Moderators of the effect of psychosocial interventions on fatigue in women with breast cancer and men with prostate cancer: Individual patient data meta-analyses.

OBJECTIVE: Psychosocial interventions can reduce cancer-related fatigue effectively. However, it is still unclear if intervention effects differ across subgroups of patients. These meta-analyses aimed at evaluating moderator effects of (a) sociodemographic characteristics, (b) clinical characteristics, (c) baseline levels of fatigue and other symptoms, and (d) intervention-related characteristics on the effect of psychosocial interventions on cancer-related fatigue in patients with non-metastatic breast and prostate cancer. METHODS: Data were retrieved from the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) consortium. Potential moderators were studied with meta-analyses of pooled individual patient data from 14 randomized controlled trials through linear mixed-effects models with interaction tests. The analyses were conducted separately in patients with breast (n = 1091) and prostate cancer (n = 1008). RESULTS: Statistically significant, small overall effects of psychosocial interventions on fatigue were found (breast cancer: ß = -0.19 [95% confidence interval (95%CI) = -0.30; -0.08]; prostate cancer: ß = -0.11 [95%CI = -0.21; -0.00]). In both patient groups, intervention effects did not differ significantly by sociodemographic or clinical characteristics, nor by baseline levels of fatigue or pain. For intervention-related moderators (only tested among women with breast cancer), statistically significant larger effects were found for cognitive behavioral therapy as intervention strategy (ß = -0.27 [95%CI = -0.40; -0.15]), fatigue-specific interventions (ß = -0.48 [95%CI = -0.79; -0.18]), and interventions that only targeted patients with clinically relevant fatigue (ß = -0.85 [95%CI = -1.40; -0.30]). CONCLUSIONS: Our findings did not provide evidence that any selected demographic or clinical characteristic, or baseline levels of fatigue or pain, moderated effects of psychosocial interventions on fatigue. A specific focus on decreasing fatigue seems beneficial for patients with breast cancer with clinically relevant fatigue.

The efficacy of Internet-based cognitive behavioral therapy for severely fatigued survivors of breast cancer compared with care as usual: A randomized controlled trial.

BACKGROUND: Severe fatigue is a common and distressing symptom affecting approximately one in four survivors of breast cancer. The current study examined the efficacy of Internet-based cognitive behavioral therapy (ICBT) for severe fatigue in survivors of breast cancer compared with care as usual (CAU). METHODS: The authors conducted a parallel-group randomized controlled trial. Severely fatigued, disease-free survivors of breast cancer who had completed cancer treatment at least 3 months previously were eligible. Participants were randomly allocated to ICBT or CAU using computer-generated stratified block randomization. The primary outcome of fatigue severity was assessed at baseline and after 6 months, as were the secondary outcomes of functional impairment, psychological distress, and quality of life. Statistical effects were tested with analyses of covariance (intention-to-treat analysis). RESULTS: Participants were recruited between January 2014 and March 2016 and assigned to ICBT (66 patients) or CAU (66 patients). Compared with the participants who had received CAU, those who had received ICBT reported lower fatigue scores at 6 months (mean difference [Δ], 11.5; 95% confidence interval [95% CI], 7.7-15.3) and a large effect size (Cohen d = 1.0), with the majority of patients (73%) demonstrating clinically significant improvement. ICBT also was found to lead to lower functional impairment (Δ, 297.8; 95% CI, 145.5-450.1) and psychological distress scores (Δ, 5.7; 95% CI, 3.4-7.9) and higher quality-of-life scores (Δ, 11.7; 95% CI, 5.8-17.7) compared with CAU, with medium to large effect sizes (Cohen d = 0.6-0.8). CONCLUSIONS: ICBT appears to be effective in reducing severe fatigue and related symptoms and meets the current need for easy accessible and more efficient evidence-based treatment options for severely fatigued survivors of breast cancer. Cancer 2017;123:3825-34. © 2017 American Cancer Society.

Fear of cancer recurrence in colorectal cancer survivors.

