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Background Cognitive behavioral therapy for targeted-therapy related fatigue (CBT-TTF) has demonstrated preliminary efficacy in reducing fatigue in patients treated with tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia (CML). Purpose The aim of the current analyses was to explore whether fatigue perpetuating factors (disturbed sleep/wake cycle, dysregulated activity patterns, maladaptive cognitions about fatigue and cancer, insufficient processing of cancer and treatment, inadequate social support and interactions, heightened fear of cancer progression) changed over time in patients receiving CBT-TTF, and whether the effect of CBT-TTF on fatigue was mediated by these factors. Methods Secondary data analyses were conducted from a pilot randomized controlled trial. Patients with CML treated with a TKI who reported moderate to severe fatigue were randomized 2:1 to CBT-TTF delivered via FaceTime for iPad or a waitlist control condition (WLC). Self-report measures of fatigue and fatigue perpetuating factors were obtained before randomization and post-intervention (i.e., approximately 18 weeks later). Mixed model and mediation analyses using bootstrap methods were used. Results A total of 36 participants (CBT-TTF n = 22, WLC n = 14) who had baseline and 18-week follow-up data and attended >5 sessions for CBT-TTF were included. Participants randomized to CBT-TTF reported improvements in activity (mental, physical, social, p’s ≤ .023) and cognitions (helplessness, catastrophizing, focusing on symptoms, self-efficacy, p’s ≤ .003) compared to WLC. Mental activity, social activity, self-efficacy, helplessness, and focusing on symptoms, as well as sleep and insufficient processing (avoidance) mediated the relationship between treatment group and fatigue. Conclusions CBT-TTF appears to improve TKI-related fatigue in CML patients through changes in behavior (sleep, activity patterns) and cognitions about fatigue and cancer. A larger randomized controlled trial is warranted to confirm these findings.

Contains fulltext : 248803.pdf (Publisher’s version ) (Open Access) BACKGROUND: Cancer-related fatigue is a debilitating late effect after treatment for childhood cancer. The prevalence of fatigue in childhood cancer survivors (CCSs) and associated factors for fatigue has varied widely in previous studies. Two important aspects of cancer-related fatigue, its severity and chronicity, are often not assessed. This study investigated the prevalence of, and risk factors for, severe chronic fatigue (CF) in a national cohort of Dutch CCSs. METHODS: In this study, 2810 CCSs (5-year survivors of all childhood malignancies diagnosed between 1963 and 2001 with a current age of 12-65 years) and 1040 sibling controls were included. CF was assessed with the Short Fatigue Questionnaire and was defined as a score ≥ 18 and persistence of fatigue for ≥6 months. Cancer- and treatment-related characteristics, current health problems, and demographic and lifestyle variables were assessed as potential risk factors for CF via multivariable logistic regression analyses. RESULTS: In adult CCSs and sibling controls (≥18 years old), the prevalence of CF was 26.1% and 14.1%, respectively (P < .001). In adolescent CCSs and sibling controls (2, 2.20; 95% CI, 1.50-3.21), and a central nervous system diagnosis (OR, 1.74; 95% CI, 1.17-2.60) were significantly associated with CF in adult CCSs. CONCLUSIONS: This study shows that CCSs, regardless of their cancer diagnosis, report CF more often than sibling controls. This study provides new evidence for the prevalence of fatigue in CCSs.

OBJECTIVE: Fatigue is a common symptom among cancer survivors that can be successfully treated with cognitive-behavioral therapy (CBT). Insights into the working mechanisms of CBT are currently limited. The aim of this study was to investigate whether improvements in targeted cognitive-behavioral variables and reduced depressive symptoms mediate the fatigue-reducing effect of CBT.METHODS: We pooled data from three randomized controlled trials that tested the efficacy of CBT to reduce severe fatigue. In all three trials, fatigue severity (checklist individual strength) decreased significantly following CBT. Assessments were conducted pre-treatment and 6 months later. Classical mediation analysis testing a pre-specified model was conducted and its results compared to those of causal discovery, an explorative data-driven approach testing all possible causal associations and retaining the most likely model.RESULTS: Data from 250 cancer survivors (n=129 CBT, n=121 waitlist) were analyzed. Classical mediation analysis suggests that increased self-efficacy and decreased fatigue catastrophizing, focusing on symptoms, perceived problems with activity and depressive symptoms mediate the reduction of fatigue brought by CBT. Conversely, causal discovery and post-hoc analyses indicate that fatigue acts as mediator, not outcome, of changes in cognitions, sleep disturbance and depressive symptoms.CONCLUSIONS: Cognitions, sleep disturbance and depressive symptoms improve during CBT. When assessed pre- and post-treatment, fatigue acts as a mediator, not outcome, of these improvements. It seems likely that the working mechanism of CBT is not a one-way causal effect but a dynamic reciprocal process. Trials integrating intermittent assessments are needed to shed light on these mechanisms and inform optimization of CBT. This article is protected by copyright. All rights reserved.

ObjectivePsychosocial 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.MethodsData 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).ResultsStatistically significant, small overall effects of psychosocial interventions on fatigue were found (breast cancer: β = -0.19 [95% confidence interval (95%CI) = -0.30; -0.08]; prostate cancer: β = -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 (β = -0.27 [95%CI = -0.40; -0.15]), fatigue-specific interventions (β = -0.48 [95%CI = -0.79; -0.18]), and interventions that only targeted patients with clinically relevant fatigue (β = -0.85 [95%CI = -1.40; -0.30]).ConclusionsOur 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.

Patient-generated health data (PGHD), or health-related data gathered from patients to help address a health concern, are used increasingly in oncology to make regulatory decisions and evaluate quality of care. PGHD include self-reported health and treatment histories, patient-reported outcomes (PROs), and biometric sensor data. Advances in wireless technology, smartphones, and the Internet of Things have facilitated new ways to collect PGHD during clinic visits and in daily life. The goal of the current review was to provide an overview of the current clinical, regulatory, technological, and analytic landscape as it relates to PGHD in oncology research and care. The review begins with a rationale for PGHD as described by the US Food and Drug Administration, the Institute of Medicine, and other regulatory and scientific organizations. The evidence base for clinic-based and remote symptom monitoring using PGHD is described, with an emphasis on PROs. An overview is presented of current approaches to digital phenotyping or device-based, real-time assessment of biometric, behavioral, self-report, and performance data. Analytic opportunities regarding PGHD are envisioned in the context of big data and artificial intelligence in medicine. Finally, challenges and solutions for the integration of PGHD into clinical care are presented. The challenges include electronic medical record integration of PROs and biometric data, analysis of large and complex biometric data sets, and potential clinic workflow redesign. In addition, there is currently more limited evidence for the use of biometric data relative to PROs. Despite these challenges, the potential benefits of PGHD make them increasingly likely to be integrated into oncology research and clinical care.

Cancer-related fatigue is one of the most common impairments in HL patients and survivors. Symptoms of cancer-related fatigue deserve attention because they are associated with adverse effects on psychological well-being and everyday life including family, work and social reintegration. Early identification of affected individuals and further development of therapeutic interventions are therefore of major importance.

Background and ObjectivesThe pathophysiology of chronic fatigue syndrome (CFS) and Q fever fatigue syndrome (QFS) remains elusive. Recent data suggest a role for neuroinflammation as defined by increased expression of translocator protein (TSPO). In the present study, we investigated whether there are signs of neuroinflammation in female patients with CFS and QFS compared with healthy women, using PET with the TSPO ligand 11C-(R)-(2-chlorophenyl)-N-methyl-N-(1-methylpropyl)-3-isoquinoline-carbox-amide ([11C]-PK11195).MethodsThe study population consisted of patients with CFS (n = 9), patients with QFS (n = 10), and healthy subjects (HSs) (n = 9). All subjects were women, matched for age (±5 years) and neighborhood, aged between 18 and 59 years, who did not use any medication other than paracetamol or oral contraceptives, and were not vaccinated in the last 6 months. None of the subjects reported substance abuse in the past 3 months or reported signs of underlying psychiatric disease on the Mini-International Neuropsychiatric Interview. All subjects underwent a [11C]-PK11195 PET scan, and the [11C]-PK11195 binding potential (BPND) was calculated.ResultsNo statistically significant differences in BPND were found for patients with CFS or patients with QFS compared with HSs. BPND of [11C]-PK11195 correlated with symptom severity scores in patients with QFS, but a negative correlation was found in patients with CFS.DiscussionIn contrast to what was previously reported for CFS, we found no significant difference in BPND of [11C]-PK11195 when comparing patients with CFS or QFS with healthy neighborhood controls. In this small series, we were unable to find signs of neuroinflammation in patients with CFS and QFS.Trial Registration InformationEudraCT number 2014-004448-37.

