sleep efficiency ranged from 82% to 92%, and total rest ranged from seven to eight hours per night. The number of night awakenings ranged from 10 to 11 per night.

• The pilot study was not designed to test the effectiveness of the intervention.
• Research RN training was required.
• Actigraphs incurred a cost.

A multicomponent cognitive-behavioral therapy in the form of a four-part intervention consisting of sleep hygiene counseling, relaxation therapy, sleep restriction, and an individualized sleep promotion plan (ISPP) stimulus control was used. It began two days before the first chemotherapy treatment, was revised before each treatment, and was reinforced seven days after each treatment. Restrictions were delivered by RNs. Sleep and fatigue were the outcomes measured.

• The study was comprised of 25 female Caucasian patients with stage I or II breast cancer during adjuvant chemotherapy.
• Mean patient age was 54.3 years (range 40–65).

The study was conducted in the Midwestern United States, in urban oncology clinics and the patients’ homes.

Patients were undergoing the active treatment phase of care.

This was a prospective, repeated measures, quasiexperimental, feasibility study.

• Pittsburgh Sleep Quality Index (PSQI)
• Daily diary
• Wrist actigraph

Sleep latency, sleep efficiency, total rest, and ratings of feeling refreshed on awakening were stable. Time awake after sleep onset and nighttime awakenings exceeded desired levels.

• The pilot study was not designed to test the effectiveness of the intervention.
• Research RN training was required.
• Actigraphs incurred a cost.

To pilot test the acceptability of a DVD platform to deliver a newly created cognitive-behavioral hot flash intervention and estimate its efficacy.

Participants viewed a DVD consisting of video clips demonstrating the intervention, which included one cognitive activity (distraction) and two behaviors (remain still, breathe). The video clips demonstrated the intervention during three situations:  resting at home, during housework, and in a work environment. Participants were asked to practice the intervention for one week. Outcomes measured were hot flash occurrence, severity, bother, mood disturbance, affect, hot flash disruption, and sleep disturbances.

• The sample was comprised of 49 women (26 at site 1 and 23 at site 2), with 40 completing all aspects of the study.
• Women with any stage of breast cancer or at high risk for disease were included.
• Mean age was 54.42 years, and all women were 21 years or older and experiencing hot flashes (93% were postmenopausal).
• Of the women, 75% were Caucasian.

The study was conducted at outpatient cancer clinics serving rural and urban areas in the midwestern and southeastern United States.

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

This was a nonrandomized, pre/post-test pilot study design.

• Center for Epidemiologic Studies Depression Scale (CESD)
• Profile of Mood States–Short Form (POMS-SF)
• Positive and Negative Affect Schedule (PANAS)
• Biolog®3991
• Hot flash severity and bother numeric rating scales
• Hot Flash-Related Daily Interference Scale (HFRDIS)
• Pittsburgh Sleep Quality Index (PSQI)
• Actiwatch®

The DVD was an accepted and feasible intervention delivery method. Although statistically significant improvement in hot flash parameters was observed, changes were equal to about a 10% change. The 10% reduction in hot flashes affected related outcomes, with the HFRDIS improving in all participants and CESD scores improving in the subset that reported the worst hot flash severity. No change in affect or sleep was noted.

• The unblinded, single-group design allows for placebo effect.
• The study had a small sample size.
• There was difficulty quantifying the frequency of intervention use; therefore, the variable was not included in the analyses.
• Drawbacks to using a DVD include the one-way nature of instruction and limited opportunity for participants to ask questions.

To examine the efficacy of an early minimal cognitive behavioral therapy (CBT) intervention for insomnia in patients with cancer

The treatment consisted of self-help CBT provided with written materials and three phone consultations. Participants completed a quiz after each booklet was read and were asked to maintain a daily sleep diary. Control patients did not receive any intervention. The study was conducted over six weeks. Study measures were obtained at baseline, at the end of six weeks, and three and six months later. Participants were paid after each assessment was completed.

• N = 35  
• MEAN AGE = 56.9 years (SD = 10 years)
• MALES: 7.9%, FEMALES: 92.1%
• KEY DISEASE CHARACTERISTICS: Most had breast cancer; various other types included
• OTHER KEY SAMPLE CHARACTERISTICS: 60% were married, 65.8% were in current treatment for cancer with radiation therapy and/or chemotherapy

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

• PHASE OF CARE: Multiple phases of care

Randomized, controlled trial

• Insomnia Interview Schedule (IIS)
• Insomnia Severity Index (ISI)
• Sleep diary
• Hospital Anxiety and Depression Scale (HADS)
• Multidimensional Fatigue Inventory (MFI)
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
• Dysfunctional Beliefs and Attitudes About Sleep–Short Form (DBAS-SF)
• Sleep Behaviors Questionnaire (SBQ)

There were significant effects over time by study group on ISI scores in favor of the CBT intervention at six weeks (p < 0.001), and there were improvements in all sleep variables with effect sizes (d) ranging from 0.46–1.34. Control patients also showed improvements. There were no significant changes from the six-week to six-month time point in either group. Those in the CBT group had a reduction in hypnotic dosage (d = 0.40). There were significant improvements in anxiety scores (p < 0.001) in the CBT group at six weeks. Depression declined significantly in both groups. No significant effect on fatigue was found. A greater proportion of CBT patients achieved a sleep efficiency level greater than or equal to 85% (p = 0.01). More than 97% of patients completed the materials, and 91.2% completed the quiz on average.

The brief CBT intervention used here was effective in improving insomnia and anxiety among patients with cancer.

• 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: Use of hypnotics was not described after baseline

CBT interventions are effective in treating sleep–wake disturbances and psychological issues. This study demonstrated that the provision of a CBT approach via booklets and quizzes on the CBT for sleep content with follow-up and counseling by phone was an effective way to deliver the intervention. Although this sample size was small, it did approximate the size required from a power analysis. This approach to providing a CBT intervention can be practical and cost-effective. However, significant effects were only seen during the active study period, and effects were not shown to endure long-term.

To compare the effectiveness of a cognitive-behavioral therapy (CBT) group intervention versus a relaxation and guided imagery (RGI) group training intervention.

The intervention groups received nine 90-minute weekly sessions, and the control group received standard care. The outcomes measured were psychological distress, sleep, fatigue, and health locus of control.

• The study was comprised of 170 patients with stage I or II breast cancer.
• Patients were between two and 12 months since surgery and were receiving treatment (chemotherapy or radiotherapy).

Oncology center in northern Israel

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial.

• Brief Symptom Inventory (BSI)
• Fatigue Symptom Inventory (FSI)
• Perceived Stress Scale-10-item (PSS-10)
• Mini Sleep Questionnaire (MSQ)
• Multidimensional Health Locus of Control (MHLC)
• Global Severity Index (GSI)
• Adherence questionnaire with a Likert scale
   

GSI and perceived stress decreased in both intervention groups but not in the control group. Means of fatigue symptoms and sleep difficulties decreased in both intervention groups but only significantly in the RGI group. External health locus of control decreased more in the CBT group. No differences were observed among groups in internal locus of control. Participants in the RGI group reported significantly higher self-practice adherence at home than did those in the CBT group.