PURPOSE: Although long-term colorectal cancer (CRC) survivors generally report a good quality of life, fear of cancer recurrence (FCR) remains an important issue. This study investigated whether the Cancer Worry Scale (CWS) can detect high FCR, the prevalence, and characteristics of FCR in CRC survivors. METHODS: Two hundred and eleven patients who had undergone successful CRC surgery in the period 2003-2010 in the Radboud University Medical Center in the Netherlands were asked to participate. All patients were sent an information letter plus questionnaires for collecting information on demographic and medical variables, FCR, distress, and quality of life. RESULTS: Seventy-six patients (36 %; median age of 67.7 years range 41-88 years) completed the questionnaires a median of 5.1 years after surgery. A cut-off score of 14 or higher on the CWS was optimal to detect high FCR. Twenty-nine patients (38 %) experienced high levels of FCR, characterized by higher levels of distress, post-traumatic stress symptoms, and lower quality of life. These individuals particularly reacted to disease-related triggers, felt helpless, were worried, and experienced limitations in daily functioning. High FCR was not associated with demographic or medical variables. CONCLUSION: Long after successful CRC surgery, FCR is a serious problem that impairs the quality of life for a substantial proportion of patients. With the CWS, it is possible to detect high FCR and thereby assist survivors in receiving appropriate care.

Fear of progression in patients with gastrointestinal stromal tumors (GIST): Is extended lifetime related to the Sword of Damocles?

BACKGROUND: Gastrointestinal stromal tumors (GIST) are rare and before 2000, patients had a dismal prognosis with a median survival of less than a year after tumor metastasis. However, the median overall survival has increased to more than five years following the introduction of imatinib and other tyrosine kinase inhibitors (TKI). Little is known about the psychosocial consequences of treatment of GIST, but this is important because patients now are treated and live for longer. This cross-sectional study assessed quality of life, distress, and fear of cancer recurrence or progression in patients with GIST. MATERIAL AND METHODS: Eighty-six patients with localized or metastatic GIST were asked to participate. Patients completed self-report questionnaires including the EORTC-Quality of Life Questionnaire, Hospital Anxiety and Depression Scale, Impact of Event Scale, Cancer Worry Scale, and Fear of Cancer Recurrence Inventory. RESULTS: Fifty-four patients (median age 63.3 years) completed the questionnaires, 33 (61%) of whom were receiving TKI treatment at the time of the study. Overall, the GIST patients had a good global quality of life, but 28 patients had high levels of fear of cancer recurrence/progression. This high level of fear was not related to patient- or treatment-related variables. These patients experienced significantly higher levels of psychological distress, functional impairments, and difficulty making plans for the future than did patients with lower levels of fear. CONCLUSIONS: More attention should be paid to specific cancer-related problems, such as fear of cancer recurrence/progression, in addition to general quality of life issues in patients with GIST.

Distress screening remains important during follow-up after primary breast cancer treatment.

BACKGROUND: To improve psychosocial care, the National Comprehensive Cancer Network recommends the use of the Distress Thermometer (DT) to detect distress among cancer patients. OBJECTIVES: The objectives of this study were to describe the prevalence of distress in breast cancer survivors (BCSs) and to investigate demographic, treatment, and psychosocial variables associated with distress and problems most often reported on the problem list. Moreover, we assessed how many BCSs requested referral to a professional for additional support. METHODS: In a cross-sectional study, 258 BCSs identified at an outpatient clinic of a university hospital were asked to complete the following questionnaires: DT, Quality of Life Questionnaire, Hospital Anxiety and Depression Scale, and Illness Cognition Questionnaire. RESULTS: Of the 258 identified BCSs, 129 (50 %) completed all questionnaires. After a mean follow-up period of 5.6 (SD, 10) years, 47 (36 %) of these 129 BCSs experienced distress as assessed by the DT. BCSs experienced significantly more distress in the first 2 years than in the period between 2 and 5 years after surgery. Also, more distress was experienced in BCSs treated with surgery, radiotherapy, and chemotherapy compared to those treated with surgery only. Problems most frequently encountered were fatigue (57 %), decrease in muscle strength (47 %), and lack of physical fitness (42 %). Thirty one (69 %) of the distressed BCSs requested or considered referral to a professional. Regression analysis showed that reduced quality of life, reduced cognitive function, and fatigue were predictors of distress. CONCLUSION: The current study found that more than one third of all BCSs experienced distress. Screening remains an important part of BCSs' care. The professional should be aware of the potential problems and distress patients may experience.