Background Fear of cancer recurrence, depressive symptoms, and cancer-related fatigue are prevalent symptoms among cancer survivors, adversely affecting patients’ quality of life and daily functioning. Effect sizes of interventions targeting these symptoms are mostly small to medium. Personalizing treatment is assumed to improve efficacy. However, thus far the empirical support for this approach is lacking. The aim of this study is to investigate if systematically personalized cognitive behavioral therapy is more efficacious than standard cognitive behavioral therapy in cancer survivors with moderate to severe fear of cancer recurrence, depressive symptoms, and/or cancer-related fatigue. Methods The study is designed as a non-blinded, multicenter randomized controlled trial with two treatment arms (ratio 1:1): (a) systematically personalized cognitive behavioral therapy and (b) standard cognitive behavioral therapy. In the standard treatment arm, patients receive an evidence-based diagnosis-specific treatment protocol for fear of cancer recurrence, depressive symptoms, or cancer-related fatigue. In the second arm, treatment is personalized on four dimensions: (a) the allocation of treatment modules based on ecological momentary assessments, (b) treatment delivery, (c) patients’ needs regarding the symptom for which they want to receive treatment, and (d) treatment duration. In total, 190 cancer survivors who experience one or more of the targeted symptoms and ended their medical treatment with curative intent at least 6 months to a maximum of 5 years ago will be included. Primary outcome is limitations in daily functioning. Secondary outcomes are level of fear of cancer recurrence, depressive symptoms, fatigue severity, quality of life, goal attainment, therapist time, and drop-out rates. Participants are assessed at baseline (T0), and after 6 months (T1) and 12 months (T2). Discussion To our knowledge, this is the first randomized controlled trial comparing the efficacy of personalized cognitive behavioral therapy to standard cognitive behavioral therapy in cancer survivors. The study has several innovative characteristics, among which is the personalization of interventions on several dimensions. If proven effective, the results of this study provide a first step in developing an evidence-based framework for personalizing therapies in a systematic and replicable way. Trial registration The Dutch Trial Register (NTR) NL7481 (NTR7723). Registered on 24 January 2019.

Fatigue is a dominant feature of both acute and convalescent coronavirus disease 2019 (COVID-19) (sometimes termed “long-COVID”), with up to 46% of patients reporting fatigue that lasts from weeks to months. The investigators of the international Collaborative on Fatigue Following Infection (COFFI) conducted a systematic review of post-COVID fatigue and a narrative review on fatigue after other infections, and made recommendations for clinical and research approaches to assessing fatigue after COVID-19. In the majority of COVID-19 cohort studies, persistent fatigue was reported by a significant minority of patients, ranging from 13% to 33% at 16–20 weeks post-symptom onset. Data from the prospective cohort studies in COFFI and others indicate that fatigue is also a prevalent outcome from many acute systemic infections, notably infectious mononucleosis, with a case rate for clinically significant Post-infective fatigue after exclusion of recognized medical and psychiatric causes, ranging from 10%–35% at 6 months. To better characterize post-COVID fatigue, the COFFI investigators recommend the following: application of validated screening questionnaires for case detection; standardized interviews encompassing fatigue, mood, and other symptoms; and investigative approaches to identify end-organ damage and mental health conditions., Fatigue after COVID-19 is common but generally resolves over months, like other postinfective fatigue states. Post-COVID fatigue results from end-organ injury, mental health conditions, or idiopathic post-COVID fatigue. Post-COVID fatigue should be assessed with validated questionnaires, interviews, and protocolized investigations.

Introduction Psychological distress and fatigue are common in persons with diabetes, adversely affecting quality of life and complicating diabetes self-management. Offering diabetes-specific self-guided cognitive behavioral therapy (CBT) may be helpful for persons with diabetes and mild symptoms of psychological distress and fatigue. We are the first to test the feasibility and user experiences of a web-based self-help app called ‘MyDiaMate’ in adults with type 1 and type 2 diabetes. Methods and materials MyDiaMate was developed in close collaboration with persons with diabetes and professionals, building on elements from existing (guided) diabetes-specific CBT interventions. The study was advertised, offering free access to the app for adults with diabetes for a period of three months. Feasibility and user experiences were tested in a non-randomized study with pre- and post- measurements and interviews in a small sample.. In addition usage of the app was studied using log-data.. Results In total N = 55 adults with diabetes signed up for the study. Mean age was M = 42.7 (SD = 15.6), mostly women (n = 39, 70.9%), higher educated (n = 36, 65.5%), and diagnosed with type 1 diabetes (n = 37, 67.3%). About half reported current or a history of psychological complaints. All the participants completed baseline assessments, and n = 32 participants (58%) completed the follow-up questionnaire. Main reasons for participating in the study were: to preserve or improve mental fitness (40.6%), curiosity (25.0%) and wanting to contribute to research (34.4%). No major technical issues were encountered in accessing or using the app. The app was opened at least once by n = 51 participants, median use of the modules was 28 min (1–80) within a period of 1 to 92 days (median = 10). Almost all participants (n = 50, 98.0%) opened the basic module ‘Diabetes in balance’, of whom 32 (62.7%) completed this module. ‘My mood’ and ‘My energy’ were opened by n = 40 (78.4%) and n = 32 (62.7%) participants, respectively, and completed by n = 21 (52.5%) and n = 9 (28.1%) of the participants. Of all participants, 40.6% would recommend the app to others living with diabetes. Conclusions This study confirmed the feasibility of MyDiaMate as a diabetes-specific self-guided app for adults wishing to preserve or improve their psychological health. While user experiences were overall positive, further tailoring the content to individual needs and preferences could enhance uptake, usage and appreciation. Future research should explore its effectiveness in a randomized controlled trial., Highlights • MyDiaMate is the first diabetes-specific self-help app to help prevent and reduce psychological distress and fatigue. • The study shows promising results in terms of feasibility and user experiences of the app. • Personalizing content may further improve engagement and appreciation. • Further research should test the efficacy with regard to reduction and prevention of psychological distress and fatigue.

Background Insomnia is common in people with long-term medical conditions and is related to increased mortality and morbidity. Cognitive behavioral therapy for insomnia (CBT-I) is first choice treatment and effective for people with insomnia and comorbid long-term medical conditions. However, CBT-I has some limitations as it might not always be available or appeal to patients with medical conditions. Furthermore, a small proportion of patients do not respond to CBT-I. Preliminary evidence and clinical experience suggest that low dose amitriptyline (AM) might be an effective alternative to treat insomnia in patients with medical comorbidity. In this randomized controlled trial we will determine whether AM is non-inferior to the first choice treatment for insomnia, CBT-I.Methods / design This study will test if treatment with low dose amitriptyline for insomnia in patients with medical comorbidity is non-inferior to CBT-I in a multicenter randomized controlled non-inferiority trial. Participants will be 190 adults with a long-term medical condition and insomnia. Participants will be randomly allocated to one of two intervention arms: 12 weeks AM (starting with 10 mg per day, and if ineffective at 3 weeks, doubling this dose) or 12 weeks of CBT-I consisting of 6 weekly sessions and a follow up session 6 weeks later. The primary outcome is subjective insomnia severity, measured with the Insomnia Severity Index (ISI). The primary endpoint is at 12 weeks. Secondary outcomes include sleep quality (e.g. sleep efficiency), questionnaires on daytime functioning (physical functioning and impairment of functioning) and symptoms (e.g. fatigue, pain, anxiety) at 12 weeks and 12 months post treatment and relapse of insomnia until 12 months after treatment. Discussion Irrespective of the outcome, this study will be a much-needed contribution to evidence based clinical guidelines on the treatment of insomnia in patients with medical comorbidity. Trail registration Dutch Trial Register, NTR NL7971, 18 August 2019