 

• Fifty-six of the 170 patients were excluded from the analysis due to missing more than two meetings or not completing questionnaires.
• The study required a therapist trained in CBT and RGI.
• The method of recruiting participants may have affected the generalizability of the results.
• The follow-up should have been for longer periods and with more assessment points.
   

A study design with four groups—CBT, RGI, combined CBT and RGI, and control—could shed light on whether combining CBT and RGI is more advantageous than delivering either intervention individually.

To determine whether a profile-tailored cognitive-behavioral therapy (CBT) treatment program was more effective than either standard CBT or usual care in changing outcomes for patients with cancer-related pain.

Patients received standard CBT, profile-tailored CBT, or usual care. Therapy group sessions ranged from 5 to 50 minutes.

Standard CBT is comprehensive CBT that evaluates thoughts, feelings, and behaviors. It uses six to eight treatment strategies to teach patients to understand the relationship among pain, suffering, and emotions; to use symptom-coping skills, problem solving, relaxation, and self control; and to modify cognitive distortions associated with emotional distress.

Profile-tailored CBT matches patients’ scores on the Biobehavioral Pain Profile (BPP) to specific CBT modules, environmental influences, loss of control, healthcare avoidance, past and current experience, physiologic responsivity, and thoughts of disease progression.

RNs received a two-day training course to deliver the intervention.

• The study was comprised of 131 patients who were experiencing cancer-related chronic pain for more than six weeks that was associated with disease progression, adjuvant therapy, or surgical exploration.
• Mean patient age was 52 years.
• Of the patients, 72% were female, 63% were Caucasian, and 35% were African American.
• Patients had at least one elevated score on the BPP.
• The most common diagnoses were lymphoma and breast, colon, and lung cancers.

The study was conducted at one inpatient and three outpatient cancer centers in the southeastern United States.

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial.

• Brief Pain Inventory (BPI)
• Profile of Mood States (POMS)
• Karnofsky Performance Status Score (KPS)
• Medical Outcomes Study–Short Form Health Survey (MOS-SF)
• Katz Index of Independence in Activities of Daily Living (ADL)

Short-term outcome:  Based on the BPI, interference with sleep improved from baseline to immediately postintervention for the profile-tailored CBT group.

Between-group comparison of the treatment effect over the entire study found treatment effects for interference of pain with mood and sleep. Response to the intervention decreased with time.

• Poor retention was noted, with only 28 patients completing the study.
• The final sample size was very small.
• Other concepts were measured, such as fatigue, pain, bowel patterns, symptom distress, quality of life (QOL), and better KPS.
• RNs required a two-day training course to deliver the intervention.
• Space is needed to provide the intervention.

To examine the initial efficacy of a sleep therapy program developed for treating insomnia in patients with cancer.

Participants received multimodal cognitive-behavioral therapy in five weekly group therapy sessions followed by a final sixth session held four weeks later. The sessions included stimulus control therapy, relaxation training, sleep consolidation strategies, and strategies to reduce cognitive-emotional arousal. Outcomes measured included several sleep-related measures, and several European Organisation for Research and Treatment of Cancer Quality of Life Questionnare (EORTC QLQ-C30) measures, including role functioning, insomnia, and fatigue.

• The study was comprised of 14 participants, 12 of whom completed the study.
• Mean age was 54.7 years.
• Participants had mixed cancer diagnoses.
• Mean time from diagnosis was 33.6 months.

The study was conducted at outpatient clinics at a major cancer center in Ontario, Canada.
 

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

This was a repeated measure, quasiexperimental study with no control group.

• Sleep diary
• Sleep Impairment Index (SII)

Sleep improved from baseline to four weeks and to eight weeks after the intervention. Improved sleep measures included the number of awakenings, wake after sleep onset, and sleep efficiency.

• The study had a small sample size.
• The participants were relatively healthy.
• The study only used self-reported data.
• There was no placebo control group.
• The duration of effects after eight weeks was unknown.
• Space was needed to provide the intervention.

To determine the efficacy of a cognitive-behavioral intervention for treating insomnia in survivors of breast cancer.

Participants were assigned to either a multicomponent intervention with stimulus control, sleep restriction, and sleep education and hygiene or a control intervention with sleep education and hygiene. Participants attended four weekly treatment group sessions (the first session was two hours and the other three were one hour) followed by two weekly 15- to 30-minute individual telephone sessions. Outcomes measures were sleep-onset latency, wake-after-sleep onset, total sleep time, time in bed, sleep efficiency, and sleep quality.

• The study was comprised of 34 participants in the multicomponent intervention and 38 in the control group.
• Participants were women older than 18 years with a diagnosis of stage I, II, or III breast cancer and with insomnia of at least three months' duration.

The study was conducted in university and medical center classrooms.

Patients were undergoing the follow-up phase of care.

This was a randomized, controlled trial.

• Daily sleep diary
• Actiwatch®

After the intervention, based on daily sleep diaries, both groups improved in sleep-onset latency, wake-after-sleep onset, total sleep time, time in bed, sleep efficiency, and sleep quality. A between-group difference existed for time in bed. Wrist actigraph data showed significant pre- to postintervention changes for sleep-onset latency, wake-after-sleep onset, total sleep time, and time in bed. When compared to the control group, the multicomponent intervention group rated overall sleep as more improved.
 

A nonpharmacologic intervention is effective in the treatment of insomnia in survivors of breast cancer.

• The study used a selective sample:  the women were primarily white, well educated, and, on average, were diagnosed with cancer six years previously.
• Recruitment was via an advertisement and support groups; therefore, participants were more motivated to receive treatment.
• Space was required for group meetings.
• Actigraphs incurred a cost.
• The study required a Master’s level clinical nurse specialist in psychiatric-mental health nursing trained in the delivery of the intervention.

To investigate the clinical effectiveness of cognitive-behavioral therapy (CBT) for insomnia delivered by oncology nurses.

Patients received five 50-minute small group sessions delivered across five consecutive weeks, following a manualized protocol. Sessions included sleep information, sleep hygiene and relaxation, sleep scheduling, cognitive approaches, and developing a strong and natural sleep pattern. Outcomes measured were sleep, health-related quality of life (QOL), psychopathology, and fatigue.
 

• Of the patients, 100 received the CBT intervention and 50 received treatement as usual (TAU).
• Of the patients, 103 were female.
• Mean age was 61 years.
• Patients had completed active therapy for breast, prostate, colorectal, or gynecologic cancer more than one month prior and had a chronic insomnia diagnosis.

The study was conducted at two oncology clinics in Scotland.

Patients were undergoing the follow-up phase of care.

This was a randomized, controlled trial.

