Fatigue Self-efficacy Research Articles

Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue

ObjectivePoly(ADP-ribose) polymerase inhibitors (PARPi) have dramatically changed treatment for advanced ovarian cancer, but nearly half of patients experience significant fatigue. We conducted a two-site pilot randomized trial to evaluate the feasibility, acceptability, and preliminary efficacy of a brief, acceptance-based telehealth intervention (REVITALIZE) designed to reduce fatigue interference in patients on PARPi. MethodsFrom June 2021 to April 2022, 44 participants were randomized 1:1 to REVITALIZE (6 weekly one-on-one sessions+booster) or enhanced usual care. Feasibility was defined as: ≥50% approach-to-consent among potentially eligible patients and ≥70% completion of 12-week follow-up assessment; acceptance was <20% participants reporting burden and <20% study withdrawal. Fatigue, anxiety, depression, and quality of life were assessed at baseline, 4-, 8- and 12-weeks. ResultsAmong 44 participants (mean age = 62.5 years, 81.8% stage III/IV disease), the study was feasible (56.4% approach-to-consent ratio, 86.3% completion of 12-week assessment) and acceptable (0% reporting burden, 11.3% study withdrawal). At 12-week follow-up, REVITALIZE significantly reduced fatigue interference (Cohen's d = 0.94, p = .008) and fatigue severity (d = 0.54, p = .049), and improved fatigue levels (d = 0.62, p = .04) relative to enhanced usual care. REVITALIZE also showed promise for improved fatigue self-efficacy, fatigue catastrophizing, anxiety, depression, and quality of life (ds = 0.60–0.86, p ≥ .05). Compared with enhanced usual care, REVITALIZE participants had fewer PARPi dose reductions (6.7% vs. 19.0%), and dose delays (6.7% vs. 23.8%). ConclusionsAmong fatigued adults with ovarian cancer on PARPi, a brief, acceptance-based telehealth intervention was feasible, acceptable, and demonstrated preliminary efficacy in improving fatigue interference, severity, and levels. REVITALIZE is a novel, scalable telehealth intervention worthy of further investigation.

Pilot randomized trial of a telehealth intervention for women with advanced ovarian cancer and PARP inhibitor-related fatigue.

e24122 Background: Poly(ADP-ribose) polymerase inhibitors (PARPi) have dramatically changed the treatment of advanced ovarian cancer and are increasingly used in other cancers. However, PARPi cause significant fatigue in nearly half of patients. Psychosocial interventions have shown promise for treating cancer-related fatigue, but there is limited evidence for use in patients with advanced cancers. Moreover, most fatigue interventions have been delivered in person over many sessions, limiting their accessibility and scalability. Methods: We conducted a pilot randomized trial of REVITALIZE, a 6-session telehealth intervention developed and refined by our group, compared with enhanced usual care among 35 fatigued patients with advanced or recurrent ovarian cancer on PARPi at two sites, Dana-Farber Cancer Institute and University of Pennsylvania. REVITALIZE was based on acceptance and commitment-based behavioral therapy and addressed modifiable contributors to PARPi-related fatigue. The trial tested the feasibility, acceptability, and preliminary efficacy of REVITALIZE through 3-month follow-up. Exit interviews were conducted with all REVITALIZE patients. Results: Among 35 participants (mean age=62.5 years, 83% stage III/IV disease, 46% first-line maintenance therapy), the trial met or exceeded its acceptability and feasibility goals. Exit interviews further indicated high acceptability. Relative to enhanced usual care, REVITALIZE significantly reduced fatigue interference at 12-week follow-up (Cohen’s d=.94, p=.008) and fatigue severity (d=.54, p=.049), while improving current fatigue levels (d=.62, p=0.04). REVITALIZE participants also reported improved fatigue self-efficacy, fatigue catastrophizing, depression, anxiety, and quality of life (ds=.60-.86). REVITALIZE participants were also numerically less likely to experience PARPi dose reductions compared with enhanced usual care (7% vs. 17%), and less likely to have dose delays (7% vs. 22%). Conclusions: Among fatigued adults with advanced ovarian cancer on PARPi, a brief telehealth intervention based on acceptance and commitment therapy showed strong feasibility, acceptability, and preliminary efficacy with improvements in fatigue, anxiety, depression, and quality of life outcomes. REVITALIZE is a novel, scalable telehealth intervention worthy of further investigation in patients with advanced cancers with PARPi-related fatigue. The study is supported by the National Comprehensive Cancer Network (NCCN) through a grant provided by AstraZeneca. Neither NCCN or AstraZeneca are the sponsors of this study. Clinical trial information: NCT04525183 .