Background Internet-based cognitive behavior therapy (I-CBT) for adolescents with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) has been shown to be effective in a randomized controlled trial (RCT; Fatigue in Teenagers on the Internet [FITNET]). FITNET can cause a significant reduction in fatigue and disability. Objective We aimed to investigate whether FITNET treatment implemented in routine clinical care (IMP-FITNET) was as effective, using the outcomes of the FITNET RCT as the benchmark. Methods Outcomes of CFS/ME adolescents who started IMP-FITNET between October 2012 and March 2018 as part of routine clinical care were compared to the outcomes in the FITNET RCT. The primary outcome was fatigue severity assessed posttreatment. The secondary outcomes were self-reported physical functioning, school attendance, and recovery rates. Clinically relevant deterioration was assessed posttreatment, and for this outcome, a face-to-face CBT trial was used as the benchmark. The attitude of therapists toward the usability of IMP-FITNET was assessed through semistructured interviews. The number of face-to-face consultations during IMP-FITNET was registered. Results Of the 384 referred adolescents with CFS/ME, 244 (63.5%) started IMP-FITNET, 84 (21.9%) started face-to-face CBT, and 56 (14.6%) were not eligible for CBT. Posttreatment scores for fatigue severity (mean 26.0, SD 13.8), physical functioning (mean 88.2, SD 15.0), and full school attendance (mean 84.3, SD 26.5) fell within the 95% CIs of the FITNET RCT. Deterioration of fatigue and physical functioning after IMP-FITNET was observed at rates of 1.2% (n=3) and 4.1% (n=10), respectively, which is comparable to a waiting list condition (fatigue: 1.2% vs 5.7%, χ21=3.5, P=.06; physical functioning: 4.1% vs 11.4%, χ21=3.3, P=.07). Moreover, 41 (16.8%) IMP-FITNET patients made use of face-to-face consultations. Conclusions IMP-FITNET is an effective and safe treatment for adolescents with CFS/ME in routine clinical care.

Objective The primary aim of the current study was to objectify a spectrum of persisting subjective psychological complaints in patients with hypopituitarism, at least six months after normalizing of the hormonal disturbances. Also, gender differences on these outcomes were investigated. The secondary aim was to identify illness perceptions and causal attributions within this patient group. Methods A total of 42 adult participants (60% females) with treated hypopituitarism once filled out a number of psychological questionnaires. The Profile of Mood States (POMS) and the Hospital Anxiety and Depression Scale (HADS) assessed mood and the Symptom Checklist-90 (SCL-90) and the Work and Social Adjustment Scale (WSAS) assessed well-being. Illness perceptions were identified using the Illness Perceptions Questionnaire-Brief Dutch Language Version (IPQ-B DLV) and causal attributions by using the Causal Attribution List (CAL). Patient outcomes were compared to reference values of healthy norm groups. Results Participants scored significantly worse on the POMS depression, anger, fatigue and tension subscales, the SCL-90 psychoneuroticism, depression, inadequacy of thinking and acting and sleeping problems subscales and all subscales of the WSAS when compared to reference data. Women also scored worse on depression (HADS) and somatic symptoms (SCL-90). Compared to other illnesses, patients with hypopituitarism have more negative and realistic illness perceptions on consequences, timeline, identity and emotions. Participants attributed their complaints more to physical causes than psychological causes. Conclusion Despite normalization of hormonal disturbances, patients with hypopituitarism in general can still experience problems during daily living, such as negative mood states and a decreased psychological well-being.

Summary: Background: Concerns about long-lasting symptoms attributed to Lyme borreliosis (LB) are widespread in the Western world, while such symptoms are highly prevalent in the general population. Methods: In the largest prospective study to date, adults with physician-confirmed LB were included at the start of antibiotic treatment. Primary outcomes, prevalence of persistent symptoms and symptom severity, were assessed using three-monthly standardised questionnaires during one year. Persistent symptoms were defined as impaired scores for fatigue (CIS, subscale fatigue), cognitive impairment (CFQ) or pain (SF-36, subscale bodily pain) ≥6 months, with onset

Abstract The FITNET-NHS Trial is a UK, national, trial investigating whether an online cognitive behavioural therapy program (FITNET-NHS) for treating chronic fatigue syndrome/ME in adolescents is clinically effective and cost-effective in the NHS. At the time of writing (September 2019), the trial was recruiting participants. This article presents an update to the planned sample size and data collection duration previously published within the trial protocol. Trial registration ISRCTN, ID: 18020851. Registered 8 April 2016.

Background A debilitating late effect for childhood cancer survivors (CCS) is cancer-related fatigue (CRF). Little is known about the prevalence and risk factors of fatigue in this population. Here we describe the methodology of the Dutch Childhood Cancer Survivor Late Effect Study on fatigue (DCCSS LATER fatigue study). The aim of the DCCSS LATER fatigue study is to examine the prevalence of and factors associated with CRF, proposing a model which discerns predisposing, triggering, maintaining and moderating factors. Triggering factors are related to the cancer diagnosis and treatment during childhood and are thought to trigger fatigue symptoms. Maintaining factors are daily life- and psychosocial factors which may perpetuate fatigue once triggered. Moderating factors might influence the way fatigue symptoms express in individuals. Predisposing factors already existed before the diagnosis, such as genetic factors, and are thought to increase the vulnerability to develop fatigue. Methodology of the participant inclusion, data collection and planned analyses of the DCCSS LATER fatigue study are presented. Results Data of 1955 CCS and 455 siblings was collected. Analysis of the data is planned and we aim to start reporting the first results in 2022. Conclusion The DCCSS LATER fatigue study will provide information on the epidemiology of CRF and investigate the role of a broad range of associated factors in CCS. Insight in associated factors for fatigue in survivors experiencing severe and persistent fatigue may help identify individuals at risk for developing CRF and may aid in the development of interventions.

Purpose: Tyrosine kinase inhibitors (TKIs) substantially improve survival for patients with chronic myeloid leukemia (CML), but fatigue associated with TKIs can negatively impact patients’ quality of life and adherence. This study sought to identify correlates of fatigue (e.g., sociodemographic characteristics, clinical characteristics, health behaviors) among patients with CML taking TKIs who reported moderate to severe fatigue. Methods: Adults with CML experiencing at least moderate fatigue were recruited for a pilot trial of a cognitive behavioral intervention to improve fatigue. Data collected pre-intervention were used to explore concurrent correlates of fatigue in univariate and multivariable models. Results: Participants (N = 44, 48% female) were M = 55.6 years old (SD = 12.6) and had been diagnosed with CML M = 5.2 years prior (SD = 5.3). Participants had been taking their current TKI for M = 2.5 years (SD = 2.7). Most participants (64%) had previously been treated with ≥ 1 other TKI. More than three-quarters of participants (77%) reported severe fatigue. In univariate models, worse fatigue was associated with higher BMI (r = -0.36, p = 0.018), prior treatment with other TKI(s) (r = − 0.34, p = 0.024), worse sleep disturbance (r = − 0.51, p < 0.001), and less physical activity (r = 0.31, p = 0.043). In a multivariable model, significant univariate correlates accounted for 39% of the variance in fatigue. Worse fatigue remained significantly correlated with higher BMI (β = − 0.33, p = 0.009) and more disturbed sleep (β = − 0.45, p < 0.001). Conclusion: Results may inform future research aiming to identify fatigued patients with CML at risk for experiencing more severe fatigue during TKI therapy. Identifying predictors of fatigue severity could aid clinicians in identifying which patients will benefit from referrals to supportive therapy. Trial registration: NCT02592447, October 30, 2015

Contains fulltext : 235393.pdf (Publisher’s version ) (Closed access) Purpose: Cancer-related fatigue is a burdensome late effect of cancer treatment. A pilot study showed the effectiveness of cognitive-behavioral therapy (CBT) in fatigued survivors of childhood cancer (CCS). The aim of this study is to investigate whether the six cognitive-behavioral factors that are addressed during CBT differ in CCS compared with patients with chronic fatigue syndrome (CFS) and survivors of adult-onset cancer (ACS). Levels of self-esteem, optimism, and depressive symptoms, variables that are also related to fatigue, were also compared between groups. Methods: Retrospective analyses were performed on 34 CCS (ages 11-42 years), 102 patients with CFS, and 95 ACS who were referred for evaluation of severe fatigue. Fatigue severity, possible cognitive-behavioral fatigue maintaining factors, depressive symptoms, self-esteem, and optimism were assessed using questionnaires and actigraphy. Results: No significant differences were found in the factors coping with the experience of having had cancer, fear of cancer recurrence, physical activity, and in levels of self-esteem and optimism. CCS attributed their fatigue significantly more often to psychosocial causes and reported fewer problems in sleep/rest compared with patients with CFS. Compared with ACS, CCS reported significantly more social support, more problems in sleep/rest, and more depressive symptoms. Conclusions: There is substantial overlap in cognitive-behavioral factors that can maintain fatigue between CCS and CFS patients or ACS. Also differences were found regarding attribution of fatigue, the sleep/rest pattern, social support, and depressive symptoms that might have clinical implications when CBT for fatigue is provided to CCS.