Usage of a generic web-based self-management intervention for breast cancer survivors: substudy analysis of the BREATH trial.

BACKGROUND: Generic fully automated Web-based self-management interventions are upcoming, for example, for the growing number of breast cancer survivors. It is hypothesized that the use of these interventions is more individualized and that users apply a large amount of self-tailoring. However, technical usage evaluations of these types of interventions are scarce and practical guidelines are lacking. OBJECTIVE: To gain insight into meaningful usage parameters to evaluate the use of generic fully automated Web-based interventions by assessing how breast cancer survivors use a generic self-management website. Final aim is to propose practical recommendations for researchers and information and communication technology (ICT) professionals who aim to design and evaluate the use of similar Web-based interventions. METHODS: The BREAst cancer ehealTH (BREATH) intervention is a generic unguided fully automated website with stepwise weekly access and a fixed 4-month structure containing 104 intervention ingredients (ie, texts, tasks, tests, videos). By monitoring https-server requests, technical usage statistics were recorded for the intervention group of the randomized controlled trial. Observed usage was analyzed by measures of frequency, duration, and activity. Intervention adherence was defined as continuous usage, or the proportion of participants who started using the intervention and continued to log in during all four phases. By comparing observed to minimal intended usage (frequency and activity), different user groups were defined. RESULTS: Usage statistics for 4 months were collected from 70 breast cancer survivors (mean age 50.9 years). Frequency of logins/person ranged from 0 to 45, total duration/person from 0 to 2324 minutes (38.7 hours), and activity from opening none to all intervention ingredients. 31 participants continued logging in to all four phases resulting in an intervention adherence rate of 44.3% (95% CI 33.2-55.9). Nine nonusers (13%), 30 low users (43%), and 31 high users (44%) were defined. Low and high users differed significantly on frequency (P<.001), total duration (P<.001), session duration (P=.009), and activity (P<.001). High users logged in an average of 21 times, had a mean session duration of 33 minutes, and opened on average 91% of all ingredients. Signing the self-help contract (P<.001), reporting usefulness of ingredients (P=.003), overall satisfaction (P=.028), and user friendliness evaluation (P=.003) were higher in high users. User groups did not differ on age, education, and baseline distress. CONCLUSIONS: By reporting the usage of a self-management website for breast cancer survivors, the present study gained first insight into the design of usage evaluations of generic fully automated Web-based interventions. It is recommended to (1) incorporate usage statistics that reflect the amount of self-tailoring applied by users, (2) combine technical usage statistics with self-reported usefulness, and (3) use qualitative measures. Also, (4) a pilot usage evaluation should be a fixed step in the development process of novel Web-based interventions, and (5) it is essential for researchers to gain insight into the rationale of recorded and nonrecorded usage statistics. TRIAL REGISTRATION: Netherlands Trial Register (NTR): 2935; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2935 (Archived by WebCite at http://www.webcitation.org/6IkX1ADEV).

The cancer empowerment questionnaire: psychological empowerment in breast cancer survivors.

New models of cancer care and survivorship ask for empowered patients. But how do we measure that patients can derive strength from themselves (intrapersonal) and their perceived social support (interpersonal)? The 40-item Cancer Empowerment Questionnaire (CEQ) measures psychological empowerment as an individual outcome measure. The CEQ was validated in 140 nonmetastatic female breast cancer survivors (mean 5.5 years postsurgery). Principal component analysis elicited four factors representing intrapersonal (personal strength) and interpersonal (social support, community, health care) aspects of empowerment. The CEQ provides a reliable (Cronbach's α=0.73-0.94) and valid first attempt to operationalize psychological empowerment in cancer care.