Effect of multidisciplinary interventions on the quality of life of individuals with multiple sclerosis: a systematic review

Introduction: The study aims to review published literature on multidisciplinary interventions and their effect on quality of life of individuals with multiple sclerosis to produce state-of-the-art recommendations and consistent discipline combinations for optimal holistic patient car Methods: The study thoroughly analyzed papers published between January 2010 and February 2022. The publications are gathered from five critical databases: Cochrane, JSTOR, PEDro, PubMed, and ScienceDirect. With Rayyan, the data is analyzed. Independent reviewers evaluate the quality of the papers included in the review using the PEDro Scale and the Cochrane Collaboration tool. Results: The review includes ten studies with an average of 129 participants for each of the 513 identified articles. In QOL domains, multidisciplinary rehabilitation programs address limits in physical role (p = 0.016), emotional role (p = 0.010), mental wellbeing composite (p = 0.017), and cardiorespiratory fitness (p = 0.017). In addition, it improves Fatigue, as measured by the Chalder Fatigue Scale, the SF-36 vitality subscale, and Fatigue self-efficacy. Only one study found no statistically significant differences in its primary outcome. With 19 individuals, the Level of Activity improved, notably the Timed 50 Meter Walk (p = 0.014), walking speed (p = 0.034), 2- (p = 0.204), and 6-Minute Walk (p = 0.027). Discussion: In terms of quality of life and decrease in fatigue, multidisciplinary interventions have a remarkable impact on the activity level of MS patients. Findings suggest that Multidisciplinary interventions and other treatment combinations are best recommended in patients with MS to improve multicomponents of QoL and different outcomes such as fatigue.

Condition or cognition? Mechanism of change in fatigue in a randomized controlled trial of graded exercise therapy or cognitive behavior therapy for severe fatigue in patients with advanced cancer.

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. 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. 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. 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).

Benefits of a program associating exercise therapy and therapeutic education on fatigue in multiple sclerosis

Literature findings have proven the efficacy of exercise training on fatigue symptoms in multiple sclerosis (MS). Other studies showed a benefit of educational programs on fatigue management in MS. A 2-week hospital-based rehabilitation program associating both of these aspects was created in 2016. The aim of this study was to analyze the efficacy of this program. Pre- and post-prospective observational study of patients with MS of EDSS below 7 presenting with disabling fatigue. Patients were evaluated before and 3 months after the program. Assessments included the 6-min walking test, the maximal oxygen uptake (VO 2 max) in a cycling exercise test, the numerical scale (NS) of fatigue, the Multiple Sclerosis Fatigue Self-Efficacy Scale (MSFSE, max = 100), which assesses patients’ subjective feeling of self-efficacy to manage their fatigue, and level of weekly sport or physical activity. Twenty-seven patients completed the program and 17 received the 3-month assessment (10 evaluation pending). Mean age was 43, mean EDSS was 3.4. Among the 17 patients, 5 suffered a relapse of MS before the 3-months follow-up. Mean 6-minutes walking distance was 398 ± 73 m pre-program and 407 ± 87 m at 3 months. Mean VO 2 max before was 71 ± 24% and 76 ± 24% after. VO 2 max increased for 78% of patients ( n = 9). Mean fatigue NS remained stable at 5/10. Mean MSFSE score increased from 56 ± 20 to 75 ± 25. Among patients who had no physical activity before the program, 75% had started a regular activity, which was maintained at 3 months. Among patients who had a previous physical activity, 44% increased their activity level. This 2-week program including education and exercise training did not seem to modify walking ability and fatigue, but patients improved their physical activity and their feeling of self-efficacy. It thus appeared that the educational aspects of the program were the most beneficial on the long term.