Objective:There is limited research examining the impact of the validity of cognitive test performance on treatment outcome. All known studies to date have operationalized performance validity dichotomously, leading to the loss of predictive information. Using the range of scores on a performance validity test (PVT), we hypothesized that lower performance at baseline was related to a worse treatment outcome following cognitive behavioral therapy (CBT) in patients with Chronic Fatigue Syndrome (CFS) and to lower adherence to treatment.Method:Archival data of 1081 outpatients treated with CBT for CFS were used in this study. At baseline, all patients were assessed with a PVT, the Amsterdam Short-Term Memory test (ASTM). Questionnaires assessing fatigue, physical disabilities, psychological distress, and level of functional impairment were administered before and after CBT.Results:Our main hypothesis was not confirmed: the total ASTM score was not significantly associated with outcomes at follow-up. However, patients with a missing follow-up assessment had a lower ASTM performance at baseline, reported higher levels of physical limitations, and completed fewer therapy sessions.Conclusions:CFS patients who scored low on the ASTM during baseline assessment are more likely to complete fewer therapy sessions and not to complete follow-up assessment, indicative of limited adherence to treatment. However, if these patients were retained in the intervention, their response to CBT for CFS was comparable with subjects who score high on the ASTM. This finding calls for more research to better understand the impact of performance validity on engagement with treatment and outcomes.

BackgroundThe European OPTIMISTIC clinical trial has demonstrated a significant, yet heterogenous effect of Cognitive Behavioural Therapy (CBT) for Myotonic Dystrophy type 1 (DM1) patients. One of its remaining aims was the assessment of efficacy and adequacy of clinical outcome measures, including the relatively novel primary trial outcome, the DM1-Activ-c questionnaire.ObjectivesAssessment of the relationship between the Rasch-built DM1-Activ-c questionnaire and 26 commonly used clinical outcome measurements. Identification of variables associated with CBT response in DM1 patients.MethodsRetrospective analysis of the to date largest clinical trial in DM1 (OPTIMISTIC), comprising of 255 genetically confirmed DM1 patients randomized to either standard care or CBT with optionally graded exercise therapy. Correlations of 27 different outcome measures were calculated at baseline (cross-sectional) and of their respective intervention induced changes (longitudinal). Bootstrap enhanced Elastic-Net (BeEN) regression was validated and implemented to select variables associated with CBT response.ResultsIn cross-sectional data, DM1-Activ-c correlated significantly with the majority of other outcome measures, including Six Minute Walk Test and Myotonic Dystrophy Health Index. Fewer and weaker significant longitudinal correlations were observed. Nine variables potentially associated with CBT response were identified, including measures of disease severity, executive cognitive functioning and perceived social support.ConclusionsThe DM1-Activ-c questionnaire appears to be a well suited cross-sectional instrument to assess a variety of clinically relevant dimensions in DM1. Yet, apathy and experienced social support measures were less well captured. CBT response was heterogenous, requiring careful selection of outcome measures for different disease aspects.

Background Coronavirus disease 2019 (COVID-19) results in debilitating long-term symptoms, often referred to as Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), in a substantial subgroup of patients. One of the most prevalent symptoms following COVID-19 is severe fatigue. Prompt delivery of cognitive behavioural therapy (CBT), an evidence-based treatment that has shown benefit in reducing severe fatigue in other conditions, may reduce post-COVID-19 fatigue. Based on an existing CBT protocol, a blended intervention of 17 weeks, Fit after COVID, was developed to treat severe fatigue after the acute phase of infection with SARS-CoV-2. Method The ReCOVer study is a multicentre 2-arm randomised controlled trial (RCT) to test the efficacy of Fit after COVID on severe post-infectious fatigue. Participants are eligible if they report severe fatigue 3 up to and including 12 months following COVID-19. One hundred and fourteen participants will be randomised to either Fit after COVID or care as usual (ratio 1:1). The primary outcome, the fatigue severity subscale of the Checklist Individual Strength (CIS-fatigue), is assessed in both groups before randomisation (T0), directly post CBT or following care as usual (T1), and at follow-up 6 months after the second assessment (T2). In addition, a long-term follow-up (T3), 12 months after the second assessment, is performed in the CBT group only. The primary objective is to investigate whether CBT will lead to a significantly lower mean fatigue severity score measured with the CIS-fatigue across the first two follow-up assessments (T1 and T2) as compared to care as usual. Secondary objectives are to determine the proportion of participants no longer being severely fatigued (operationalised in different ways) at T1 and T2 and to investigate changes in physical and social functioning, in the number and severity of somatic symptoms and in problems concentrating across T1 and T2. Discussion This is the first trial testing a cognitive behavioural intervention targeting severe fatigue after COVID-19. If Fit after COVID is effective in reducing fatigue severity following COVID-19, this intervention could contribute to alleviating the long-term health consequences of COVID-19 by relieving one of its most prevalent and distressing long-term symptoms. Trial registration Netherlands Trial Register NL8947. Registered on 14 October 2020.

Background Effectiveness of psychological treatment is often assessed using patient-reported health evaluations. However, comparison of such scores over time can be hampered due to a change in the meaning of self-evaluations, called ‘response shift’. Insight into the occurrence of response shift seems especially relevant in the context of psychological interventions, as they often purposefully intend to change patients’ frames of reference. Aims The overall aim is to gain insight into the general relevance of response shift for psychological health intervention research. Specifically, the aim is to re-analyse data of published randomized controlled trials (RCTs) investigating the effectiveness of psychological interventions targeting different health aspects, to assess (1) the occurrence of response shift, (2) the impact of response shift on interpretation of treatment effectiveness, and (3) the predictive role of clinical and background variables for detected response shift. Method We re-analysed data from RCTs on guided internet delivered cognitive behavioural treatment (CBT) for insomnia in the general population with and without elevated depressive symptoms, an RCT on meaning-centred group psychotherapy targeting personal meaning for cancer survivors, and an RCT on internet-based CBT treatment for persons with diabetes with elevated depressive symptoms. Structural equation modelling was used to test the three objectives. Results We found indications of response shift in the intervention groups of all analysed datasets. However, results were mixed, as response shift was also indicated in some of the control groups, albeit to a lesser extent or in opposite direction. Overall, the detected response shifts only marginally impacted trial results. Relations with selected clinical and background variables helped the interpretation of detected effects and their possible mechanisms. Conclusion This study showed that response shift effects can occur as a result of psychological health interventions. Response shift did not influence the overall interpretation of trial results, but provide insight into differential treatment effectiveness for specific symptoms and/or domains that can be clinically meaningful.

