Cognitive Behavioral Interventions/Approach for Sleep

STUDY PURPOSE: To review the published evidence on non-pharmacologic interventions for fatigue in men with prostate cancer

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: PubMed, PsycINFO, CINAHL, Cochrane Central Trials Register and Embase, PsychExtra, SIGLE, Australian New Zealand Clinical Trials Registry, ClinicalTrials.gov, World Health Organisation International Clinical Trials Registry Platform, EU Clinical Trials Register, MedNar, and reference lists of articles included in review

KEYWORDS: key concepts of prostate cancer, fatigue, non-pharmacological and nursing management, and various interventions; detailed search for PubMed included as appendix

INCLUSION CRITERIA: Adult men older than 18 years with prostate cancer at any stage of treatment; non-pharmacologic interventions including exercise, exercise with diet and lifestyle modification, education, and cognitive behavioral therapy; comparison to other non-pharmacologic interventions or usual care; experimental studies; fatigue as primary outcome of interest using existing validated tools to measure

EXCLUSION CRITERIA: Not stated

TOTAL REFERENCES RETRIEVED = 1,480

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two independent reviewers appraised studies; validity assessed with Johanna Briggs Institute Critical Appraisal Checklist for Randomised and Pseudo-Randomised Studies

• FINAL NUMBER STUDIES INCLUDED = 8
• SAMPLE RANGE ACROSS STUDIES: 21–240
• TOTAL PATIENTS INCLUDED IN REVIEW = 600
• KEY SAMPLE CHARACTERISTICS: Undergoing treatment for prostate cancer or completed treatment within past 12 months; age range 46–86 years

PHASE OF CARE: Multiple phases of care     

APPLICATIONS: Elder care

All studies were of high methodologic quality. Four out of five studies measuring physical activity found statistically significant fatigue reduction; the other study showed a trend toward fatigue reduction. Two studies concluded that cognitive behavioral therapy was effective in managing cancer-related fatigue. Two studies looking at education had mixed results. Brief nursing education was not significant in reducing fatigue, but intensive prostate-specific education was significant.

This report supports physical activity for managing cancer-related fatigue. Cognitive behavioral therapy and intensive focused education are also likely to be effective.

• Only eight studies included
• Variety in delivery of interventions and measurement of fatigue

Nurses should continue to recommend physical activity for management of cancer-related fatigue. Cognitive behavioral therapy and intensive education may be considered.

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 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 effectiveness of a behavioral therapy (BT) intervention, an individualized sleep promotion plan (ISPP), on sleep quality and fatigue in women with breast cancer receiving adjuvant chemotherapy.

Participants were recruited and screened for eligibility between 2003 and 2006. Eligible women interested in participation were visited by a research nurse who completed the randomization procedure, administered baseline questionnaires, and had patients wear an actigraph two days prior to the initial treatment. The intervention was delivered by research nurses who were trained by a sleep psychologist.

Those assigned to the BT group developed a 120-item ISPP with the research nurse according to the nurse's review of responses to measures to identify areas of sleep difficulty. Advice and information was tailored to individual needs. Revisions to the ISPP were made in 30-minute appointments made with participants two days prior to each treatment and 30 days after the last treatment. Reinforcement of the plan was made in 15-minute appointments seven days after each revision. Each ISPP included

• Modified stimulus control
• Modified sleep restriction
• Relaxation therapy
• Sleep hygiene counseling.

Patients in the control group received equal time and attention at each home visit and were provided with general support and a discussion of a new healthy eating topic.

• In total, 217 patients (100% female) completed the study and were analyzed.
• Mean age was 52.14 years (range 29–83). 
• All patients had breast cancer.
• All patients were receiving adjuvant chemotherapy.
• In each study group, 14% of patients had cancer stage above II, at IIIA.
• Of the patients, 75% had at least some college education.
• The majority of the patients were employed outside the home.
• Patients were excluded if they had a self-reported comorbidity associated with poor sleep and fatigue.