Rationale of the BREAst cancer e-healTH [BREATH] multicentre randomised controlled trial: an internet-based self-management intervention to foster adjustment after curative breast cancer by decreasing distress and increasing empowerment.

BACKGROUND: After completion of curative breast cancer treatment, patients go through a transition from patient to survivor. During this re-entry phase, patients are faced with a broad range of re-entry topics, concerning physical and emotional recovery, returning to work and fear of recurrence. Standard and easy-accessible care to facilitate this transition is lacking. In order to facilitate adjustment for all breast cancer patients after primary treatment, the BREATH intervention is aimed at 1) decreasing psychological distress, and 2) increasing empowerment, defined as patients' intra- and interpersonal strengths. METHODS/DESIGN: The non-guided Internet-based self-management intervention is based on cognitive behavioural therapy techniques and covers four phases of recovery after breast cancer (Looking back; Emotional processing; Strengthening; Looking ahead). Each phase of the fully automated intervention has a fixed structure that targets consecutively psychoeducation, problems in everyday life, social environment, and empowerment. Working ingredients include Information (25 scripts), Assignment (48 tasks), Assessment (10 tests) and Video (39 clips extracted from recorded interviews). A non-blinded, multicentre randomised controlled, parallel-group, superiority trial will be conducted to evaluate the effectiveness of the BREATH intervention. In six hospitals in the Netherlands, a consecutive sample of 170 will be recruited of women who completed primary curative treatment for breast cancer within 4 months. Participants will be randomly allocated to receive either usual care or usual care plus access to the online BREATH intervention (1:1). Changes in self-report questionnaires from baseline to 4 (post-intervention), 6 and 10 months will be measured. DISCUSSION: The BREATH intervention provides a psychological self-management approach to the disease management of breast cancer survivors. Innovative is the use of patients' own strengths as an explicit intervention target, which is hypothesized to serve as a buffer to prevent psychological distress in long-term survivorship. In case of proven (cost) effectiveness, the BREATH intervention can serve as a low-cost and easy-accessible intervention to facilitate emotional, physical and social recovery of all breast cancer survivors. TRIAL REGISTRATION: This study is registered at the Netherlands Trial Register (NTR2935).

Moderators and long-term effectiveness of cognitive behaviour therapy for fatigue during cancer treatment.

OBJECTIVE: A randomised controlled trial (RCT) demonstrated that cognitive behaviour therapy (CBT) for fatigue during curative cancer treatment was effective shortly after cancer treatment. This study aimed to identify which patient characteristics predict fatigue improvement after CBT. In addition, the long-term effectiveness was investigated. METHODS: Patients with various malignancies participated in the RCT (n = 210). Participants were assessed before cancer treatment (T1), postintervention (T2), which was at least 2 months after cancer treatment, and after 1-year follow-up (T3). Monthly fatigue assessments were completed between T2 and T3. A regression analysis with interactions was performed to determine if domains of quality of life (EORTC-QLQ-C30) functioning (Health Survey Short Form-36) or psychological distress (Symptom Checklist-90) moderated the effect of CBT on fatigue. Analyses of covariance were used to study the long-term effectiveness of CBT. RESULTS: Fatigue at T2 was predicted by a significant interaction between self-reported cognitive functioning and CBT. No interactions were found between other domains of quality of life, functioning, psychological distress and CBT. At T3, no significant difference on fatigue was found between CBT and usual care. Exploratory analyses showed that the difference nearly reached significance until 7 months postintervention. CONCLUSIONS: Patients who experienced more concentration and memory problems at T1 benefited more from CBT for fatigue and are indicators. After a year of follow-up, the effect of CBT for fatigue was no longer observed, and the effect on fatigue seemed to be diminished 7 months postintervention. The implication is that CBT for fatigue should be offered to patients with cancer with the highest chance to benefit.