Objective Fatigue remains one of the most common and distressing symptoms during treatment for advanced cancer. The TIRED trial demonstrated cognitive behavior therapy's (CBT) significant and clinically relevant effects to reduce fatigue among patients with advanced cancer, while graded exercise therapy (GET) did not prove beneficial. The present study aims to determine the mechanisms by which CBT and GET affect fatigue. Method The TIRED trial randomized 134 patients with advanced cancer to CBT (n = 46), GET (n = 42), or usual care (n = 46). At 14 weeks, 126 evaluable patients provided fatigue data and of those 117 received ≥1 CBT or GET session or usual care. We tested a prespecified multiple mediation model with four potential mediators (physical activity, exercise capacity, self-efficacy, and fatigue catastrophizing) assessed at baseline and at 14 weeks. Post-hoc analyses also included perceived physical activity and emotional functioning as potential mediators. Results A total of 82 of 117 patients completed all required measures. CBT reduced fatigue indirectly through its effect on self-efficacy, ab = -3.292; 97.5% bootstrap CI [-6.518 to -0.598]. CBT participants experienced an increase in fatigue self-efficacy, with greater self-efficacy associated with decreased fatigue severity. There was no evidence that changes in physical activity, exercise capacity, perceived physical activity, fatigue catastrophizing, or emotional functioning mediated CBT's or GET's effects on fatigue. Conclusions The effect of CBT was attributable to changes in cognition, that is, increased self-efficacy led to reduced fatigue severity. No significant mediators for GET were found. The findings inform further refinement of interventions for fatigue in this seriously ill population. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

ObjectiveTo assess the association between variant repeat (VR) interruptions in patients with myotonic dystrophy type 1 (DM1) and clinical symptoms and outcome measures after cognitive behavioral therapy (CBT) intervention.MethodsAdult patients with DM1 were recruited within the OPTIMISTIC trial (NCT02118779). Disease-related history, current clinical symptoms and comorbidities, functional assessments, and disease- and health-related questionnaires were obtained at baseline and after 5 and 10 months. After genetic analysis, we assessed the association between the presence of VR interruptions and clinical symptoms' long-term outcomes and compared the effects of CBT in patients with and without VR interruptions. Core trial outcome measures analyzed were: 6-minute walking test, DM1-Activ-C, Checklist Individual Strength Fatigue Score, Myotonic Dystrophy Health Index, McGill-Pain questionnaire, and Beck Depression inventory—fast screen. Blood samples for DNA testing were obtained at the baseline visit for determining CTG length and detection of VR interruptions.ResultsVR interruptions were detectable in 21/250 patients (8.4%)—12 were assigned to the standard-of-care group (control group) and 9 to the CBT group. Patients with VR interruptions were significantly older when the first medical problem occurred and had a significantly shorter disease duration at baseline. We found a tendency toward a milder disease severity in patients with VR interruptions, especially in ventilation status, mobility, and cardiac symptoms. Changes in clinical outcome measures after CBT were not associated with the presence of VR interruptions.ConclusionsThe presence of VR interruptions is associated with a later onset of the disease and a milder phenotype. However, based on the OPTIMISTIC trial data, the presence of VR interruptions was not associated with significant changes on outcome measures after CBT intervention.Trial Registration InformationClinicalTrials.govNCT02118779.

Objectives: To evaluate the effects of exercise interventions on sleep disturbances and sleep quality in patients with mixed cancer diagnoses, and identify demographic, clinical, and intervention-related moderators of these effects. Methods: Individual patient data (IPD) and aggregated meta-analyses of randomized controlled trials (RCTs). Using data from the Predicting OptimaL cAncer Rehabilitation and Supportive care project, IPD of 2173 adults (mean age = 54.8) with cancer from 17 RCTs were analyzed. A complementary systematic search was conducted (until November 2018) to study the overall effects and test the representativeness of analyzed IPD. Effect sizes of exercise effects on self-reported sleep outcomes were calculated for all included RCTs. Linear mixed-effect models were used to evaluate the effects of exercise on post-intervention outcome values, adjusting for baseline values. Moderator effects were studied by testing interactions for demographic, clinical and intervention-related characteristics. Results: For all 27 eligible RCTs from the updated search, exercise interventions significantly decreased sleep disturbances in adults with cancer (g = -0.09, 95% CI [-0.16; -0.02]). No significant effect was obtained for sleep quality. RCTs included in IPD analyses constituted a representative sample of the published literature. The intervention effects on sleep disturbances were not significantly moderated by any demographic, clinical, or intervention-related factor, nor by sleep disturbances. Conclusions: This meta-analysis provides some evidence that, compared to control conditions, exercise interventions may improve sleep disturbances, but not sleep quality, in cancer patients, although this effect is of a small magnitude. Among the investigated variables, none was found to significantly moderate the effect of exercise interventions on sleep disturbances.

Background Treatment of pituitary pathology mostly does not result in complete recovery of impairment in cognitive functioning. The primary aim of the current study was to assess cognitive impairment in patients with stable replacement therapy for hypopituitarism during the last 6 months prior to inclusion. It was expected that patients showed subjective and objective subnormal scores on neuropsychological functioning. Methods Forty‐two patients (40% men, 49 ± 15 years) treated for hypopituitarism conducted a neuropsychological test battery, including the Cognitive Failures Questionnaire (CFQ), 15‐Word test (15‐WT), Cambridge Neuropsychological Test Automated Battery (CANTAB) Motor Screening Task (MOT), Spatial Working Memory (SWM) and Affective Go/No‐go (AGN). Results were compared to reference values of healthy norm groups. Results Male and female participants scored significantly worse on the CFQ (P, Treatment of pituitary pathology mostly does not result in complete recovery of impairment in cognitive functioning. This study shows that subjective cognitive functioning is worse in patients treated for hypopituitarism compared to reference data. Also, female participants treated for hypopituitarism score worse on objective aspects of memory and executive functioning compared to reference data.

Background: Treatment strategies for childhood cancer are improving, resulting in higher survival rates. However, the consequences of childhood cancer do not end with the successful completion of cancer treatment. Most patients will develop late effects after cessation of treatment. Severe fatigue is seen as a common and debilitating late effect in cancer survivors. Although most research on fatigue has been performed in patients after adult-onset cancer, our review focuses on fatigue after childhood cancer. Objectives: To estimate the prevalence of severe fatigue after treatment for childhood cancer. Secondary objectives are to describe the course of severe fatigue following cancer treatment and to examine risk factors for fatigue, or factors associated with it. Search methods: We searched the Cochrane Central Register of Controlled Trials (the Cochrane Library 2019; issue 8 March 2019), MEDLINE/PubMed (from 1945 to 8 March 2019), Embase/Ovid (from 1947 to 8 March 2019), reference lists of included articles and several conference proceedings from 2011 to 2018. Selection criteria: Observational studies, randomised controlled trials and controlled clinical trials reporting on fatigue in participants after treatment for childhood cancer. Case series and case reports were not eligible for inclusion. Data collection and analysis: Two review authors independently extracted data and assessed risks of bias. If the publication did not present the prevalence of severe fatigue, we contacted study authors for additional information. Main results: We included 30 studies (18,682 participants in total). Eighteen studies contributed to the main objective and 22 studies contributed to the secondary objectives. We found substantial differences between studies in cancer diagnosis, cancer treatment, age of participants, questionnaires used to assess fatigue, and sample size. All included studies scored at least one 'Risk of bias' item as unclear or high risk. We identified both clinical and statistical heterogeneity and therefore could not pool results, so we present them descriptively. Eighteen studies (describing 14,573 survivors) reported the prevalence of severe fatigue, which ranged from 0% to 61.7%. In a subgroup of three studies including children aged up to 18 years at fatigue assessment (268 survivors), prevalence rates ranged from 6.7% to 12.5%. In comparison, in a subgroup of 12 studies including participants aged 16 and over (13,952 survivors), prevalence rates ranged from 4.4% to 61.7%. The prevalence of severe fatigue in a subgroup of survivors of haematological cancer was presented in seven studies and ranged from 1.8% to 35.9% (1907 survivors). Prevalence of severe fatigue in brain cancer survivors was presented in two studies (252 survivors) and was 14.6% and 21.1% respectively. One study presented a prevalence for bone cancer survivors of 0.0% (17 survivors). Four studies provided prevalence rates of severe fatigue in control groups of siblings or population-based controls, which ranged from 3.1% to 10.3%. In these four studies, survivors were more often fatigued than controls, but this difference was statistically significant in only two studies. Studies assessing risk and associated factors for fatigue were heterogeneous, and definitions of the factors under study were often inconsistent, with results therefore presented descriptively. They found that depression might be associated with fatigue. In contrast, age at diagnosis and education level did not seem to be associated with fatigue. We were unable to calculate any overall risk estimate for any of the reported risks and associated factors, because we could not conduct meta-analysis. One study provided information about the course of fatigue over time, and found that over the course of 2.7 years, 32 of the 102 participants (31.4%) reported persistent severe fatigue. Authors' conclusions: It is unclear how many childhood cancer survivors suffer from severe fatigue. This review encountered several difficulties. We found statistical and clinical heterogeneity and great variation in the reporting of possible risk and associated factors. The evidence in this review is therefore weak, and the exact prevalence of severe fatigue after treatment for childhood cancer remains to be determined. This is also the case for the course of severe fatigue following treatment and the strength of the relationship between fatigue and associated and risk factors. Despite these limitations, our review does provide a comprehensive overview of the existing literature about severe fatigue after treatment for childhood cancer.