Multisite

This was a randomized, controlled study.

• Symptom Experience Scale (SES) to measure the distress experiences of nausea, pain, appetite, bowel pattern, concentration, and appearance
• Hospital Anxiety and Depression Scale (HADS)
• Medical Outcomes Study Short Form General Health Survey, version 2 (MOS-SF-36-v2)
• Piper Fatigue Scale (PFS):  22-item scale, Crohnbach’s alpha = 0.93-0.98
• Pittsburgh Sleep Quality Index (PSQI):  Crohnbach’s alpha = 0.74-0.83
• Daily sleep diary
• Wrist actigraph to quantify continuous monitoring of body movement for total sleep time after onset and sleep efficiency:  percent of time asleep after falling asleep out of total time in bed, number of awakenings, and time and percent of time awake after sleep onset

Baseline sleep quality measures indicated mild fatigue, somewhat poor sleep quality, low levels of symptom distress, and normal anxiety and depression levels. PSQI scores indicated lower sleep quality than the general adult population but better scores than those previously associated with poor sleep quality in patients with breast cancer. There were significant differences over time on all sleep variables from the diaries and actigraphs (p < 0.01). Diaries showed a significantly lower number of awakenings (p = 0.032), a lower average amount of time awake while in bed (p = 0.027), and higher sleep efficiency (p = 0.001) in the BT group.  Fatigue scores in both groups increased during treatment and decreased after treatment ended (p < 0.0001). This pattern was similar in both study groups. Perceived fatigue was similar between the two groups. There was a trend of improved sleep quality over time (PSQI) in the BT group.

The four-component ISPP was associated with improved sleep quality over time, better sleep efficiency, and fewer awakenings. Findings suggested that perceptions of improved sleep quality were not consistently associated with diary entries or objective sleep measures.

• Study participants tended to have relatively good sleep quality and low fatigue prior to chemotherapy compared to other reported patients with breast cancer. This may have reduced the effects seen and makes the clinical impact of findings unclear.
• The study ended 30 days after the last treatment; therefore, the longer-term effectiveness cannot be determined.
• The intervention was provided by trained nurses rather than sleep specialists, which may have affected the findings.
• The relative effectiveness of nurse-delivered BT has not been examined.

To determine the effects of a behavioral therapy (BT) sleep intervention (individualized sleep promotion plan [ISPP]) on cancer-related fatigue over a one-year period in women receiving adjuvant chemotherapy for breast cancer.

Patients at each study site were stratified according to number of planned anthracycline-based treatments and good versus poor sleep quality. Patients were then randomly assigned to the ISPP group or a control group that received care regarding health eating (HEC), which received the same amount of individual time and attention as the ISPP group. At baseline, patients in the ISPP group spent 90 minutes with the research nurse to develop a 12-item ISPP plan. Two days before all treatments, they spent another 30 minutes with the research nurse revising the plan based on sleep diaries and plan adherence data. After each revision, plans were reinforced in a 15-minute, in-person session seven to nine days after the revision. Plans included

• Stimulus control
• Modified sleep restriction
• Relaxation therapy
• Sleep hygiene counseling.

Thirty-minute sessions were held to revise the BT plan again at 30, 60, and 90 days after the last chemotherapy treatment. HEC participants received in-person sessions of equal time and attention before each treatment and at 30, 60, and 90 days after the completion of chemotherapy.

• In total, 217 patients (100% female) completed the study and were analyzed.
• Mean age was 52.14 years (range 29–83).
• All patients had breast cancer.
• All patients were receiving adjuvant chemotherapy.
• In each group, 14% of the patients had a cancer stage above II, at IIIA.
• Of the patients, 75% had at least some college education.
• The majority of patients were employed outside the home.
• Patients were excluded if they had a self-reported comorbidity associated with poor sleep and fatigue.

• Multi-site
• Twelve oncology clinics

This was a randomized, controlled trial with a one-year follow-up.