• Hospital Anxiety and Depression Scale (HADS)
• Fatigue Symptom Inventory (FSI)
• Functional Assessment of Cancer Therapy–General (FACT-G)
• Pittsburgh Sleep Quality Index (PSQI)
• Epworth Sleepiness Scale (ESS)
• Sleep diary
• Actigraph

CBT was associated with mean reductions in wakefulness of 55 minutes per night compared with no change in the TAU group. Outcomes were sustained six months after the intervention. There was statistically significant improvement in wake-after-sleep onset, sleep onset latency, and sleep efficiency, but not total sleep time. Actigraphy did not show statistically significant changes in sleep outcomes. CBT patients had reduced symptoms of fatigue, anxiety, and depression and increased physical and functional QOL compared to TAU patients.

• Training was required to deliver CBT.
• Space was required for group meetings.
• Actigraphs incurred a cost.

To examine the effects of six individual cognitive-behavioral therapy (CBT) sessions on sleep.

Individual CBT treatment consisted of six, one-hour weekly sessions comprised of education, behavioral components (sleep restriction, stimulus control, adhering to the sleep hygiene rules, and training in progressive muscle relaxation techniques), and cognitive interventions to counteract maladaptive thought. It also included homework assignments (sleep diaries and practicing behavioral and cognitive strategies) followed by six weeks of no-treatment follow-up. Data were collected at baseline and at the end of the first and second six-week components, and daily diary data were recorded during the treatment phase.

• The study enrolled 21 patients, and 14 finished treatment (six in the experimental group and eight in the wait-list control group).
• Mean age was 61 years (standard deviation = 11.6 years; range 45–85 years).
• All patients were female, and 12 were Caucasian.
• All patients were survivors of breast cancer who had completed treatment between 5 months and 24 years prior (mean years since completion = 6; median = 5).
• All patients met the criteria for insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).

• Single site
• San Diego, California

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

This was a randomized, controlled, crossover pilot study.

• Actigraphy (Actillume®)
• Insomnia Severity Index (ISI)
• Pittsburgh Sleep Quality Index (PSQI)
• Sleep diary
• Sleep medications list
   

After six weeks, objective data (actigraphy) showed statistically significant differences in change scores between the treatment condition group and the delayed treatment control condition group on total sleep time, wake after sleep onset, number of awakenings per night, and percent of time asleep. There was a significant decrease in insomnia in the treatment group compared to the control group. Follow-up at six weeks showed continued improvement with a clinically significant decrease in PSQI scores. Cohen’s d effect size estimate for PSQI was large (d = 0.8).

These preliminary results suggest that individual CBT is appropriate for improving sleep in survivors of breast cancer.

• The study had a small sample size.
• There was little racial/ethnic diversity among the patients.

If found to be effective, the intervention is potentially useful in several different settings.

To explore relationships among variables and evaluate change in symptoms following cognitive behavioral therapy for insomnia (CBTI)

This paper reports a secondary analysis of a randomized controlled trial of CBTI delivered in group sessions over five weeks. Assessments done at baseline and post-treatment were analyzed.

• N = 113     
• MEAN AGE: Intervention group: 65 years, range 55–69; usual care group: 58 years, range 54–66
• MALES: 26%, FEMALES: 74%
• KEY DISEASE CHARACTERISTICS: Had breast, prostate, bowel, or gynecologic cancer and had completed initial therapy
• OTHER KEY SAMPLE CHARACTERISTICS: Had chronic insomnia defined as greater than 30 minutes for delayed sleep onset or wake time after onset, insomnia three or more nights per week for at least three months and scored five or more on the Pittsburgh Sleep Quality Index (PSQI). Most were retired and were not being treated for depression. Average fatigue severity at baseline was 5, anxiety was 7–8, and depression was 4–5.

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

PHASE OF CARE: Transition phase after active treatment

Secondary analysis of a randomized controlled trial

• 10-day sleep diary
• Hospital Anxiety and Depression Scale (HADS)
• Fatigue Symptom Inventory (FSI)

The most common symptom cluster reported was insomnia, anxiety, and fatigue (18% of patients). Clinical-level insomnia was reduced by 52% in the CBTI group compared to a 17.5% reduction in the usual care controls post-intervention (p < .001). CBTI resulted in a 10.9% reduction in rate of clinical levels of fatigue, compared with a 2.5% increase in control patients post-treatment (p = .03). Anxiety rates did not change. Most patients were not clinically depressed at baseline, and no significant differences were seen between groups in depression rates post-intervention.

The CBTI reduced prevalence of insomnia and clinically relevant fatigue.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results
• At baseline, patients in the intervention group were older; no analysis was shown to determine if this difference was significant. No information is provided regarding medications or other interventions used for sleep or fatigue. Approximately 9% of the sample was lost to follow-up but from which groups is unclear.

Findings support the use of CBTI for sleep/wake disturbance and fatigue management in patients after cancer treatment. Follow-up in this report was immediately after five weeks of the intervention only, so how long-lasting any effects are is not clear.

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

• 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

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

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

• Randomized, partially blinded, noninferiority trail

• 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)

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).

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.

• 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.

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.

To compare the impact of a mindfulness-based cancer recovery (MBCR) intervention versus cognitive behavioral therapy for insomnia (CBT-I) on mindfulness and dysfunctional sleep beliefs, to examine associations of insomnia severity and changes in mindfulness and dysfunctional sleep beliefs, and to compare changes in insomnia severity between treatment groups

MBCR was used on-site at weekly 90-minute group classes with one six-hour silent retreat between weeks 6 and 7 as an opportunity for extended practice. The program consists of several types of mindfulness practices and didactic instruction on application of mindfulness attitudes. The facilitator was a nurse with more than 10 years of experience delivering MBCR. The CBT-I program consisted of eight weekly 90-minutes sessions, including stimulus control, sleep restriction, relaxation, cognitive strategies aimed at dysfunctional sleep beliefs, and sleep hygiene. The facilitator for the CBT-I program was a doctoral level trainee in a nationally accredited clinical psychology program and was supervised by a PhD-level Clinical Health Psychologist.

• N = 72  
• MEAN AGE: No sample mean
• AGE RANGE: 36–88 years
• MALES: 27.8%, FEMALES: 72.2%
• KEY DISEASE CHARACTERISTICS: The study included patients with breast, prostate, blood/lymph, female genitourinary, lung, head/neck, or colorectal cancers; and survivors with non-metastatic disease who had completed treatment at least one month prior to study participation.
• OTHER KEY SAMPLE CHARACTERISTICS: 64% were married and 58% were employed.