Performance Validity Tests (PVTs) are used to measure the credibility of neuropsychological test results. Until now, however, a minimal amount is known about the effects of feedback upon noncredible results (i.e., underperformance) on subsequent neuropsychological test performance. The purpose of this study was to investigate the effects of feedback on underperformance in Chronic Fatigue Syndrome (CFS) patients. A subset of these patients received feedback on Amsterdam Short-Term Memory (ASTM) failure (i.e., feedback [FB] group). After matching, the final sample consisted of two comparable groups (i.e., FB and No FB; both n = 33). At baseline and follow-up assessment, the patients completed the ASTM and two measurements of information processing speed (Complex Reaction Time [CRT] and Symbol Digit Test [SDT]). Results indicated that the patients in the FB group improved significantly on the CRT, compared to the No FB group. Although not significant, a comparable trend-like effect was observed for the SDT. Independent of the feedback intervention there was a substantial improvement on ASTM performance at re-administration. A limited feedback intervention upon underperformance in CFS patients may result in improvement on information processing speed performance. This implies that such an intervention might be clinically relevant, since it maximizes the potential of examining the patients' actual level of cognitive abilities.

Contains fulltext : 220990.pdf (Publisher’s version ) (Closed access) PURPOSE: Fatigue is a common and potentially disabling symptom in patients with cancer. It can often be effectively reduced by exercise. Yet, effects of exercise interventions might differ across subgroups. We conducted a meta-analysis using individual patient data of randomized controlled trials (RCT) to investigate moderators of exercise intervention effects on cancer-related fatigue. METHODS: We used individual patient data from 31 exercise RCT worldwide, representing 4366 patients, of whom 3846 had complete fatigue data. We performed a one-step individual patient data meta-analysis, using linear mixed-effect models to analyze the effects of exercise interventions on fatigue (z score) and to identify demographic, clinical, intervention- and exercise-related moderators. Models were adjusted for baseline fatigue and included a random intercept on study level to account for clustering of patients within studies. We identified potential moderators by testing their interaction with group allocation, using a likelihood ratio test. RESULTS: Exercise interventions had statistically significant beneficial effects on fatigue (beta = -0.17; 95% confidence interval [CI], -0.22 to -0.12). There was no evidence of moderation by demographic or clinical characteristics. Supervised exercise interventions had significantly larger effects on fatigue than unsupervised exercise interventions (betadifference = -0.18; 95% CI -0.28 to -0.08). Supervised interventions with a duration

Background Cognitive behavioural therapy (CBT) has been found to be effective in reducing fatigue severity in MS patients directly following treatment. However, long-term effects are inconsistent leaving room for improvement. In addition, individual face-to-face CBT draws heavily on limited treatment capacity, and the travel distance to the treatment centre can be burdensome for patients. Therefore, we developed “MS Fit”, a blended CBT for MS-related fatigue, based on a face-to-face CBT protocol found effective in a previous study, and “MS Stay Fit”, internet-based booster sessions to improve long-term effectiveness of CBT for MS-related fatigue. This article presents the protocol of two randomised clinical trials (RCTs) conducted within one study investigating (1) the non-inferiority of MS Fit compared with evidence-based face-to-face CBT for MS-related fatigue and (2) the effectiveness of MS Stay Fit on the long-term outcome of fatigue compared with no booster sessions. Methods/design The first part of this study is an observer-blinded non-inferiority multicentre RCT, in which 166 severely fatigued MS patients will be randomly assigned (1:1 ratio, computer-generated sequence) to either face-to-face CBT or blended CBT (MS Fit) for fatigue. The primary endpoint is at 20 weeks after baseline. After this post-treatment assessment, patients will be randomly assigned again (1:1 ratio, computer generated sequence) to either MS Stay Fit consisting of two booster sessions at 2 and 4 months after end of treatment or no booster sessions. The primary endpoint of the second study is 52 weeks after baseline. Primary outcome measure in both studies is fatigue severity assessed with the fatigue severity subscale of the Checklist Individual Strength (CIS20r). Outcomes will be assessed at baseline (T0), at the end of treatment (T20), and after 39 and 52 weeks (T39 and T52). Discussion If MS Fit is found to be non-inferior to face-to-face CBT, it will improve the accessibility of this treatment. In addition, the study aims to test whether it is possible to improve long-term effectiveness of CBT for MS-related fatigue with MS Stay Fit. Trial registration Dutch Trial Register (NTR6966), registered 18 January 2018 https://www.trialregister.nl/trial/6782 World Health Organization (WHO) Trial Registration Data Set All items from the WHO Trial Registration Data Set can be found within the protocol.

Background Cancer-related fatigue remains a prevalent and burdensome symptom experienced by patients with advanced cancer. Our aim was to assess the effects of cognitive behavioral therapy (CBT) or graded exercise therapy (GET) on fatigue in patients with advanced cancer during treatment with palliative intent. Patients and methods A randomized controlled trial was conducted from 1 January 2013 to 1 September 2017. Adult patients with locally advanced or metastatic cancer who reported severe fatigue during treatment [Checklist Individual Strength, subscale fatigue severity (CIS-fatigue) ≥35] were accrued across nine centers in The Netherlands. Patients were randomly assigned to either 12 weeks of CBT or GET, or usual care (1 : 1: 1, computer-generated sequence). Primary outcome was CIS-fatigue at 14 weeks. Secondary outcomes included fatigue measured with the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ-C30), quality of life, emotional functioning, physical functioning, and functional impairments at baseline, 14, 18, and 26 weeks. Results Among 134 participants randomized, the mean age was 63 (standard deviation 9) years and 77 (57%) were women. Common diagnoses included: breast (41%), colorectal (28%), and prostate cancer (17%). A total of 126 participants completed assessment at 14 weeks. Compared with usual care, CBT significantly reduced fatigue [difference −7.2, 97.5% confidence interval (CI) −12.7 to −1.7; P = 0.003, d = 0.7], whereas GET did not (−4.7, 97.5% CI −10.2 to 0.9; P = 0.057, d = 0.4). CBT significantly reduced EORTC-QLQ-C30 fatigue (−13.1, 95% CI −22.1 to −4.0; P = 0.005) and improved quality of life (10.2, 95% CI 2.4 to 17.9; P = 0.011) and physical functioning (7.1, 95% CI 0.5 to 13.7; P = 0.036) compared with usual care. Improvement in emotional functioning and decrease in functional impairments failed to reach significance. GET did not improve secondary outcomes compared with usual care. Conclusions Among advanced cancer patients with severe fatigue during treatment, a CBT intervention was more effective than usual care for reducing fatigue. Following GET, patients reported lower fatigue, but results were not significant, probably due to a smaller sample size and lower adherence than anticipated. Trial Registration Netherlands National Trial Register, identifier: NTR3812.