• Symptom Experience Scale (SES) to measure distress experiences of nausea, pain, appetite, bowel pattern, concentration, and appearance
• Hospital Anxiety and Depression Scale (HADS)
• Medical Outcomes Study Short Form 36 General Health Survey, version 2 (MOS-SF 36-v2)
• Piper Fatigue Scale:  22-item scale, Crohnbach’s alpha = 0.93-0.98
• Pittsburgh Sleep Quality Index (PSQI):  Crohnbach’s alpha = 0.74-0.83
• Daily sleep diary
• Wrist actigraph to quantify continuous monitoring of body movement for total sleep time after onset and sleep efficiency:  percent of time asleep after falling asleep out of total time in bed, number of awakenings, and time and percent of time awake after sleep onset

The BT group had a significant improvement in sleep quality compared to the HEC group at 90 days (p = 0.002) but not at one year (p = 0.052). Higher fatigue (p = 0.027) and higher anxiety (p = 0.012) at baseline were associated with poorer sleep at one year. There were no differences in most diary and objective sleep findings at selected times over the year. Sleep diary and actigraph findings did not coincide for either group. Values recorded in the diaries tended to show better sleep time and percent and lower numbers of awakenings than the actigraph findings. Moderate to severe fatigue was reported at one year by 20% of patients in the BT group and 24% in the HEC group. Fatigue changed over time for both groups, but there were no significant differences between the groups. PSQI scores over time were significantly better in the BT group (p = 0.013).

The BT intervention improved global sleep quality but did not improve fatigue in women over a period of one year. Baseline anxiety was associated with higher fatigue and poor sleep at one year.

• Participants had relatively mild sleep disruptions at baseline, which may have limited the effect and effect size of the sleep and fatigue scores.
• Differences in patient perception by diary and actigraph findings were not explained.
• The coscientist model used in the BT group incorporated participant freedom to design their own BT plan. A drawback of this approach was that patients often chose strategies with easier habits to alter than those that might be most effective.
• There was limited diversity in the sample demographics in terms of ethnicity and education level.

Patients received a multi-component, cognitive-behavioral therapy (CBT), individual sleep promotion plan (ISPP) that included

• Sleep hygiene
• Relaxation prescription
• Stimulus control
• Sleep restriction delivered by a registered nurse (RN).

The ISPP started two days before the first prescription; continued during chemotherapy prescription; was revised 30, 60, and 90 days after the last prescription; and was reinforced seven days later. There were three doses and reinforcements.

• Twenty-one Caucasian patients (100% female) were included. 
• Mean age was 55.3 years (range 43–66).
• Patients had stage I or II breast cancer following adjuvant chemotherapy.

• Midwestern United States
• Patient homes 

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

This was a prospective, repeated measures, feasibility study with a single group and no control.

• Piper Fatigue Scale (PFS) and single fatigue intensity item
• Piper’s Integrated Fatigue Model (IFM)
• Adherence
• Sleep

Adherence to the intervention was high except for stimulus control. Fatigue scores were not significantly different over time.

• The pilot study was not designed to test the effectiveness of the intervention.
• The study had a small sample size.
• Research RN training was needed.
• The actigraph had costs.

Patients received multicomponent cognitive-behavioral therapy (CBT). Individual sleep promotion plans (ISPPs) included

• Sleep hygiene 
• Relaxation prescription
• Stimulus control
• Sleep restriction delivered by a registered nurse (RN). 

Each plan started two days before the first prescription, was revised before each prescription, and was and reinforced seven days after each prescription. There were four doses and reinforcements.

• Twenty-five Caucasian patients (100% female) were included.
• Mean age was 54.3 years (range 40–65).
• Patients had stage I or II breast cancer and were receiving adjuvant chemotherapy.

• Midwestern United States
• Urban oncology clinics
• Patient homes

Patients were undergoing the active treatment phase of care.

