M.F.M. Gielissen

Effects of Cognitive Behavior Therapy in Severely Fatigued Disease-Free Cancer Patients Compared With Patients Waiting for Cognitive Behavior Therapy: A Randomized Controlled Trial

PURPOSE Persistent fatigue is a long-term adverse effect experienced by 30% to 40% of patients cured of cancer. The main objective of this randomized controlled trial was to show the effectiveness of cognitive behavior therapy (CBT) especially designed for fatigue in cancer survivors. PATIENTS AND METHODS A total of 112 cancer survivors with somatically unexplained fatigue were allocated randomly to immediate cognitive behavior therapy or to a waiting list condition for therapy. Both conditions were assessed two times, at baseline and 6 months later. The primary outcome variables were fatigue severity (Checklist Individual Strength) and functional impairment (Sickness Impact Profile). Data were analyzed by intention to treat. RESULTS Analyses were based on 50 patients in the intervention condition and 48 patients in the waiting list condition. Patients in the intervention condition reported a significantly greater decrease than patients in the waiting list condition in fatigue severity (difference, 13.3; 95% CI, 8.6 to 18.1) and in functional impairment (difference, 383.2; 95% CI, 197.1 to 569.2). Clinically significant improvement for the CBT group compared with the waiting list group was seen in fatigue severity (54% v 4% of the patients, respectively) and in functional impairment (50% v 18% of the patients, respectively). CONCLUSION Cognitive behavior therapy has a clinically relevant effect in reducing fatigue and functional impairments in cancer survivors.

Is a full recovery possible after cognitive behavioural therapy for chronic fatigue syndrome

Background: Cognitive behavioural therapy (CBT) for chronic fatigue syndrome (CFS) leads to a decrease in symptoms and disabilities. There is controversy about the nature of the change following treatment; some suggest that patients improve by learning to adapt to a chronic condition, others think that recovery is possible. The objective of this study was to find out whether recovery from CFS is possible after CBT. Methods: The outcome of a cohort of 96 patients treated for CFS with CBT was studied. The definition of recovery was based on the absence of the criteria for CFS set up by the Center for Disease Control (CDC), but also took into account the perception of the patients’ fatigue and their own health. Data from healthy population norms were used in calculating conservative thresholds for recovery. Results: After treatment, 69% of the patients no longer met the CDC criteria for CFS. The percentage of recovered patients depended on the criteria used for recovery. Using the most comprehensive definition of recovery, 23% of the patients fully recovered. Fewer patients with a co-morbid medical condition recovered. Conclusion: Significant improvement following CBT is probable and a full recovery is possible. Sharing this information with patients can raise the expectations of the treatment, which may enhance outcomes without raising false hopes.

Cognitive behaviour therapy for fatigued cancer survivors: long-term follow-up

An earlier randomised-controlled trial demonstrated the positive effects of cognitive behaviour therapy (CBT), especially designed for fatigued cancer survivors in reducing fatigue, functional impairments and psychological distress. In the current prospective study, we were able to examine the long-term effect of CBT in patients who completed the therapy. Predictors of fatigue severity at follow-up were exploratory investigated. Sixty-eight patients who completed CBT were assessed at pretreatment, post-treatment and at follow-up (mean follow-up 1.9 years (s.d. 1.0), range: 1–4 years). To analyse possible predictors of treatment outcome a linear regression (enter) was carried out. Improvements on fatigue severity, functional impairment and psychological distress after CBT appeared to remain stable during a follow-up period. Patients who were not fatigued anymore at follow-up were not different from a reference group of non-fatigued cancer survivors. The explorative regression analysis showed that fatigue severity, psychological distress and somatic attributions at pretreatment contributed to persistent fatigue severity at follow-up. Cognitive behaviour therapy, especially designed for post-cancer fatigue, is successful in reducing fatigue and functional impairment in cancer survivors. Moreover, these positive effects were maintained at about 2 years after finishing CBT.

The Cancer Worry Scale: detecting fear of recurrence in breast cancer survivors.