A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial.

PurposeCancer-related fatigue (CRF) is a frequent and distressing symptom experienced after cancer treatment. RESTORE is the first web-based resource designed to enhance self-efficacy to manage CRF following curative-intent treatment. The aim of this study is to test the proof of concept and inform the design of an effectiveness trial.MethodsA multi-centre parallel-group two-armed (1:1) exploratory randomised controlled trial (RCT) with qualitative process evaluation was employed in the study. Participants (≥18 years; ≤5 years post treatment with moderate to severe fatigue) were recruited and randomly assigned to RESTORE or a leaflet. Feasibility and acceptability were measured by recruitment, attrition, intervention adherence, completion of outcome measures and process evaluation. Change in self-efficacy to manage CRF was also explored. Outcome measures were completed at baseline (T0), 6 weeks (T1) and 12 weeks (T2). Data were analysed using mixed-effects linear regression and directed content analysis.ResultsOne hundred and sixty-three people participated in the trial and 19 in the process evaluation. The intervention was feasible (39 % of eligible patients consented) and acceptable (attrition rate 36 %). There was evidence of higher fatigue self-efficacy at T1 in the intervention group vs comparator (mean difference 0.51 [−0.08 to 1.11]), though the difference in groups decreased by 12 weeks. Time since diagnosis influenced perceived usefulness of the intervention. Modifications were suggested.ConclusionProof of concept was achieved. The RESTORE intervention should be subject to a definitive trial with some adjustments. Provision of an effective supportive resource would empower cancer survivors to manage CRF after treatment completion.Trial registrationISRCTN67521059

Management of cancer-related fatigue during chemotherapy through telephone motivational interviewing: Modeling and randomized exploratory trial

ObjectiveFatigue is a common cancer-related symptom and exacerbated by chemotherapy. Psychological interventions for fatigue show promise. One, Beating Fatigue, was adapted for delivery by telephone and evaluated in an exploratory trial. MethodsEight patients and 12 professionals contributed to focus groups that guided adaptation of the intervention. The intervention, modified for delivery by telephone using motivational interviewing, was tested in an exploratory trial. Forty-four patients were recruited to the trial and randomized between the intervention (n=23) and control (n=21). Outcome data were collected on fatigue intensity, fatigue distress, fatigue self-efficacy, anxiety and depression at baseline and following completion of chemotherapy. These data were augmented by interviews conducted to inform understanding of the intervention's mechanism, feasibility and acceptability. ResultsThe intervention was both feasible and acceptable to patients and most reduced fatigue distress (Effect Size ES=0.62). It also reduced fatigue intensity (ES=0.18), fatigue self-efficacy (ES=−0.34), and anxiety (ES=0.31). It did not reduce depression. ConclusionThese preliminary data are encouraging and support the delivery of interventions for cancer-related fatigue by telephone. Motivational interviewing appeared key to the intervention's success. A larger definitive RCT is indicated.Practice Implications: Opportunities should be sought to deliver psychologically-based interventions for fatigue by telephone.

A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis

BackgroundFatigue is a common and troubling symptom for people with multiple sclerosis (MS).AimTo evaluate the effectiveness and cost-effectiveness of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural...

134 Group-based cognitive behavioural approach to managing fatigue in multiple sclerosis is effective: a multi-centre parallel arm randomised controlled trial

AimFatigue is one of the most commonly reported symptoms of MS. This trial evaluates the clinical effectiveness of a group-based fatigue management intervention for people with MS.Study designPragmatic multi-centre parallel...