This was a prospective, repeated measures, feasibility study with a single group and no control.

• Piper’s Integrated Fatigue Model (IFM)
• Piper Fatigue Scale (PFS) and single fatigue intensity item
• Adherence
• Sleep

• There was moderate to high adherence (46%–80%) to the components of the sleep plan.
• Fatigue on the PFS two days postchemotherapy was stable over time.
• Fatigue intensity was lower (not significant) postchemotherapy three but rebounded after chemotherapy four.

• The pilot study was not designed to test the effectiveness of the intervention.
• The study had a small sample size.
• Research RN training was needed.
• The actigraphs had costs.

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.

Participants received multimodal cognitive-behavioral group therapy in six 1- to 1.5-hour sessions, given weekly x5 and then repeated in four weeks. Therapy included stimulus control therapy, relaxation training, sleep consolidation strategies, and strategies to reduce cognitive-emotional arousal.

• Fourteen patients, including 11 women, were included, and 12 completed the study.
• Mean age was 54.7 years. 
• Median time from diagnosis was 33.6 months.

Outpatient clinics at Major Cancer Center in Central Canada and the community serving the Cancer Center, Midwestern Canada

This was a repeated measure, single-group design with no control group.

• Fatigue subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Sleep
• Anxiety
• Depression

Fatigue significantly decreased at week eight in comparison to baseline. Values of sleep, mood, and functioning improved from baseline, to four weeks, and to eight weeks after the intervention. Improved sleep measures included

• Number of awakenings
• Wake after sleep onset
• Sleep efficiency
• Sleep Impairment Index.

• The study had a small sample size.
• Participants were relatively healthy.
• Only self-reports were used.
• There was no placebo control group.
• The duration of the effects after eight weeks is unknown.
• Space to provide intervention.

The intervention was delivered by a master’s prepared nurse and consisted of four weekly classes and two weeks of treatment conducted through individual weekly telephone sessions. Each class followed a standard format using a treatment manual. The cognitive-behavioral therapy (CBT) intervention consisted of stimulus control instructions, sleep restriction therapy, sleep education, and hygiene content, including cognitive strategies. The aim of the stimulus control interventions was to shape cognitions to reassociate the bed and bedroom with rapidly falling asleep or falling back to sleep. The aims of stimulus control were to acquire a consistent sleep pattern, strengthen the bed and bedroom as cues for sleep, and weaken them as cues for activities that interfere with sleep. Sleep restriction therapy was based on the observation that people with insomnia spend too much time in bed attempting to sleep. The treatment focused on developing a sleep-wake schedule that consolidates sleep and limits it to a specific time by restricting the amount of time spent in bed. Sleep education and hygiene consisted of giving basic information about sleep processes and functions, developmental sleep changes, circadian rhythms, individual sleep needs, sleep deprivation, and supportive information. Dysfunctional cognitions that may contribute to sleep difficulty were also challenged.

• Seventy-two women with breast cancer were included.
• Mean age was 58 years. 
• Patients were at least three months postcompletion of primary treatment and without current evidence of disease.
• Patients were predominantly Caucasian (96%) and married (68%).
• Of the patients, 68% were either retired or employed full-time.
• Most patients had stage I (50%) or II (29%) disease at diagnosis.
• The exclusion criteria included cognitive impairment as determined by Mini-Mental State Examination and/or suspicion of sleep apnea, restless leg syndrome, or periodic limb movement disorder.

• Large university in the southwestern United States
• Women were recruited primarily from newspaper advertising, doctor referral, and breast cancer support groups.

This was a randomized, controlled trial with assignment to either CBT for insomnia or a control group that received education about sleep and sleep hygiene.