Background: In 9% to 34% of cancer patients, the fear of cancer recurrence becomes so overwhelming that it affects quality of life. Clinicians need a brief questionnaire with a cutoff point that is able to differentiate between high- and low-fearful survivors. Objective: This study investigated if the Cancer Worry Scale (CWS) could serve as an instrument to detect high levels of fear of recurrence in female breast cancer survivors. Methods: One hundred ninety-four female breast cancer patients were assessed up to 11 years after their primary treatment for cancer. The women returned the questionnaires including the 8-item CWS, 2 items of the Cancer Acceptance Scale, the Checklist Individual Strength-Fatigue subscale, and the Cancer Empowerment Questionnaire. Results: A cutoff score of 13 versus 14 (low: ⩽13, high: ≥14) on the CWS was optimal for detecting severe levels of fear of recurrence. A cutoff score of 11 versus 12 (low: ⩽11, high: ≥12) was optimal for screening. The Cronbach &agr; coefficient of the CWS was .87; evidence to support the convergent and divergent validity of the CWS was also obtained. The CWS is able to detect high levels of fear of recurrence. Conclusion: The CWS is a reliable and valid questionnaire to assess fear of recurrence in breast cancer survivors. Implications for Practice: With the CWS, it is possible for nurses to screen breast cancer survivors for severe levels of fear of cancer recurrence. Thereby, nurses can screen and assist survivors in accessing appropriate and available support.

Experience of severe fatigue in long-term survivors of stem cell transplantation

The literature suggests that cancer survivors with more aggressive treatments are more at risk for postcancer fatigue. In this study, we investigated the prevalence of fatigue after completion of stem cell transplantation (SCT). Furthermore, we studied if medical variables are associated with fatigue and if the model of perpetuating factors of postcancer fatigue derived from previous studies in cancer survivors, without SCT, is applicable in SCT survivors. Ninety-eight patients treated with autologous or allogeneic SCT filled out several questionnaires. Medical characteristics were obtained from the medical charts. All patients had to be in persistent complete remission for at least 1 year. Thirty-five per cent of the patients experienced severe fatigue. The percentage of patients with severe fatigue remained stable during the years after transplantation. Several psychosocial factors, but no medical factors, were associated with fatigue. The model of perpetuating factors appeared to be applicable. Contrary to cancer survivors without SCT, we found no decrease in fatigue complaints during the first years after SCT. Cognitive behaviour therapy (CBT) is a general form of psychotherapy directed at changing condition-related cognitions and behaviours. CBT especially designed for postcancer fatigue, aimed at perpetuating factors, can also be used to manage fatigue in cancer survivors treated with SCT.

Is Increasing Physical Activity Necessary to Diminish Fatigue During Cancer Treatment? Comparing Cognitive Behavior Therapy and a Brief Nursing Intervention with Usual Care in a Multicenter Randomized Controlled Trial

BACKGROUND Two interventions for fatigue were given during curative cancer treatment. The aim of this multicenter randomized controlled trial (RCT) with three conditions was to demonstrate the efficacy and to determine the contribution of physical activity. METHODS Recruited from seven hospitals, 220 patients with various malignancies participated in a RCT. The brief nursing intervention (BNI) consisted of two 1-hour sessions, 3 months apart, given by 12 trained nurses, focusing only on physical activity. Cognitive behavior therapy (CBT) consisted of up to ten 1-hour sessions, within 6 months, provided by two therapists, focusing on physical activity and psychosocial elements. The control group received only usual care (UC). Assessments took place before and at least 2 months after cancer treatment, when patients had recovered from acute fatigue. Fatigue was the primary outcome. Efficacy was tested using analyses of covariance. A nonparametric bootstrap approach was used to test whether the effect on fatigue was mediated by physical activity. RESULTS The CBT group was significantly less fatigued than the UC group. Between the BNI and the UC groups, no significant difference was found in fatigue. The mediation hypothesis was rejected. DISCUSSION CBT given during curative cancer treatment proved to be an effective intervention to reduce fatigue at least 2 months after cancer treatment. The BNI was not effective. Contrary to what was expected, physical activity did not mediate the effect of CBT on fatigue. Thus, the reduction in fatigue elicited by CBT was realized without a lasting increase in physical activity.