Contains fulltext : 225951.pdf (Publisher’s version ) (Closed access) PURPOSE: This study evaluated the effects of coping skills training (CST) on symptoms of depression and anxiety in cancer patients, and investigated moderators of the effects. METHODS: Overall effects and intervention-related moderators were studied in meta-analyses of pooled aggregate data from 38 randomized controlled trials (RCTs). Patient-related moderators were examined using linear mixed-effect models with interaction tests on pooled individual patient data (n = 1953) from 15 of the RCTs. RESULTS: CST had a statistically significant but small effect on depression (g = -0.31,95% confidence interval (CI) = -0.40;-0.22) and anxiety (g = -0.32,95%CI = -0.41;-0.24) symptoms. Effects on depression symptoms were significantly larger for interventions delivered face-to-face (p = .003), led by a psychologist (p = .02) and targeted to patients with psychological distress (p = .002). Significantly larger reductions in anxiety symptoms were found in younger patients (p(interaction)

Objective. To determine psychometric properties, a cut-off score for severe fatigue and normative data for the 4-item Short Fatigue Questionnaire (SFQ) derived from the multi-dimensional fatigue questionnaire Checklist Individual Strength (CIS). Methods. Data of previous studies investigating the prevalence of fatigue in ten chronic conditions (n = 2985) and the general population (n = 2288) was used to determine the internal consistency (Cronbach's alpha) of the SFQ, its relation with other fatigue measures (EORTC QLQ-30 fatigue subscale and digital fatigue diary), a cut-off score for severe fatigue (ROC analysis) and to examine whether the four SFQ items truly measure the same construct. Norms were calculated for ten patient groups and the Dutch general population. Results. Cronbach's alpha of the SFQ were excellent in almost all groups. Pearson's correlations between the SFQ and the EORTC-QLQ-C30 fatigue subscale and a fatigue diary were respectively 0.76 and 0.68. ROC analysis showed an area under the curve of 0.982 (95% CI: 0.979–0.985) and cut-off score of 18 was suggested which showed a good sensitivity (0.984) and specificity (0.826) as well as excellent values for the positive and negative prediction values within all groups using the CIS as golden standard. Factor analysis showed a one factor solution (Eigenvalue: 3.095) with factor loadings of all items on the factor being greater than 0.87. Conclusion. The SFQ is an easy to use, reliable and valid instrument to screen for severe fatigue in clinical routine and research.

Exercise effects in cancer patients often appear modest, possibly because interventions rarely target patients most in need. This study investigated the moderator effects of baseline values on the exercise outcomes of fatigue, aerobic fitness, muscle strength, quality of life (QoL), and self-reported physical function (PF) in cancer patients during and post-treatment. Methods: Individual patient data from 34 randomized exercise trials (n = 4519) were pooled. Linear mixed-effect models were used to study moderator effects of baseline values on exercise intervention outcomes and to determine whether these moderator effects differed by intervention timing (during vs post-treatment). All statistical tests were two-sided. Results: Moderator effects of baseline fatigue and PF were consistent across intervention timing, with greater effects in patients with worse fatigue (Pinteraction = .05) and worse PF (Pinteraction = .003). Moderator effects of baseline aerobic fitness, muscle strength, and QoL differed by intervention timing. During treatment, effects on aerobic fitness were greater for patients with better baseline aerobic fitness (Pinteraction = .002). Post-treatment, effects on upper (Pinteraction < .001) and lower (Pinteraction = .01) body muscle strength and QoL (Pinteraction < .001) were greater in patients with worse baseline values. Conclusion: Although exercise should be encouraged for most cancer patients during and post-treatments, targeting specific subgroups may be especially beneficial and cost effective. For fatigue and PF, interventions during and post-treatment should target patients with high fatigue and low PF. During treatment, patients experience benefit for muscle strength and QoL regardless of baseline values; however, only patients with low baseline values benefit post-treatment. For aerobic fitness, patients with low baseline values do not appear to benefit from exercise during treatment. Sin financiación 13.757 JCR (2018) Q1, 6/196 Oncology 5.827 SJR (2018) Q1, 6/226 Cancer Research, 10/381 Oncology No data IDR 2018 UEM

Introduction Internet-based cognitive behavioural therapy (ICBT) for chronic pain and chronic fatigue syndrome (CFS) has a high potential to increase the number of patients who can receive an evidence based treatment aimed to reduce symptoms and/or disability and to lower burden on (mental) health care. However, implementing a new behaviour-change intervention, and especially an online intervention, has shown to be a challenge. This study aimed to identify factors influencing the implementation process of ICBT for chronic pain and CFS in mental health care. Methods A qualitative study using semi-structured interviews with therapists and managers from twelve mental health care clinics was conducted. Questions and analysis were guided by the Consolidated Framework for Implementation Research (CFIR), covering five domains: (1) the implemented intervention, (2) individual characteristics of the users, (3) the inner setting of implementation, (4) the outer setting, and (5) the implementation process. Results In all five domains important facilitators and barriers were found. Key themes were: (1) the quality of the content, its perceived effectiveness and usability, (2) the attitude, self-efficacy and ability to learn new skills among therapists, and motivation to start online treatment among patients, (3) internal communication within a team, existing workload, and top-down support from the management, (4) availability of reimbursement options and marketing strategies, and (5) involvement of all key stakeholders, steering towards independence of the implementation sites during the process and adequate training of therapists. Conclusions This study provides insight in the challenge of implementing ICBT for chronic pain and CFS in daily clinical practice. Several lessons can be learned from the interviews with therapists and managers which can also be more broadly applied to (ICBT) implementation projects in general. Development of practical tools to support the implementation process would be a valuable next step to overcome certain challenges at forehand and to properly prepare for those expected to come along., Highlights • ICBT for chronic somatic conditions such as pain and fatigue can increase access to evidence-based psychological care • Implementing ICBT in mental health care has been found to be challenging on many levels • Implementation of ICBT for chronic pain and fatigue was evaluated with the Consolidated Framework for Implementation Research • Therapists and managers interviews gave a thorough insight in factors influencing the adoption of ICBT in daily clinical care • Key factors were ‘gain all stakeholders' support’, ‘align goals, expectations and skills’, and ‘create a sense of ownership’

Treatment-related fatigue significantly limits quality of life among chronic myeloid leukemia (CML) patients receiving tyrosine kinase inhibitors (TKIs), yet no interventions to reduce this symptom have been studied. We examined preliminary feasibility and efficacy of cognitive behavioral therapy for TKI treatment-related fatigue in patients with CML. We used a mixed methods convergent design and collected quantitative data through randomized single-case experiments. We included CML patients receiving TKIs and reporting severe fatigue. Within each participant, we compared CBT to a no-treatment baseline period. Fatigue severity was measured weekly with the Checklist Individual Strength. Fatigue scores were subjected to visual analyses and randomization tests for single-case experimental designs. We conducted qualitative interviews after study participation and focused on feasibility and efficacy of CBT. Visual inspection of line graphs indicated downward trends in the expected direction for fatigue in two of the four participants. The test statistics showed a decrease in fatigue severity for all participants but randomization tests did not reach statistical significance (overall p = 0.18). Participants reported qualitative improvements in level of functioning and coping with fatigue. CBT was considered feasible and acceptable for severely fatigued CML patients. Our study provided preliminary evidence for the feasibility and acceptability of CBT for severely fatigued CML patients receiving targeted therapy. We recommend further efficacy testing of this promising intervention in a pilot randomized controlled trial. ispartof: Journal of Clinical Psychology in Medical Settings vol:26 issue:4 pages:440-448 ispartof: location:United States status: published

Contains fulltext : 190935.pdf (Publisher’s version ) (Closed access) BACKGROUND: Cognitive behavioural therapy (CBT) effectively reduces fatigue directly following treatment in patients with Multiple Sclerosis (MS), but little is known about the process of change during and after CBT. DESIGN: Additional analysis of a randomized clinical trial. OBJECTIVE: To investigate which psychological factors mediate change in fatigue during and after CBT. METHODS: TREFAMS-CBT studied the effectiveness of a 16-week CBT treatment for MS-related fatigue. Ninety-one patients were randomized (44 to CBT, 47 to the MS-nurse consultations). Mediation during CBT treatment was studied using assessments at baseline, 8 and 16weeks. Mediation of the change in fatigue from post-treatment to follow-up was studied separately using assessments at 16, 26 and 52weeks. Proposed mediators were: changes in illness cognitions, general self-efficacy, coping styles, daytime sleepiness, concentration and physical activity, fear of disease progression, fatigue perceptions, depression and physical functioning. Mediators were separately analysed according to the product-of-coefficients approach. Confidence intervals were calculated with a bootstrap procedure. RESULTS: During treatment the decrease in fatigue brought on by CBT was mediated by improved fatigue perceptions, increased physical activity, less sleepiness, less helplessness, and improved physical functioning. Post-treatment increases in fatigue levels were mediated by reduced physical activity, reduced concentration, and increased sleepiness. CONCLUSION: These results suggests that focusing on improving fatigue perceptions, perceived physical activity, daytime sleepiness, helplessness, and physical functioning may further improve the effectiveness of CBT for fatigue in patients with MS. Maintenance of treatment effects may be obtained by focusing on improving physical activity, concentration and sleepiness.