Profile of Mood States Fatigue/Inertia Subscale (POMS-F/I)

Women in the intervention group demonstrated significantly lower fatigue compared to those in the control group. The authors concluded that because mediation analyses indicated that the intervention had no direct effect on any of the psychosocial outcomes, that the intervention had an indirect effect on the outcome of fatigue due in part to improvements in sleep quality (both groups demonstrated improvements in mean scores for insomnia severity across the course of the study, and in a study reported elsewhere, they also demonstrated significant improvements in other sleep outcome indicators and favorable changes in actigraphy).

• Outcomes were evaluated immediately following the intervention; therefore, the long-term sustainability of the intervention effects is not known.
• It was difficult to isolate the components of the intervention that produced improvement because both the intervention and the control group received psychological and peer group and individual support, as well as the sleep education and hygiene component of the CBT intervention.

A modest amount of continuing education, as well as access to some instructional materials for patients, are needed to prepare health care professionals to deliver CBT interventions for insomnia.

Nurses administered a cognitive-behavioral therapy (CBT) intervention consisting of five weekly 50-minute sessions provided during early afternoon or early evening. The intervention included standard CBT components, such as stimulus control, sleep restriction, and cognitive therapy strategies. The nurses had participated in CBT courses and psychologist-supervised practice and had audiotapes from randomly selected sessions evaluated for congruence with intervention components and principles.

Participants were randomized to either receive CBT or treatment as usual, with stratification for center, prerandomization Pittsburgh Sleep Quality Index (PSQI) scores, existing treatment for insomnia, and tumor type. A 2:1 treatment allocation, in favor of the intervention, was selected to make efficient use of the available CBT sessions and minimize the time patients would have to wait for CBT, thus reducing the potential for patient dropout. Researchers used several strategies to promote intervention fidelity and the integrity of the treatment allocations:  the study staff did not interact with other patients in the treatment as usual group, clinicians working with participants in the treatment as usual group did not receive any information about CBT; and printed intervention materials were developed.

• Participants were recruited by mail, posters, and directly by clinic staff.
• Participants were drawn from the outpatient clinics at one of two large oncology centers in Great Britain.
• Of the 150 participants, 103 were female and 47 were male.
• Mean age was 61 years (range 38–86).
• Less than 40% of participants were employed.
• Median interval between cancer diagnosis and the presentation of insomnia complaint to the research team was longer than two years.
• All participants had insomnia longer than six months, with a group median of 30 months.
• Twenty-five percent of participants had insomnia longer than five years.
• Twenty-three percent of the sample took a hypnotic medication for one or more night of the 10-night baseline.
• Participants had breast, prostate, bowel, or gynecological cancer and satisfied the diagnostic criteria for chronic insomnia (defined as a mean value longer than 30 minutes for complaint of delayed sleep-onset latency and/or wake time after sleep onset, occurring three or more nights per week for three or more months and affecting daytime function).
• Participants also had to screen greater than five on the PSQI, a psychometrically robust instrument that identifies clinically significant sleep disturbance.
• Treatment (radiation therapy or chemotherapy) had to be completed by one month or more with no further anticancer therapy planned (excepting adjuvant hormone therapy).
• Participants with acute illness, an estimated prognosis less than six months, confusional problems, drug misuse, evidence of other sleep disorders (e.g., sleep apnea), or with untreated psychiatric disorders were excluded.

This was a randomized, controlled, pragmatic, two-center trial of CBT.

Fatigue Symptom Inventory Interference Subscale

Compared with usual care, CBT resulted in a statistically significant improvement in fatigue interference/daytime fatigue following CBT treatment, and these improvements were sustained at six-month follow-up. Two-thirds of CBT participants attended all therapy sessions, and 94% attended at least three of five CBT sessions. There were similar levels of attrition in the intervention (18%) and usual-care comparison (16%) groups.

Neither interventionists nor patients were blinded to study group allocation, and participants' knowledge that they were assigned to particular treatment arms may have influenced their responses on patient-reported outcome measures.

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 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 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.

To examine the effect of cognitive-behavioral therapy (CBT) on fatigue and to examine whether the effect on fatigue is mediated by physical activity and/or physical fitness.