• SITE: Single site
• SETTING TYPE: Outpatient  
• LOCATION: University of Calgary/Alberta Health Services

• PHASE OF CARE: Late effects and survivorship

• Secondary analysis of randomized, controlled trail data
• Parent study compared MBCR with CBT-I for treatment of insomnia in patients with cancer

• Five Facet Mindfulness Questionnaire (FFMQ)
• Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)
• Insomnia Severity Index (ISI)

Mindfulness outcomes not reported. There were significant group, time, and group X time effects on overall and subscale scores for the DBAS with large effect sizes. The CBT-I group had more improvements than the MBCR group. Baseline to post-program improvements were noted that persisted at three-month follow-up. Associations between DBAS subscale and total scores and insomnia severity were not reported. Aspects of mindfulness were negatively correlated with a number of DBAS subscales and total score. Insomnia severity was negatively correlated with mindfulness non-judging. Insomnia severity (severe, moderate, mild, none) was not significantly different at baseline, post-program, and follow-up between MBCR and CBT-I groups.

CBT-I has a greater impact on DBAS measures than MBCR, but both have large effect sizes on DBAS. Aspects of mindfulness account for some variability in DBAS scores. Both MBCR and CBT-I have a positive impact on insomnia severity over time.

• Small sample (less than 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Findings not generalizable
• A number of risks for bias are unknown. The parent study is not referenced; therefore, the number of people who refused to participate or the attrition rate or allocation sequence and concealment is unknown. Analysis was per protocol. Results should be taken with caution.

Both CBT-I and MBCR may improve insomnia in survivors. CBT-I has a greater impact in decreasing dysfunctional beliefs about sleep.

To assess the combined and comparative effect of cognitive behavioral therapy (CBT) and armodafinil to improve sleep and daytime functioning in survivors of cancer.

Participants were randomized to (a) CBT-I and placebo, (b) CBT-I and armodafinil 50 mg b.i.d., (c) placebo BID, or (d) armodafinil 50 mg BID. All received written sleep hygiene guidelines. Participants had CBT-I in 30–60-minute individual, in-person sessions during weeks 1, 2, and 4; and had 15–30-minute phone sessions during weeks 3, 5, and 7. Study medicine was taken for 47 days from 7 am to 9 am and 12 pm to 2 pm.

• N = 88  
• MEAN AGE = 56 years 
• MALES: 12%, FEMALES: 88%
• KEY DISEASE CHARACTERISTICS: Patients with any cancer who completed chemotherapy and/or radiation not less than one month prior and had no measurable disease
• OTHER KEY SAMPLE CHARACTERISTICS: Patients discontinued any prescribed or OTC sleep medications one week prior to the study and for the duration of the study

• SITE: Not stated/unknown    
• SETTING TYPE: Not specified  
• LOCATION: United States and Canada

• PHASE OF CARE: Transition phase after active treatment

• Four am factorial
• Randomized and blinded trials for medications but not for CBT-I

• Quantitative data of fatigue assessment using brief fatigue inventory (BFT)
• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale

Improvement in fatigue was noted with CBT for insomnia (p = 0.002 on BFI;  p < 0.001 on FACIT-F). No improvement in fatigue was noted with placebo, on armodafinil alone, or on armodafinil with CBT-I.

CBT for insomnia appears to improve fatigue in patients with insomnia, and armodafinil was not shown to improve fatigue in patients with insomnia and fatigue.

• Small sample (less than 100)
• Study was a secondary aim of a previous trial.

This study shows that CBT for insomnia may be beneficial to patients with fatigue and that armodafinil does not improve fatigue.

To evaluate a group cognitive-behavioral intervention to alleviate menopausal symptoms (hot flushes [HF] and/or night sweats [NS]) in women who have had treatment for breast cancer.

Following a two-week daily diary assessment, patients were offered six 90-minute weekly sessions of group cognitive-behavioral therapy (CBT). CBT included:  information and discussion about menopausal symptoms; monitoring and modifying stimulants that precipitate symptoms; relaxation and paced breathing; and techniques to reduce stress and manage HF, NS, and sleep. The primary outcome measures were HF frequency and HF problem rating. Secondary outcomes included scores on the Women’s Health Questionnaire (WHQ) and scores pertaining to health-related quality of life (HRQOL) as measured by the SF-36®. Beliefs about HF were monitored to examine the effects of CBT. 

• The study was comprised of 17 women receiving group CBT.
• Mean age was 53.7 years (range 46–65).
• Of the patients, 12 (71%) had undergone breast-conserving surgery; 3 (18%), modified radical mastectomy; 9 (53%), chemotherapy; 14 (82%), radiotherapy; and 12 (71%) were taking adjuvant hormonal therapies (11 were taking tamoxifen; 1 was taking anastrozole).
• At diagnosis, seven patients (41%) were premenopausal, six (35%) were in the early or late transition stage of menopause, and four (24%) were in the early or late postmenopausal stage.
• Average time since diagnosis was 23.2 months.
• Average duration of HF and NS was 2.1 years.
• Patients were treated in groups (of six, six, and five members); 12 women (59%) attended all six sessions, three women attended five sessions, and two attended three sessions. The majority (83%) completed all assessments.

• Multisite
• Outpatient
• Clinic staff recruited patients by using a database at two breast units in London, England.

• Patients were undergoing the transition phase of care:  after initial treatment and completion of chemotherapy and/or radiotherapy and with or without hormone replacement therapy.
• The study has clinical applicability for late effects and survivorship.

The study was a single-group, exploratory trial with pre- and posttreatment assessment after six weeks and three months.

• Hot Flush Frequency and Problem Rating Scale (HFRS) 
• WHQ
• Hot Flush Beliefs Scale (HFBS)
• SF-36® HRQOL ratings
• Daily diaries
   

• Weekly frequency of HF and NS was reduced from 75.7 to 46.9 (p < 0.03) at the posttreatment measure to 38.3 (p < 0.02) at the three-month follow-up. This change represents a 38% reduction at posttreatment and a 49% reduction at the three-month follow-up.
• Problem rating was reduced from 6.3 to 3.4 at posttreatment (p < 0.0001) and to 2.6 at follow-up (p < 0.0001).
• Depressed mood and anxiety significantly decreased from assessment to posttreatment (p < 0.02), and reductions were maintained at the three-month follow-up (p < 0.03).
• Sleep improved significantly (p < 0.003).
• Subscales of the SF-36® showed other significant improvements:  emotional role limitation (p < 0.0001), mental health (p < 0.01), energy/vitality (p < 0.0001), and general health (p < 0.003).
• Total scores on the HFBS decreased significantly, from 28.2 to 22.4 at posttreatment (t = 3.77; df = 16; p < 0.002), and were maintained at 22.7 at follow-up (t = 4.34; df = 16; p < 0.001). These reductions reflected a significant change in beliefs.

• Results suggest that CBT delivered in groups might offer a viable option for women with troublesome, undertreated, menopausal symptoms following breast cancer treatment, but further controlled trials are needed.
• CBT is consistent with the preferred treatment of women surveyed.
• Improvements continued after treatment, which may reflect the skills-learning aspect of CBT. HF and NS decreased, as did depressed mood and anxiety.
• Sleep improved, as reported by changes in WHQ ratings.
• Results showed no signficant improvement in specific dimensions of HRQOL, particularly emotional role limitation, energy/vitality, or mental health.