Examining the role of physical activity in reducing postcancer fatigue.

PURPOSE: Persistent fatigue is a long-term adverse effect experienced in about a quarter of patients cured of cancer. It was shown that cognitive behavior therapy (CBT) especially designed for postcancer fatigue is highly effective in reducing severe fatigue. However, it is unclear by what mechanism the fatigue reduction is reached. In many fatigue reduction programs, an increase in physical activity is assumed to reduce fatigue. The purpose of the present study is to determine whether the effect of CBT on fatigue is mediated by an increase in physical activity. METHODS: Data of a previous randomized controlled trial on the efficacy of CBT for postcancer fatigue were reanalyzed (CBT, n = 41; waiting list condition, n = 42). Actigraphy was used to assess the level of objective physical activity. Cancer survivors were assessed prior as well as after the CBT and waiting list period. The mediation hypothesis was tested according to guidelines of Baron and Kenny. A non-parametric bootstrap approach was used to test statistical significance of the mediation effect. RESULTS: Although CBT effectively reduced postcancer fatigue, no change in level of objective physical activity was found. The mean mediation effect was 1.4% of the total treatment effect. This effect was not significant. CONCLUSION: The effect of CBT for postcancer fatigue is not mediated by a persistent increase in objective physical activity.

Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Protocol for a Cluster Randomized Trial and Trial-Based Economic Evaluation.

BACKGROUND: People with profound intellectual and multiple disabilities (PIMD) cannot communicate the need to change their incontinence products. The smart continence care (SCC) product Abena Nova signals caregivers when change is needed. This provides the opportunity for more person-centered care, increased quality of life, and a decreased number of leakages. However, there is a need for evidence of the effectiveness and cost-effectiveness of such technology compared with regular continence care (RCC) for people with PIMD. OBJECTIVE: This paper presents the research protocol for an effectiveness and cost-effectiveness study with people with PIMD living in long-term care facilities in the Netherlands. METHODS: A cluster randomized trial will be conducted in 3 consecutive waves across 6 long-term care providers for people with disabilities and 160 participants with PIMD. Long-term care providers are randomized at a 1:1 ratio, resulting in an intervention group and a group continuing RCC. The intervention group will receive implementation guidance and use SCC for 3 months; the other group will continue their RCC as usual and then switch to SCC. This study consists of three components: effectiveness study, economic evaluation, and process evaluation. The primary outcome will be a change in the number of leakages. The secondary outcomes are quality of life, the difference in the number of changes, the work perception of caregivers, cost-effectiveness, and cost utility. Data collection will occur at T0 (baseline), T1 (6 weeks), T2 (12 weeks), and T3 (9-month follow-up) for the first 2 intervention groups. An intention-to-treat analysis will be performed. The economic evaluation will be conducted alongside the trial from the societal and long-term care provider perspectives. Qualitative data collection through interviews and field notes will complement these quantitative results and provide input for the process evaluation. RESULTS: This research was funded in December 2019 by ZonMw, the Netherlands Organization for Health Research and Development. As of June 2022, we enrolled 118 of the 160 participants. The enrollment of participants will continue in the third and fourth quarters of 2022. CONCLUSIONS: This study will provide insights into the effectiveness and cost-effectiveness of SCC for people with PIMD, allowing long-term care providers to make informed decisions about implementing such a technology. This is the first time that such a large-scale study is being conducted for people with PIMD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05481840; https://clinicaltrials.gov/ct2/show/NCT05481840. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42555.

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.

Psychosocial interventions for reducing fatigue during cancer treatment in adults.