Patients referred for CBT were randomly assigned to the intervention group or to a wait-list control group. The CBT intervention was provided in six modules focusing on coping, rear of disease recurrence, dysfunctional cognitions related to fatigue, activity management, dysregulation of sleep, social support, and negative social interactions. Material was adapted to the individual patients. All patients set a baseline level of physical activity and, once set, began an activity program of cycling or walking five to 10 minutes twice daily. This was increased to a maximum of 120 minutes daily. Study measures were obtained at baseline and six-month follow-up. Physical activity was measured for two weeks prior to study entry.

• Thirty-seven patients (48.6% male and 51.4% female) were included.            
• Mean age was 49.5 years.
• Patients had various disease types of solid tumors or non-Hodgkin lymphoma.  
• All patients had completed initial antitumor therapy. 
• At baseline, average time since diagnosis was 52 months for the intervention group and 45 months for the control group.
• Patients with psychological problems or treatment and those with depression were excluded.

• Single site  
• Setting not specified    
• Netherlands

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

This was a randomized, controlled trial.

• Checklist Individual Strength (CIS) fatigue severity subscale
• Sickness Impact Profile (SIP)
• Actigraphy:  resting and activity oxygen consumption, ventilation, respiratory quotient, and maximal oxygen consumption

Forty-six percent of patients in the intervention were lost to follow-up. The CBT group had a significantly greater improvement in fatigue scores than control patients (p < 0.001). There was significantly greater improvement in functional impairment in the CBT group compared to controls (p = 0.009). Fatigue and impairment improved over the six-month period in both groups. There were no significant differences between groups in physical activity or physical fitness measures at baseline or follow-up. Analysis showed no mediation effect of physical activity or physical fitness.

Findings suggested that CBT was effective in reducting cancer-related fatigue and sickness impact scores. Findings suggested that this effect was not mediated by physical activity or fitness.

• The study had a small sample size, with less than 100 patients.
• Baseline sample/group differences were of import. 
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• Unintended interventions or applicable interventions that would influence the results were not described.
• Key sample group differences could influence the results.
• Measurement validity/reliability was questionable.
• Patient withdrawals were 10% or greater.
• Physical activity was only measured at baseline, and activity levels in both groups over the course of the study period were not measured and reported. This suggests that findings regarding the potential mediation of CBT effects by activity were not valid. 
• More patients in the control group had a combination of surgery, chemotherapy, and radiation therapy, which may have had a greater impact on fatigue. 
• The large drop-out rate in the intervention group was a limitation of findings. 
• There was no analysis of differences between those who were lost to follow-up and others.

Findings supported the potential effectiveness of CBT for fatigue management in cancer care. These findings were in patients about four years after completion of treatment, suggesting benefits even long after active treatment. There were several study limitations that reduced the strength of this evidence.

Patients received multimodal cognitive-behavioral therapy (CBT) that combined cognitive, behavioral, and educational strategies. Treatment consisted of eight weekly sessions administered in a group of five participants combined with use of stimulus control, sleep restriction, cognitive therapy, sleep hygiene, and fatigue and stress management. The treatment protocol was based on clinical procedures developed by Morin (1993) and adapted by the investigators for the cancer population.

Ten breast cancer survivors participated in this pilot study. 

Patients were included in the study if they

• Completed radiotherapy of chemotherapy for a stage I to III breast cancer at least one month prior to enrollment
• Met the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) diagnostic criteria for a chronic insomnia syndrome.

Patients who regularly used psychotropic medications other than hypnotics were excluded unless the dosage use was stable in the last month and did not increase during the study.  Individuals currently receiving psychotherapy were also excluded.

• Cancer research facility
• Participants were recruited via fliers and pamphlets.

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

This was a single-arm study with no control group.