• The study had a small sample size, with less than 30 patients.
• The study is of limited generalizability.
• The main limitations of the study were lack of controls for placebo effects, attention, and spontaneous remission.
   

Nurses could be trained to conduct structured, interactive, group CBT with individual treatment goals. A randomized, controlled trial is recommended for further investigation.

The purpose was to examine whether tai chi chih (TCC) is noninferior in effect to cognitive behavioral therapy (CBT-I) in reducing insomnia in breast cancer survivors.

Participants were randomly assigned to two groups: those receiving CBT-I and those receiving TCC. Prior to the intervention, participants were enrolled in a 2-month phase-in period to establish their degree of insomnia. CBT-I and TCC groups were comprised of 7-10 participants and consisted of weekly 120-minute sessions. Interventions were held over two months, with a third month of skill consolidation and adherence (three months total intervention exposure). Remission of insomnia was also measured by an interviewer blinded to intervention exposure who evaluated remission according to DSM-IV-TR criteria. Assessments  of insomnia, a daily sleep diary, polysomnography levels, levels of fatigue, sleepiness, depressive symptoms, body mass index, and physical activity levels were collected at month 2 (baseline data), month 3 (post intervention), and follow-up assessments at months 6 and 15.

• N: 90   
• AGE: Range = 42-83 years, Mean = 59.6
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Breast cancer survivors met the DSM-IV-TR criteria for insomnia had reported sleep difficulties at least 3 times or more per week for at least three months or more; had finished surgical, radiation, or chemotherapy treatment at least 6 months prior; and did not have recurrence of cancer or a new tumor.

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: Los Angeles, CA

PHASE OF CARE: Late effects and survivorship

Two groups were established in a randomized, partially blinded, noninferiority trial. Participants were blinded to the hypothesis and the alternate treatment group.

• Sleep quality was measured using the Pittsburgh Sleep Quality Index and Athens Insomnia Severity Index. 
• Objective sleep continuity was measured using polysomnography and subjectively with sleep diaries. 
• For secondary outcomes, insomnia remission was evaluated using DSM-IV-TR criteria and reviewed utilizing board-certified psychiatrists and psychologists. Fatigue was measured using the Multidimensional Fatigue Symptom Inventory, sleepiness was measured using the Epworth Sleepiness Scale, and depressive symptoms were measured using the Inventory of Depressive Symptoms. Body mass index and physical activity levels (Yale Physical Activity Survey) were also measured. A noninferiority margin of 50% was used.

Responsiveness to CBT-I or TCC treatment was comparable with a responsiveness rate of 43.6% and 46.7%, respectively. The noninferiority margin for this study’s purposes was set at 50%, and noninferiority of TCC was observed at month 3 (p = 0.02), month 6 (p =< 0.01), and month 15 (p = 0.02). Both treatments resulted in comparable insomnia remission rates at month 15 (46.2% and 37.9%, respectively). Differences in change of PSQI or AISI, as well as change in sleep time and wake after sleep onset, and effects on fatigue, sleepiness, or depression from baseline were not significant in comparing treatment groups (p > 0.3, p > 0.4, p > 0.5, respectively). PSG did not demonstrate treatment effects or differences across groups of significance.

CBT-I and TCC demonstrated high patient responsiveness and sustainable insomnia reduction at follow up yet yielded nonsignificant differences between treatment groups, thereby demonstrating noninferiority of TCC to CBT-I. Improvements in sleep quality, fatigue, sleepiness, and depressive symptoms were observed among both groups, but group differences were again not significant.

• Small sample (< 100)
• Findings were not generalizable.
• Intervention was expensive and impractical, and training was needed.
• Subject withdrawals ≥ 10%

Given not only the prevalence, but debilitative effect insomnia has on patients with cancer, alternative treatments to CBT-I, such as TCC, are important for nurses to assess and identify for patients, who may have variances in access to clinical CBT-I treatment.

To investigate whether cognitive-behavioral therapy (CBT) can help survivors of breast cancer in effectively managing menopausal symptoms.

The intervention consisted of six 90-minute weekly sessions with group discussions, handouts, weekly homework, and paced breathing and relaxation practice—along with an audio CD to practice paced breathing and relaxation at home daily—in addition to usual care. The control group received usual care and follow-up by an oncologist or clinical nurse specialist every six months. Assessments took place at baseline, nine weeks after randomization (typically two weeks after treatment), and 26 weeks after randomization. All sessions were audio recorded, and a 10% random sample of the tapes was reviewed to evaluate the intervention.

• The study enrolled 88 English-speaking women with breast cancer who were randomized into blocks, stratified by age (younger than 50 years and 50 years or older).
• Patients reported a minimum of 10 problematic episodes of hot flashes per week for a duration of two months or more.

• Mutlisite
• Outpatient
• Breast clinics in London, England

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

This was a triple-blinded, randomized, controlled trial.

• Sternal Skin Conductance (SSC) for physiological symptoms from hot flashes  
• SF-36® health-related quality-of-life ratings
• Women’s Health Questionnaire (WHQ)
• Adherence was measured by the number of sessions attended and the number of times that a patient practiced relaxation or paced breathing each week.

Night sweats problem rating scores at 9 and 26 weeks were lower in the CBT group than they were in the usual care group, with a mean difference between groups of –1.67 (95% confidence interval [CI] [–2.43, –0.91]; p < .0001). These scores also declined over time in the control group. There were no differences between groups in hot flush frequency, night sweats frequency, or SSC measures. Those receiving the CBT intervention reported less sleep problems (adjusted mean difference (AMD) = –0.16; 95% CI [–0.29, –0.02]), anxiety (AMD = –0.16; 95% CI [–0.29, –0.02]), and better memory and concentration (AMD = –0.14; 95% CI [–0.26, –0.02]).

The findings suggest that group CBT improved patients’ perceptions of the degree to which hot flashes were a problem but did not appear to affect the actual frequency or objective measures of hot flashes. Group CBT appeared to have a small size of effect on sleep problems, anxiety, and other self-reported outcomes.

• The study had a small sample size, with less than 100 patients.
• No attentional control was used.
• Specific AMD calculation was not described, so it is not clear how well this represents an effect size. 
• Measures for anxiety and other outcomes were limited.

This study provides some supportive evidence for the benefit of cognitive-behavioral approaches. Group CBT may have a benefit in managing hot flashes and other symptoms through altered perceptions of the degree to which these symptoms are seen as problematic. Health professionals, such as breast cancer nurses or clinical nurse specialists trained in CBT, can improve long-term health outcomes for patients with breast cancer, and CBT could be incorporated into breast cancer survivorship programs. 