Development of Fatigue in Cancer Survivors: A Prospective Follow-Up Study From Diagnosis Into the Year After Treatment

CONTEXT There is a lack of longitudinal studies investigating fatigue from before cancer treatment to long after successful cancer treatment. OBJECTIVES This prospective follow-up study aimed to determine the prevalence and predictors of persistent fatigue in cancer survivors in the first year after completion of cancer treatment. METHODS Sixty patients with various malignancies were assessed before (T1), shortly after curative cancer treatment (T2), and one year after T2 (T3). Fatigue was assessed monthly between T2 and T3. Fatigue severity was measured using the subscale of the Checklist Individual Strength. Questionnaires were used to measure impaired sleep and rest, physical activity, social support, fatigue catastrophizing, and somatic-related attributions regarding fatigue. Linear regression analyses were performed to identify predictors of persistent fatigue. RESULTS In total, 22% of survivors had severe persistent fatigue over the last six months in the first year after cancer treatment. Fatigue at T1, T2, and negative interactions predicted the severity of persistent fatigue. Analyses without fatigue showed that more negative interactions, impaired sleep and rest, fatigue catastrophizing, and lower self-reported physical activity at T2 were associated with the severity of persistent fatigue. CONCLUSION Twenty-two percent of the survivors had severe persistent fatigue in the year after cancer treatment. Fatigue and cognitive behavioral factors predicted persistent fatigue in the year after cancer treatment. Diagnosis or cancer treatment did not predict persistent fatigue. The implication is that cognitive behavioral therapy for postcancer fatigue, aimed at the fatigue-perpetuating factors, could be offered from two months after successful cancer treatment.

BREATH: Web-Based Self-Management for Psychological Adjustment After Primary Breast Cancer—Results of a Multicenter Randomized Controlled Trial

PURPOSE Early breast cancer survivors (BCSs) report high unmet care needs, and easily accessible care is not routinely available for this growing population. The Breast Cancer E-Health (BREATH) trial is a Web-based self-management intervention to support the psychological adjustment of women after primary treatment, by reducing distress and improving empowerment. PATIENTS AND METHODS This multicenter, randomized, controlled, parallel-group trial evaluated whether care as usual (CAU) plus BREATH is superior to CAU alone. BREATH is delivered in sixteen fully automated weekly modules covering early survivorship issues. Two to 4 months post-treatment, BCSs were randomly assigned to receive CAU + BREATH (n = 70) or CAU alone (n = 80) using a stratified block design (ratio 1:1). Primary outcomes were distress (Symptom Checklist-90) and empowerment (Cancer Empowerment Questionnaire), assessed before random assignment (baseline, T0) and after 4 (T1), 6 (T2), and 10 months (T3) of follow-up. Statistical (analysis of covariance) and clinical effects (reliable change index) were tested in an intention-to-treat analysis (T0 to T1). Follow-up effects (T0 to T3) were assessed in assessment completers. RESULTS CAU + BREATH participants reported significantly less distress than CAU-alone participants (-7.79; 95% CI, -14.31 to -1.27; P = .02) with a small-to-medium effect size (d = 0.33), but empowerment was not affected (-1.71; 95% CI, 5.20 to -1.79; P = .34). More CAU + BREATH participants (39 of 70 [56%]; 95% CI, 44.1 to 66.8) than CAU-alone participants (32 of 80 [40%]; 95% CI, 30.0 to 51.0) showed clinically significant improvement (P = .03). This clinical effect was most prominent in low-distress BCSs. Secondary outcomes confirmed primary outcomes. There were no between-group differences in primary outcomes during follow-up. CONCLUSION Access to BREATH reduced distress among BCSs, but this effect was not sustained during follow-up.