Multidimensional Fatigue Inventory (MFI)

Nonparametric statistical testing revealed significant improvements in the general and physical subscales of the MFI; there was no significant change between pre- and posttreatment on the mental, activities, and motivation subscales of the MFI. There was no significant change observed from posttreatment through six-month follow-up on the MFI general and physical subscales, suggesting that the treatment gains were sustained over time.

• The study had a small sample size.
• The effect could have potentially occurred as a result of group support rather than the CBT intervention itself.
• Sustained improvements in fatigue may also be a result of a maturation effect wherein fatigue declined as might be expected, with greater distance from treatment.
• Trained personnel were needed to administer the CBT intervention.
• Group treatment had costs.

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.

The cognitive-behavioral therapy (CBT) intervention for insomnia consisted of eight weekly sessions of approximately 90 minutes, offered in groups of four to six patients, and delivered by a clinical psychologist. The treatment protocol was multimodal and combined behavioral (e.g., stimulus control therapy, sleep restriction), cognitive (i.e., cognitive restructuring), and educational (i.e., sleep hygiene, fatigue and stress management) strategies that were described in a treatment manual given to all participants. A booster session was offered to participants one month after the end of treatment. Missed treatment sessions were rescheduled; therefore, all patients received the entire treatment program. Outcomes were evaluated at the conclusion of the intervention, as well as at three, six, and 12 months after the end of treatment.

Fifty-seven women with stage I to III breast cancer who met the diagnostic criteria for a chronic insomnia syndrome (CBT group, n=27; comparison group, n=30) were included.

Diagnostic criteria included

• Difficulty initiating and/or maintaining sleep, whereby sleep-onset latency and/or wake after sleep onset is greater than 30 minutes
• Sleep efficiency (ratio of total sleep time to total time spent in bed) was lower than 85%
• Difficulties occurring for at least six months
• Difficulties causing marked distress or significant impairment in daytime functioning (e.g., fatigue, disturbed mood, performance deficits).

Only patients whose insomnia was judged to be secondary to cancer were included in the study (i.e., those whose sleep difficulties were caused or aggravated by the cancer diagnosis or treatment).  Most of the sample had received prior adjuvant treatment with radiation therapy (85.2%), chemotherapy (37%), or hormone therapy (59.3%).  Slightly more than one-third of the sample was currently receiving hormone therapy (37%).

Exclusion criteria included severe major depression or other serious psychiatric disorder; presence of a sleep disorder other than insomnia (e.g., sleep apnea), presence of another illness affecting the immune system (e.g., human immunodeficiency virus [HIV] infection), and regular use of a psychotropic medication other than hypnotics (e.g., antidepressants) unless the dosage used was stable in the last month and did not increase during the study; and current involvement in psychotherapy.

• Outpatient
• Large academic medical center
• Participants were recruited through flyers and pamphlets, ads placed in local newspapers, and physician referrals.

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial, with patients randomly assigned to CBT for insomnia or a wait-list control group.

Multidimensional Fatigue Inventory (MFI)

Analysis of pooled data revealed a statistically significant improvement in fatigue from pre- to posttreatment, with maintenance of this improvement during the 12-month follow-up period.

• The fact that the study sample was primarily Caucasian and well educated and all patients were survivors of breast cancer may limit the generalization of the findings.
• The use of a wait-list control condition did not allow for the control of nonspecific therapeutic elements in the intervention, such as therapist empathy, group support, etc.
• A modest amount of continuing education, as well as access to some instructional materials for patients, are needed to prepare health care professionals to deliver CBT interventions for insomnia.

Patients received multimodal cognitive-behavioral therapy (CBT) that combined cognitive, behavioral, and educational strategies. Treatment consisted of eight weekly sessions administered in a group of four to six participants and was combined with use of stimulus control, sleep restriction, cognitive therapy, sleep hygiene, and fatigue and stress management. The treatment protocol was based on clinical procedures developed by Morin (1993) and was adapted by the investigators for the cancer population.

Fifty-seven breast cancer survivors were randomly assigned to a CBT (n=27) or waiting list condition (n=30).