To examine the effect of cognitive behavioral therapy (CBT) on sleep-wake outcomes in breast cancer survivors

Women who met criteria for chronic insomnia and had completed breast cancer treatment randomly were assigned to CBT intervention or a placebo behavioral intervention. Individual, weekly CBT sessions consisted of education, stimulus control, sleep hygiene education, and cognitive therapy provided by an advanced practice nurse with specialized training. The placebo intervention was based on desensitization therapy that had been used in previous insomnia trials as a placebo treatment. For both groups, sessions 1, 3, and 6 were provided in person, and sessions 4 and 5 were provided by telephone. Sessions were audiotaped and independently reviewed by a CBT therapist to ensure fidelity. Women were evaluated at three- and six-month follow-ups.

• N = 56
• MEAN AGE = 52 years
• FEMALES:100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer and were 1–36 months post-initial treatment. Most had previous radiation and chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: The majority were Caucasian, well educated, and employed part- or full-time.

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

• PHASE OF CARE: Late effects and survivorship

• Randomized, single-blind RCT with attention control

• Sleep diary
• Piper Fatigue Scale
• Hospital Anxiety and Depression Scale
• Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16)
• Patient knowledge test
• ISI measure of perceived insomnia
• Attentional function index
• EORTC-QLQ-C30

The CBT group did not show a significantly greater improvement in sleep outcomes immediately after the intervention, but scores were significantly better by the follow-up period (p = .003). Sleep efficiency increased by more than 11% in the CBT group, compared to an increase of 6.34% in the control group (d = 0.63). Sleep latency also improved more in the CBT group (d = 0.48, p = .007). No differences between groups were found for anxiety, depression, or fatigue.

Findings show that patients receiving CBT for sleep improved several sleep outcomes compared to individuals receiving a control intervention. The intervention did not demonstrate an effect on anxiety, depression, or fatigue.

• Small sample (less than 100)
• Findings not generalizable
• Other limitations/explanation: The sample had little diversity. The average baseline scores suggested that patients did not have clinically relevant levels of anxiety or depression.

Results of this study provide evidence of a moderate and significant effect of CBT on sleep outcomes among breast cancer survivors. This adds to the body of evidence that suggests effectiveness of this approach in managing sleep-wake disturbances.

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.

The study used a two-phase, multimodal, cognitive-behavioral therapy (CBT) combined strategy:  (a) over 3 to 10 weeks and (b) over eight weeks; eight weekly sessions lasted 90 minutes.

The purposes were to establish treatment objectives, stimulus control, sleep restriction, coping strategies for fatigue, and reframe maladaptive cognitions.

Outcomes were sleep, mood, fatigue, and global and cognitive quality of life (QOL).

• The sample was comprised of 10 women with nonmetastatic breast cancer (stages I–III).
• Mean age was 54.3 years.
• Women completed chemotherapy and/or radiation therapy.
• All had a diagnosis of chronic insomnia disorder per the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
• All had completed high school.

• Single site
• Patients were recruited from the community sleep laboratory and subjects’ homes.
• Quebec, Canada

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

The study used a prospective, nonrandomized, repeated measures, quasiexperimental, single-case design comparing each individual over time.

• Insomnia Interview Schedule (ISI) 
• Sleep diary
• Self-report scales
• Polysomnography and breathing parameters

Most women experienced a statistically significant improvement in sleep efficiency and decreased total wake time pre- and posttreatment. Sleep efficiency continued at the six-month follow-up, but total wake time did not. Findings on sleep diaries were corroborated by objective measures.

• The study had a small sample size.
• The sleep diaries were incomplete.
• The potential existed for influence factors, such as intragroup alliance and empathy.
• Sleep improvement may be an effect of time away from cancer therapy.
• A trained psychologist must administer the tests; in addition, cost is incurred by using a sleep laboratory for polysomnography.

To determine the feasibility and efficacy of an internet-based, cognitive-based therapy (CBT-I) program—Sleep Healthy Using the Internet (SHUTi)—to improve insomnia symptoms in cancer survivors.

To explore whether an internet-based CBT-I intervention would improve fatigue, mood, and quality of life (QOL).

Patients completed preassessment questionnaires and sleep diaries for 10 days over a two-week period. Patients randomized to the intervention group were enrolled in the SHUTi program. They were given nine weeks to complete six interactive core programs, each lasting about 45 to 60 minutes. During the program, they entered daily sleep diary information. The first core, “Overview,” introduced the SHUTi program, and the next two cores, Behavior 1 and Behavior 2, introduced sleep restriction and stimulus control. The “Education” core focused on sleep hygiene, and the “Sleep Thoughts” core helped users identify and restructure faulty beliefs about sleep. Lastly, patients received “Problem Prevention,” which covered relapse prevention. Upon completion, all patients completed postassessment questionnaires and sleep diaries for 10 days. 

• The sample was comrprised of 28 patients (14% male, 86% female).
• Average age was 56.7 years (standard deviation = 11.7 years).
• Patients were cancer survivors of all types who had, on average, completed treatment about four years prior to the study. Of the patients, 46% had stage I cancer and 21% had stage II cancer.
• On average, the patients had completed 17 years of education, were married (79%), and were white (93%).
• Of the patients in the internet group, 100% were women. In addition, 93% of the internet group had a diagnosis of breast cancer, compared to 36% in control group.

• Patients were recruited from postings at a university cancer center and the surrounding community.
• Home  
• Virginia

• Patients were undergoing the long-term follow-up phase of care.
• The study has clinical applicability for survivorship.

The study was a randomized, controlled trial with a wait-list control.

• Insomnia Severity Index (ISI)
• Sleep diary - self-report
• Multidimensional Fatigue Symptom Inventory–Short Form (MFSI-SF)
• Hospital Anxiety and Depression Scale (HADS)
• Social Funcitioning Health Survey (SF-12)

The internet group showed marked improvement in insomnia severity from pre-/postassessment, and the control group showed no significant change (p < 0.01). The internet group ISI score decreased from 17.1 preassessment to 8.2 postassessment (p < 0.01), and control group scores showed no significant changes from preassessment (15.9) to postassessment (14.4). In addition, the internet group showed clinically significant changes, pre-/postintervention, with 64% having clinically significant insomnia preintervention to 14% having clinically significant insomnia postintervention. Postintervention, 50% of internet group scored “no insomnia” versus 14% in the control group. Effect size for insomnia severity, sleep efficiency, sleep onset latency (SOL), and wake after sleep onset (WASO) were all d > .72.

Improvements were also shown in sleep efficiency and SOL for the internet group. No effect was noted in total sleep time, WASO, and time in bed.

Improvements were seen in the internet group's overall fatigue scores over time (p < 0.01), especially when compared to the control, who showed no improvement over time. There were no significant changes in HADS scores or the SF-12 QOL scores over time or between groups.  
 

An internet-based CBT-I intervention is feasible and efficacious in improving insomnia and fatigue in some cancer survivors in a small sample of highly educated, white, married women. 

• The study had a small, self-selected sample.
• A large percentage of the patients were highly educated, white, married women with breast cancer. The study is not generalizable.