BACKGROUND: Fatigue is a common symptom in cancer patients receiving active treatment. There are a limited number of reviews evaluating interventions for fatigue during active treatment, and they are restricted to patients with advanced cancer, or to patients during radiotherapy. To date there is no systematic review on psychosocial interventions for fatigue during cancer treatment. OBJECTIVES: To evaluate if psychosocial interventions are effective in reducing fatigue in cancer patients receiving active treatment for cancer, and which types of psychosocial interventions are the most effective. SEARCH STRATEGY: In September 2008 we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), PUBMED, MEDLINE, EMBASE, CINAHL and PsycINFO, and checked the reference lists. SELECTION CRITERIA: Randomised controlled trials (RCTs) were included which evaluated psychosocial interventions in adult cancer patients during treatment, with fatigue as an outcome measure. DATA COLLECTION AND ANALYSIS: Three review authors independently extracted data from the selected studies, and assessed the methodological quality using several quality rating scales and additional criteria. MAIN RESULTS: Twenty-seven studies met the inclusion criteria with a total of 3324 participants, and seven studies reported significant effects of the psychosocial intervention on fatigue. In three studies the effect was maintained at follow-up. The quality of the studies was generally moderate. Effect sizes varied between 0.17 to 1.07.The effectiveness of interventions specific for fatigue was significantly higher (80%) compared to interventions not specific for fatigue (14%). In five studies the interventions were specifically focused on fatigue, with four being effective. The five interventions were brief, consisting of three individual sessions, provided by (oncology) nurses. In general, during these interventions participants were educated about fatigue, were taught in self-care or coping techniques, and learned activity management.Of the remaining 22 studies only three were effective in reducing fatigue, and these interventions had a more general approach. These interventions were aimed at psychological distress, mood and physical symptoms, and varied strongly in duration and content. AUTHORS' CONCLUSIONS: There is limited evidence that psychosocial interventions during cancer treatment are effective in reducing fatigue. At present, psychosocial interventions specifically for fatigue are a promising type of intervention. However, there is no solid evidence for the effectiveness of interventions not specific for fatigue. Most aspects of the included studies were heterogeneous, and therefore it could not be established which other types of interventions, or elements were essential in reducing fatigue.

Adapting an Evidence-Based Intervention to Address Targeted Therapy-Related Fatigue in Chronic Myeloid Leukemia Patients.

BACKGROUND: Fatigue is one of the most important quality of life issues experienced by patients being treated with oral targeted therapy for chronic myeloid leukemia (CML). However, no intervention exists that specifically addresses strategies to reduce targeted therapy-related fatigue. OBJECTIVE: This study adapted an evidence-based clinic-delivered intervention (EBI) "cognitive behavior therapy for post-cancer fatigue" for use in CML patients. The existing EBI was based on 6 established perpetuating factors of fatigue (ie, sleep, activity, helpful thinking, coping with cancer, social support, and fear of disease recurrence). Study aims were to gauge reactions to (1) existing content and (2) a new Internet-assisted intervention delivery format. METHODS: Guided by the ADAPT-ITT framework, we used a series of systematic steps and adaptation methodologies, including semistructured interviews with CML patients and providers and feedback from topical experts. RESULTS: Patients were receptive to existing content topics and an Internet-assisted delivery format was acceptable. A key theme reflected the need for a new customized psychoeducational module about CML as a disease and its treatment. Both providers and patients held positive views about the potential of the adapted EBI to improve fatigue. CONCLUSIONS: Findings offered essential guidance for the adaptation and reinforced the utility of the adapted intervention. IMPLICATIONS FOR PRACTICE: Adapting existing EBIs for new audiences contributes to advancing findings of evidence-based research, ultimately providing nurses and other healthcare providers with important referral options to interventions that may provide useful strategies to improve quality of life and reduce targeted therapy-related fatigue.

Are the effects of cognitive behavior therapy for severe fatigue in cancer survivors sustained up to 14 years after therapy?