Patients were included in the study if they

• Had completed radiotherapy of chemotherapy for a stage I to III breast cancer at least one month prior to enrollment
• Met the Diagnostic and Statistical Manual of Mental Disorders-Fourth Editoin (DSM-IV) diagnostic criteria for a chronic insomnia syndrome.

Patients who regularly used psychotropic medications other than hypnotics (e.g., antidepressants) were excluded unless the dosage use was stable in the last month and did not increase during the study. Individuals currently receiving psychotherapy were also excluded.

• Cancer research facility
• Participants were recruited via fliers and pamphlets, advertisements placed in local newspapers, and physician referrals.

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

This was a randomized, controlled trial with a waiting list control group and a 12-month follow-up period to assess the short- and long-term effects of the intervention.

Multidimensional Fatigue Inventory (MFI)-French Canadian version to measure fatigue

Pooled analyses within an intent-to-treat framework revealed significant differences between pre- and posttreatment on fatigue (p < 0.001). No significant difference was detected between posttreatment and the three-, six-, and 12-month evaluations of fatigue, suggesting that the clinical improvement relative to the outcome of fatigue was durable.

• Participants were primarily Caucasian and well educated.
• Of the patients, 36% who were interested in the study and had responded to the advertisement screened out or declined to participate once they heard more about the study. This may limit the generalization of the findings.
• Reasons for exclusion included severe psychiatric disorder, not meeting the DSM-IV diagnostic criteria for chronic insomnia, or having insomnia that was not judged to be secondary to cancer (some participants were also screened out due to ongoing cancer treatment).
• Approximately 20% of the individuals judged the study to be too burdensome when they learned the treatment details and declined to be enrolled.
• Use of the waiting list control condition did not allow for the control of nonspecific therapeutic ingredients.
• Trained personnel were needed to administer the CBT intervention.
• Group treatment had costs.

It is not possible to determine whether the improvements in fatigue observed in this study are attributable to the CBT strategies or to other ingredients common to all psychotherapeutic approaches (e.g., therapist empathy, group support). Sustained improvements in fatigue may also be a result of a maturation effect wherein fatigue declined as might be expected, with greater distance from treatment.

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.

PHASE OF CARE: Late effects and survivorship

Adapted from three guidelines by multidisciplinary experts using supplementary evidence and clinical experience. Most recommendations listed verbatim but some modified to include updated evidence or current practice beliefs.

Recommendations focused on patients who have completed active treatment or are considered in clinical remission. Treat underlying causes, moderate physical activity after cancer treatment with PT and lymphedema referrals as needed (meta-analysis, systematic review, [randomized controlled trial [RCT]; 10 cited), cognitive behavioral therapy (meta-analysis, RCT, systematic reviews; 6 cited), psychoeducational therapies (systematic, RCT; 3 cited), psychosocial services, mindfulness-based interventions (RCT; 3 cited), yoga (RCT; 2 cited), acupuncture (RCT; 2 cited), psychostimulants/wakefulness agents (limited evidence in patients who are post-treatment disease-free). Additional areas in which research needed include biofield therapies, massage, music therapy, relaxation, Reiki, Qigong, ginseng, and vitamin D.

Guidelines were tailored to survivors with current evidence as not all evidence done is survivors.

Screening, assessment, and treatment guidelines summarized for use in cancer survivors.

PHASE OF CARE: Multiple phases of care

Two hundred two references were retrieved. The total number of references included and reviewed for updating was not provided. No quality rating is identified.

• Energy conservation
• Physical activity
• Cognitive behavioral therapy (CBT) for sleep shown to be effective
• Counseling

• Limited evidence search
• No quality rating of studies considered
• Studies included for evidence level determination not specified

The guidelines provide suggestions for screening and identify some tools for fatigue assessment and some key interventions for the management of fatigue. They provide an overview of relevant evidence for multiple types of interventions. Major suggestions are identified in the recommendations section of this summary.