There seemed to be excellent response to this intervention in this population. However, a wider study with a more diverse sample is required.

To test the short-term efficacy of a video-based delivery of cognitive behavioral therapy for insomnia compared to a professionally administered method and a no-treatment group

Patients with breast cancer postradiation therapy who were 18 months post-treatment with insomnia were randomized into one of three groups: a video-based cognitive behavioral therapy intervention (VB-CBTI) (60 minute video with six booklets), a professionally delivered CBTI (six weekly, 50-minute, in-person sessions), or a no-treatment group.

• N = 242
• MEAN AGE = 54.4 years (SD = 8.8 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer; 18 months postradiation therapy for nonmetastatic cancer; poor sleep defined by Insomnia Severity Index scores; sleep medication use
• OTHER KEY SAMPLE CHARACTERISTICS: Able to read French; no cognitive impairments; no psychiatric disorders; no prior diagnoses of sleep disorders other than insomnia; no nightshift work; no psychotherapy for insomnia; no language, hearing, or visual deficits; 25.6% taking antidepressants; 31% taking anxiolytics; 73% receiving hormone therapy

• SITE: Single-site
• SETTING TYPE: Outpatient    
• LOCATION: Canadian oncology and radiology department (academic)

• PHASE OF CARE: Transition phase after active treatment

Randomized, controlled, three-arm intervention study

• Mini Mental State Exam (MMSE)
• Structured Clinical Interview for DSM Disorders (SCID)
• Insomnia Severity Index (ISI) (pretreatment)
• Sleep diary
• Multidimensional Fatigue Inventory (MFI)
• Hospital Anxiety and Depression Scale (HADS)
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (​EORTC-QLQ C30)
• Dysfunctional Beliefs and Attitudes Scale (DBAS)
• Actigraphy secondary outcomes

Group-by-time interactions were significant for sleep variables with video-based CBTI being associated with greater sleep improvements compared to the control group for sleep variables other than early-morning awakening and total sleep time (p < 0.001). There were no significant differences between in-person and video-based CBTI for sleep onset latency, wake after sleep onset, total wake time, and sleep efficiency. In-person treatment was associated with a greater reduction in ISI scores, early morning awakening, and total wake time compared to video-based CBTI. The magnitude of change over time was greater with in-person CBTI compared to video CBTI. Both interventions demonstrated a greater improvement in sleep outcomes than the control group. Actigraphy showed a significant reduction (pre/post) in the in-person group only. Secondary outcomes among the in-person group included a significant reduction in depression (p < 0.001), fatigue (p < 0.001), and dysfunctional beliefs about sleep (p < 0.001).

Both CBTIs were effective in improving sleep compared to usual care. The video format seems to be an effective treatment option, but in-person therapy continues to show better efficacy. CBTI also was associated with improvements in fatigue and depression scores.

• Subject withdrawals ≥ 10%
• Other limitations/explanation: There always is a risk for treatment contamination with randomized, controlled trials. This study was limited to patients who received radiation treatment and those willing to participate in CBTIs, which limits generalizability. There were significant baseline differences in the numbers of participants taking anxiolytics on a regular basis with the highest proportion concentrated in the control group; this could have led to an underestimation of the results of the intervention alone.

CBTIs can be challenging to implement because access to care for patients with cancer is varied. Although in-person therapy was most effective, the video-based intervention also was effective in improving sleep, fatigue, and depression outcomes. Providing options to rural populations without access to in-person care is essential for increasing efficacy in a wider population with insomnia. The findings of this study regarding the efficacy of a video-based CBTI provide nurses with another option that warrants its use as a treatment with longer effects.

To assess the long-term efficacy of a video-based behavioral therapy for insomnia (VCBT-I) as compared to a professionally administered intervention (PCBT-I) and to a no treatment group (CTL).

Participants were randomized to receive one of two types of CBT for insomnia or a control arm with no intervention. The PCBT-I arm received six weekly individual treatment sessions (50 minutes each) with a companion booklet at each session. This was administered by a psychologist or PhD student with CBT experience. The VCBT-I group received a 60-minute video, and they were instructed to watch 5–20 minutes each week and to read a companion booklet each week. They had telephone access to a licensed psychologist if they had questions. All received pre- and postintervention evaluations, as well as long-term follow-up evaluation at 3, 6, and 12 months.

• N = 242  
• AGE = 54.4 years (SD = 8.8 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Study participants had breast cancer within 18 months of completing radiation with insomnia symptoms or using hypnotic medications.  
• OTHER KEY SAMPLE CHARACTERISTICS: 63.9% were married and 92.8% were peri- or postmenopausal.

• SITE: Single site    
• SETTING TYPE: Outpatient  
• LOCATION: Quebec University Hospital, Canada

• PHASE OF CARE: Transition phase after active treatment

• Three-arm randomized, controlled trial

• Insomnia Severity Index (ISI)
• Daily sleep diary: sleep onset latency (SOL), wakefulness after sleep onset (WASO), early morning awakenings (EMA), total wake time (TWT), total sleep time (TST), sleep efficiency (SE) ratio of total sleep time: time spent in bed, and usage of hypnotic medications
• Multidimensional Fatigue Inventory (MFI)
• EORTC Cancer Quality of Life Core 30 (EORTC-QLQ-C30) global quality of life score, item #13
• Dysfunctional Beliefs and Attitudes about Sleep (DBAS)

Post-treatment to follow-up in PCBT-I arm showed significant increase in EMA and TST. The VCBT-I group showed a significant increase in WASA. The control arm showed a significant increase in all sleep variables. There was a reduction, albeit nonsignificant, in the use of hypnotics in the PCBT-I arm, a significant reduction in the VCBT-I arm, and an increase in the control arm. Insomnia remission rates were significantly higher for the PCBT-I group at three and six months when compared to the VCBT-I group. No difference existed at 12 months.

The PCBT-I and VCBT-I groups showed immediate and sustained improvement in several sleep outcomes at three- and six-month follow-ups. When compared, the face-to-face intervention was superior to the video-delivered intervention. The remission rate remained highest in the PCBT-I group. With that said, results should be interpreted with caution because of secondary to selection bias, attrition with significant differences in those who dropped out, and differences in study groups.

• Risk of bias (sample characteristics)
• Selective outcomes reporting
• Findings not generalizable
• Subject withdrawals at 10% or greater
• Not controlling for hypnotic use could affect outcomes/breast cancer only.
• Only 20% of eligible participants agreed to participate, suggesting selection bias.

Further study is needed to document alternative ways to deliver CBT interventions for improving sleep outcomes. Personalized 1:1 CBT appears to be the most effective, although when resources are limited, a video-based intervention can be substituted and does show efficacy.

The study included eight (60- to 90-minute) weekly sessions of cognitive therapy (CT), followed by three booster sessions given at three-week intervals. The focus of therapy was aimed at developing an optimistic but realistic attitude toward their situation as opposed to a negative or overly positive attitude. 