Background - Fatigue is one of the most common and disabling complaints in patients with breast cancer and can effectively be reduced by physical exercise, with small to moderate effect sizes. To identify heterogeneity in responses to exercise and to further personalize exercise prescriptions, moderators of exercise effects on fatigue should be investigated. However, most randomized controlled trials (RCTs) are not adequately powered for such analyses. Therefore we conducted meta-analyses using the individual patient data of several exercise RCTs. The aim is to investigate the effect and moderators of physical exercise on cancer-related fatigue in patients with breast cancer. Methods - Within the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) consortium, principal investigators of 34 exercise RCTs worldwide have shared their individual patient data. Twenty-two of these RCTs included patients with breast cancer with a total sample size of 3,061. Different questionnaires to assess level of fatigue were used, which was acknowledged by using z-scores in the analysis. A one-step individual patient data meta-analysis, using a linear mixed-effect model adjusted for baseline fatigue, with a random intercept on study (to account for study clustering) was undertaken to investigate effect of exercise on fatigue. The result, a between-group difference in z-scores, corresponds to a Cohen's d effect size. An interaction term was included in the model to assess potential moderators including demographic (age, marital status, education), clinical (body mass index, presence of distant metastasis), intervention-related (intervention timing, delivery mode and duration), and exercise-related (exercise type, frequency, intensity, duration) characteristics. Results – Exercise significantly reduced fatigue reported by women with breast cancer (β= -0.15, 95% CI -0.21;-0.09). This effect did not differ significantly between patients with different demographic and clinical characteristics (p-valuesinteraction >0.05). Also, neither timing (during or post-treatment) and duration of the intervention, nor exercise-related factors moderated intervention effects on fatigue. Supervised exercise had significantly larger effects on fatigue than unsupervised exercise (βdifference= -0.17, 95%CI -0.28;-0.05). Compared to the control group, supervised exercise significantly improved fatigue (β = -0.21, 95%CI = -0.28;-0.14), while unsupervised exercise did not (β = -0.04, 95%CI = -0.14;0.06). Conclusion – Exercise significantly reduces fatigue in patients with breast cancer across subgroups formed on the basis of age, marital status, education level, body mass index, and presence of distant metastasis. The effect of exercise is significantly larger when performed under supervision. Hence, exercise, and preferably supervised exercise, represents a viable intervention for the prevention and treatment of fatigue among patients with breast cancer. Citation Format: van Vulpen JK, Sweegers MG, Kalter J, Peeters PH, Courneya KS, Newton RU, Aaronson NK, Jacobsen PB, Steindorf K, Stuiver MM, Hayes S, Mesters I, Knoop H, Goedendorp M, Mutrie N, Thorsen L, Schmidt M, Sonke GS, Bohus M, James EL, Oldenburg HS, Velthuis MJ, Nollet F, Wenzel J, Wiskemann J, Galvão DA, Chinapaw MJ, Irwin ML, Griffith KA, van Weert E, Daley AJ, McConnachie A, Schulz K-H, Short CE, Plotnikoff RC, Potthoff K, van Beurden M, van Harten WH, Schmitz KH, Winters-Stone KM, Taaffe DR, van Mechelen W, Kersten M-J, Verdonck-de Leeuw IM, Brug J, Buffart LM, May AM. Effect and moderators of exercise on fatigue in patients with breast cancer: Meta-analysis of individual patient data [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-12-06.

Contains fulltext : 190934.pdf (Publisher’s version ) (Open Access) OBJECTIVE: We previously described symptom-based chronic fatigue syndrome (CFS/ME) phenotypes in clinical assessment data from 7041 UK and 1392 Dutch adult CFS/ME patients. Here we aim to replicate these phenotypes in a more recent UK patient cohort, and investigate whether phenotypes are associated with 1-year treatment outcome. METHODS: 12 specialist CFS/ME services (11 UK, 1 NL) recorded the presence/absence of 5 symptoms (muscle pain, joint pain, headache, sore throat, and painful lymph nodes) which can occur in addition to the 3 symptoms (post-exertional malaise, cognitive dysfunction, and disturbed/unrefreshing sleep) that are present for almost all patients. Latent Class Analysis (LCA) was used to assign symptom profiles (phenotypes). Multinomial logistic regression models were fitted to quantify associations between phenotypes and overall change in health 1year after the start of treatment. RESULTS: Baseline data were available for N=918 UK and N=1392 Dutch patients, of whom 416 (45.3%) and 912 (65.5%) had 1-year follow-up data, respectively. 3- and 4-class phenotypes identified in the previous UK patient cohort were replicated in the new UK cohort. UK patients who presented with 'polysymptomatic' and 'pain-only' phenotypes were 57% and 67% less likely (multinomial odds ratio (MOR) 0.43 (95% CI 0.19-0.94) and 0.33 (95% CI 0.13-0.84)) to report that their health was "very much better" or "much better" than patients who presented with an 'oligosymptomatic' phenotype. For Dutch patients, polysymptomatic and pain-only phenotypes were associated with 72% and 55% lower odds of improvement (MOR 0.28 (95% CI 0.11, 0.69) and 0.45 (95% CI 0.21, 0.99)) compared with oligosymptomatic patients. CONCLUSIONS: Adult CFS/ME patients with multiple symptoms or pain symptoms who present for specialist treatment are much less likely to report favourable treatment outcomes than patients who present with few symptoms.

Objective: Severe fatigue is highly prevalent in various chronic diseases. Disease-specific fatigue models have been developed, but it is possible that fatigue-related factors in these models are similar across diseases. The purpose of the current study was to determine the amount of variance in fatigue severity explained by: (a) the specific disease, (b) factors associated with fatigue across different chronic diseases (transdiagnostic factors), and (c) the interactions between these factors and specific diseases. Method: Data from 15 studies that included 1696 patients with common chronic diseases and disorders that cause long-term disabilities were analyzed. Linear regression analysis with the generalized least-squares technique was used to determine fatigue-related factors associated with fatigue severity, that is, demographic variables, health-related symptoms and psychosocial variables. Results: Type of chronic disease explained 11% of the variance noted in fatigue severity. The explained variance increased to 55% when the transdiagnostic factors were added to the model. These factors were female sex, age, motivational and concentration problems, pain, sleep disturbances, physical functioning, reduced activity and lower self-efficacy concerning fatigue. The predicted variance increased to 61% when interaction terms were added. Analysis of the interactions revealed that the relationship between fatigue severity and relevant predictors mainly differed in strength, not in direction. Conclusions: Fatigue severity can largely be explained by transdiagnostic factors; the associations vary between chronic diseases in strength and significance. This suggests that severely fatigued patients with different chronic diseases can probably benefit from a transdiagnostic fatigue-approach which focuses on individual patient needs rather than a specific disease.

BackgroundFace-to-face cognitive–behavioural therapy (CBT) leads to a reduction of fatigue in chronic fatigue syndrome (CFS).AimsTo test the efficacy of internet-based CBT (iCBT) for adults with CFS.MethodA total of 240 patients with CFS were randomised to either iCBT with protocol-driven therapist feedback or with therapist feedback on demand, or a waiting list. Primary outcome was fatigue severity assessed with the Checklist Individual Strength (Netherlands Trial Register: NTR4013).ResultsCompared with a waiting list, intention-to-treat (ITT) analysis showed a significant reduction of fatigue for both iCBT conditions (protocol-driven feedback: B = −8.3, 97.5% CI −12.7 to −3.9, P < 0.0001; feedback on demand: B = −7.2, 97.5% CI −11.3 to –3.1, P < 0.0001). No significant differences were found between both iCBT conditions on all outcome measures (P = 0.3–0.9). An exploratory analysis revealed that feedback-on-demand iCBT required less therapist time (mean 4 h 37 min) than iCBT with protocol-driven feedback (mean 6 h 9 min, P < 0.001) and also less than face-to-face CBT as reported in the literature.ConclusionsBoth iCBT conditions are efficacious and time efficient.Declaration of interestNone.

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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.