Risk factors, prevalence, and course of severe fatigue after breast cancer treatment: a meta-analysis involving 12 327 breast cancer survivors

BACKGROUND This meta-analysis aimed to (i) examine demographic, disease-related, and treatment-related risk factors, (ii) estimate the prevalence, and (iii) describe the course of severe fatigue following breast cancer (BC) treatment. METHODS PubMed, PsycINFO, Cochrane, CINAHL, and Web of Science were systematically searched from inception up to 23 November 2015. Risk factors and prevalence rates were analyzed with inverse variance random-effects analyses. Heterogeneity was studied with sensitivity analyses. RESULTS Twenty-seven studies were included (N = 12 327). Breast cancer survivors (BCS) with a partner were at lower risk for severe fatigue than survivors without a partner [risk ratio (RR) 0.96, 95% confidence interval (CI) 0.93-0.98]. Survivors with stage II or III cancer, and survivors treated with chemotherapy were at higher risk for severe fatigue than survivors with stage 0 or I cancer and without chemotherapy (RR respectively 1.18, 95% CI 1.08-1.28; 1.12, 95% CI 1.06-1.19). Survivors treated with surgery, radiotherapy, and chemotherapy, and survivors with this combination plus hormone therapy were at higher risk than survivors with other treatment combinations (RR respectively 1.18, 95% CI 1.05-1.33; 1.38, 95% CI 1.15-1.66). Survivors treated with surgery and surgery plus radiotherapy were at lower risk than survivors with additional treatments (RR respectively 0.83, 95% CI 0.70-0.98; 0.87, 95% CI 0.78-0.96). Hormone and targeted therapy were no significant risk factors. The pooled prevalence of severe fatigue was 26.9% (95% CI 23.2-31.0), but this should be interpreted with caution because of high heterogeneity. A relatively large decrease in the prevalence of severe fatigue seemed to occur in the first half year after treatment completion. CONCLUSIONS Approximately one in four BCS suffer from severe fatigue. Risk factors of severe fatigue were higher disease stages, chemotherapy and receiving the combination of surgery, radiotherapy, and chemotherapy, both with and without hormone therapy. Having a partner, receiving only surgery, and surgery plus radiotherapy decreased the risk.

Efficacy of Blended Cognitive Behavior Therapy for High Fear of Recurrence in Breast, Prostate, and Colorectal Cancer Survivors: The SWORD Study, a Randomized Controlled Trial

Purpose Fear of cancer recurrence (FCR) is a common problem experienced by cancer survivors. Approximately one third of survivors report high FCR. This study aimed to evaluate whether blended cognitive behavior therapy (bCBT) can reduce the severity of FCR in cancer survivors curatively treated for breast, prostate, or colorectal cancer. Patients and Methods This randomized controlled trial included 88 cancer survivors with high FCR (Cancer Worry Scale score ≥ 14) from 6 months to 5 years after cancer treatment. Participants were randomly allocated (ratio 1:1, stratified by cancer type) to receive bCBT, including five face-to face and three online sessions (n = 45) or care as usual (CAU; n = 43). Participants completed questionnaires at baseline (T0) and 3 months later (T1). The intervention group completed bCBT between T0 and T1. The primary outcome was FCR severity assessed with the Cancer Worry Scale. Secondary outcomes included other distress-related measures. Statistical (one-way between-group analyses of covariance) and clinical effects (clinically significant improvement) were analyzed by intention to treat. Results Participants who received bCBT reported significantly less FCR than those who received CAU (mean difference, -3.48; 95% CI, -4.69 to -2.28; P < .001) with a moderate-to-large effect size ( d = 0.76). Clinically significant improvement in FCR was significantly higher in the bCBT group than in the CAU group (13 [29%] of 45 compared with 0 [0%] of 43; P < .001); self-rated improvement was also higher in the bCBT group (30 [71%] of 42 compared with 12 [32%] of 38 in the CAU group; P < .001). Conclusion bCBT has a statistically and clinically significant effect on the severity of FCR in cancer survivors and is a promising new treatment approach.