Patients were randomly assigned either to the (1) CT group or the (2) waiting list control (WLC) condition.

Outcomes were depression, anxiety, insomnia, fatigue, quality of life (QOL), and immunological measures.

The sample was comprised of 45 Caucasian women with metastatic breast disease (stage IV) with depressive symptoms determined by Hospital Anxiety and Depression Scale–Depression (HADS-D) scores.

The study was conducted at three Canadian cancer clinics.

Patients were undergoing the active treatment phase of care.

The study was a two-group clinical trial with a WLC.

• Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
• Scale for Suicide Ideation (SSI)
• HADS
• Beck Depression Inventory (BDI)
• Hamilton Depression Rating Scale (HDRS)
• Insomnia Severity Index (ISI)
• Multidimensional Fatigue Inventory (MFI)
• European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C33)
• EORTC Breast Cancer Specific QOL Questionnaire Module (EORTC QLQ-BR23)
• Health Behavior Questionnaire (HBQ)
• List of Life Events (LLE)
• Immunologic Measures included lymphocyte subpopulations, natural killer cell activity, and cytokine secretion.
   

Although the group comparison was statistically significant on the HDRS measure only, comparison of means of other measures (BDI and HADS-D) revealed a reduction in depression scores in the treatment group versus the control group. In pooled group analysis, these gains were sustained. Also, when using the pooled data set only, the authors found decreased anxiety, fatigue, and insomnia symptoms. No treatment effect was found on the immune variables.

The study supports the efficacy of using CT for treating depressive symptoms in women with metastatic breast cancer.
 

• The study had a small homogenous sample.
• Patients were not severely depressed, which left less room for improvement.
• A licensed psychologist trained in CT is required to deliver treatment.

The study included eight weekly 90-minute group sessions of combined behavioral (stimulus control and sleep restriction), cognitive (cognitive restructuring), and educational (sleep hygiene, fatigue, and stress management) strategies.

Outcomes were sleep, medication use, psychological distress, and quality of life (QOL).

Patients were recruited from the community by advertisement.

The sample was comprised of 57 women who had completed radiation and chemotherapy for stage I to III breast cancer and met Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for a chronic insomnia syndrome.

Canada

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

The study was a two-group clinical trial with a wait-list control.

• Insomnia Interview Schedule (IIS)
• Structured Clinical Interview for DSM-IV
• Sleep diary
• Polysomnography
• Insomnia Severity Index (ISI)

Treated patients showed a significantly greater improvement in sleep posttreatment as assessed by self-reported instruments. However, data from polysomnography were not significantly more improved. Treated patients reduced use of sleep medication.

• The sample was homogeneous (i.e., all white), with most being highly educated, and included a self-selected study group.
• The study used a wait-list control.
• A Master’s-level psychologist who has experience in the administration of this treatment protocol must be included.

To determine feasibility and assess patient satisfaction with a self-administered format of cognitive-behavioral therapy (CBT) for insomnia comorbid with cancer.

To provide initial information on the effect of self-administered CBT on subjective measures of sleep and other symptoms.

Patients were given a battery of self-report scales to complete for baseline evaluation and were then contacted by an interviewer. They underwent a 75-minute interview followed by instructions to complete a sleep diary for two weeks. Then, patients were given the self-help CBT module for insomnia. It was comprised of six modules, each with a video segment and booklet covering the following topics on sleep and insomnia:  (1) insomnia facts, (2) stimulus control therapy and sleep restriction strategies, (3) cognitive restructuring strategies, (4) revision of maladaptive sleep cognitions, (5) sleep hygiene, and (6) relapse prevention strategies. They were instructed to read one module per week for six weeks. At posttreatment and follow-up, they completed the same battery of self-report scales and sleep diaries.

• The sample was comprised of 11 female patients; seven participated in three-month follow up.
• Mean age was 51.5 years (range 37–74).
• Patients had received radiation therapy for breast cancer; 7 of 11 were undergoing active treatment versus 4 of 11 who had completed therapy 10 to 60 months before the study.
• Patients had insomnia symptoms (score of ≥8 on the Insomnia Severity Index [ISI]) or used psychotropic medications for sleep at least three nights per week.
• Patients were excluded if they had metastatic disease, cognitive impairment, or major mental or psychiatric illness.

• Single site  
• Outpatient
• Quebec radiation oncology clinic

Patients were undergoing the transition phase after initial treatment.

The study used a single-group, nonrandomized pre-/post design.

• Treatment Perception Questionnaire (TPQ)  
• Treatment Satisfaction Interview
• Insomnia Severity Index (ISI)
• Morin Sleep Diary
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
• Hospital Anxiety and Depression Scale (HADS)
• Multidimensional Fatigue Inventory (MFI)

All patients adhered to the treatment, and all found the format to be excellent and interesting. All patients reported subjective improvement in their sleep quality and motivation to continue the strategies in the future. Sleep measures showed effect sizes of large magnitude in total ISI score, wake after sleep onset, sleep onset latency, sleep efficiency, and total DBAS score. There were moderate effect sizes of HADS–Depression (HADS-D) and QOL scores, with small effect sizes for total sleep time, hypnotics usage, HADS–Anxiety (HADS-A), and MFI scores. These results were sustained at three months.

A self-help CBT strategy for insomnia in patients with breast cancer is feasible. It appears to improve sleep outcomes and dysfunctional beliefs and may improve QOL and depression.

• The study had a small sample size, with less than 30 patients.
• The study had a high drop-out rate; only 7 of 11 patients completed all evaluations at all timepoints.
• The study lacked a control group, and the study was underpowered.

Self-administered CBT for insomnia may be a good first line strategy to treat insomnia in patients with cancer. It allows for treatment at a time that is convenient to the patient and for improved access to care because it can be performed without a sleep expert present.

10-week CBSM

• N = 240
• MEAN AGE = 50.99 years for CBSM and 49.69 years for psychoeducational control group 
• FEMALE: 100%
• KEY DISEASE CHARACTERISTICS: Patients with early-stage breast cancer (stage III and below) who had completed surgery (lumpectomy or mastectomy) prior to randomization

• SITE: Not stated or unknown  
• SETTING TYPE: Not specified  
• LOCATION: Southern Florida

• PHASE OF CARE: Active anti-tumor treatment

• Experimental (random assignment)

• Pittsburgh Sleep Quality Index (PSQI)
• Fatigue Symptom Inventory (FSI)

No statistical differences in PSQI total scores or changes in fatigue intensity between groups. Changes in sleep quality were associated with change in fatigue.

CBSM may have some positive effects on elements of sleep quality and fatigue. Data support an association between sleep quality and fatigue (fatigue-related daytime interference).

• Risk of bias (no appropriate attentional control condition)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Intervention expensive, impractical, or training needs
• Questionable protocol fidelity
• Subject withdrawals were 10% or greater

Consider evaluation of sleep disturbance in patients experiencing fatigue.