PURPOSE: Cognitive behavior therapy (CBT) reduces cancer-related fatigue (CRF) in cancer survivors in the short term. We examined fatigue levels up to 14 years after CBT. METHODS: Eligible participants of two randomized controlled trials who had completed CBT for CRF and a post-treatment assessment were contacted (n = 81). Fatigue was assessed with the subscale "fatigue severity" of the Checklist Individual Strength (CIS-fatigue). The course of fatigue over time was examined with linear mixed model analyses. Fatigue levels of participants were compared to matched population controls at long-term follow-up. We tested with multiple regression analysis if fatigue at follow-up was predicted by the patients' fatigue level and fatigue-perpetuating factors directly after CBT (post-CBT). RESULTS: Seventy-eight persons completed a follow-up assessment (response rate = 96%, mean time after CBT = 10 years). The mean level of fatigue increased from 23.7 (SD = 11.1) at post-CBT to 34.4 (SD = 12.4) at follow-up (p < 0.001). Population controls (M = 23,9, SD = 11.4) reported lower fatigue levels than participants. Half of the patients (52%) who were recovered from severe fatigue at post-CBT (CIS-fatigue < 35) were still recovered at long-term follow-up. Patients with lower fatigue levels at post-CBT were less likely to show relapse. CONCLUSION: Despite initial improvement after CBT, levels of fatigue deteriorated over time. Half of the patients who were recovered from severe fatigue after CBT still scored within normal ranges of fatigue at long-term follow-up. IMPLICATIONS FOR CANCER SURVIVORS: It should be explored how to help patients with a relapse of severe fatigue following an initially successful CBT. They may profit from CBT again, or another evidence-based intervention for fatigue (like mindfulness or exercise therapy). Future research to gain insight into reasons for relapse is warranted.

Towards an evidence-based model of fear of cancer recurrence for breast cancer survivors.

PURPOSE: In order to understand the multidimensional mechanism of fear of cancer recurrence (FCR) and to identify potential targets for interventions, it is important to empirically test the theoretical model of FCR. This study aims at assessing the validity of Lee-Jones et al.'s FCR model. METHODS: A total of 1205 breast cancer survivors were invited to participate in this study. Participants received a questionnaire booklet including questionnaires on demographics and psychosocial variables including FCR. Data analysis consisted of the estimation of direct and indirect effects in mediator models. RESULTS: A total of 460 women (38 %) participated in the study. Median age was 55.8 years (range 32-87). Indirect effects of external and internal cues via FCR were found for all mediation models with limited planning for the future (R 2 = .28) and body checking (R 2 = .11-.15) as behavioral response variables, with the largest effects for limited planning for the future. A direct relation was found between feeling sick and seeking professional advice, not mediated by FCR. CONCLUSIONS: In the first tested models of FCR, all internal and external cues were associated with higher FCR. In the models with limited planning for the future and body checking as behavioral response, an indirect effect of cues via FCR was found supporting the theoretical model of Lee-Jones et al. IMPLICATIONS FOR CANCER SURVIVORS: An evidence-based model of FCR may facilitate the development of appropriate interventions to manage FCR in breast cancer survivors.

Fatigue in Advanced Cancer Patients: Congruence Between Patients and Their Informal Caregivers About Patients' Fatigue Severity During Cancer Treatment With Palliative Intent and Predictors of Agreement.

CONTEXT: Informal caregivers (ICs) are increasingly involved in the monitoring of symptoms during advanced cancer patients' treatment with palliative intent. A common but subjective symptom during this extended treatment phase is fatigue. OBJECTIVES: This exploratory longitudinal study aimed to determine agreement between patients and ICs about patients' fatigue severity. In addition, predictors of agreement over time were studied. METHODS: A sample of 107 patients with advanced cancer (life expectancy ≥ six months) and their ICs completed the subscale fatigue severity of the Checklist Individual Strength based on the patient's status at baseline and six months later. This eight-item subscale has a validated cutoff to determine the presence of clinically relevant levels of fatigue. ICs' own fatigue severity, strain, self-esteem, and relationship satisfaction were examined as predictors of agreement. RESULTS: A total of 107 dyads completed measures at baseline and 69 dyads six months later. At baseline, ICs' significantly overestimated patients' fatigue severity (P < 0.001) with a moderate amount of bias (Cohen's d = 0.48). In 81 of the 107 dyads (76%), there was congruence about the presence or absence of severe fatigue. On a group level, congruence did not significantly change over time. On a dyad level, there was a tendency to either remain congruent or reach congruence. Next to baseline congruence, ICs' fatigue severity and strain predicted ICs' fatigue ratings (R(2) = 0.22). CONCLUSION: Most ICs accurately predict presence or absence of clinically relevant levels of patients' fatigue. ICs' own fatigue severity and strain should be taken into account as they influence agreement.

Prevalence, Impact, and Correlates of Severe Fatigue in Patients With Gastrointestinal Stromal Tumors.

CONTEXT: The introduction of the tyrosine kinase inhibitor (TKI) imatinib in the treatment of gastrointestinal stromal tumor (GIST) in 2000 was the start of a new era of targeted treatment. Since then, the median survival of patients with GIST has substantially increased. Prolonged survival and chronic TKI use are associated with treatment-induced symptoms, such as fatigue, which can compromise quality of life (QoL). OBJECTIVES: This study determined the prevalence of severe fatigue in GIST patients compared to matched healthy controls, the impact of fatigue on daily life, and associations between fatigue and current TKI use. METHODS: One hundred nineteen patients treated with surgery and/or a TKI for GIST were asked to participate. Participants completed questionnaires including the Checklist Individual Strength-Fatigue Severity scale (CIS-fatigue), Short-Form 36-Item Health Survey, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, Fatigue Catastrophizing Scale, Self-Efficacy Scale, and the Hospital Anxiety and Depression Scale. RESULTS: Eighty-nine GIST patients (75%) completed questionnaires, 61 patients (69%) were on a TKI. Prevalence of severe fatigue measured with CIS-fatigue was significantly higher in GIST patients (30%) than in 234 matched healthy controls (15%). The prevalence of severe fatigue did not differ significantly between patients receiving treatment with curative (29%) or palliative intent (36%). Severely fatigued patients reported lower QoL and more impairment on all functional domains. TKI use, more psychological distress, and lower physical functioning were associated with fatigue. CONCLUSION: Severe fatigue occurs in 30% of GIST patients and in 33% of GIST patients on a TKI. The fatigue is disabling and is not only associated with current TKI use but also with psychological distress and physical functioning. GIST patients should be informed about these associated factors of fatigue that deserve appropriate management.

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.

The effects of cognitive behavioral therapy for postcancer fatigue on perceived cognitive disabilities and neuropsychological test performance.

CONTEXT: After successful cancer treatment, a substantial number of survivors continue to experience fatigue and related concentration and memory problems. Severe fatigue after cancer treatment can be treated effectively with cognitive behavioral therapy (CBT), but it is unclear whether CBT has an effect on cognitive functioning. OBJECTIVES: We hypothesized that patients would report less cognitive disability after treatment with CBT for cancer-related fatigue. CBT was not expected to affect neuropsychological test performance, as it has been shown that fatigue is not associated with test performance. METHODS: Data were used from a randomized controlled trial in which 98 severely fatigued cancer survivors, treated at least one year previously, were assessed at baseline (T1) and six months post-baseline (T2). Patients were randomly assigned to receive CBT (n = 50) or to a waiting list (WL) control condition (n = 48). Self-reported cognitive disability was assessed by the Concentration subscale of the Checklist Individual Strength and the Alertness Behavior subscale of the Sickness Impact Profile. Neuropsychological test performance was measured by the symbol digit modalities task and two reaction time tasks. RESULTS: Patients who received CBT for post-cancer fatigue reported significantly less cognitive disability compared with those in the WL group. CBT also was associated with a clinically relevant reduction in concentration problems (CBT, 32% vs. WL, 2%). There were no significant differences in neuropsychological test performance between the CBT and WL groups. CONCLUSION: CBT for post-cancer fatigue has already been shown to be an effective therapy. The present study demonstrates that CBT also may lead to a decrease in perceived cognitive disability.