Dataset Information

Tailored exercise interventions to reduce fatigue in cancer survivors: study protocol of a randomized controlled trial.

ABSTRACT:

Background

Cancer-related fatigue (CRF) is a common and distressing symptom of cancer and/or cancer treatment that persists for years after treatment completion in approximately one third of cancer survivors. Exercise is beneficial for the management of CRF, and general exercise guidelines for cancer survivors are available. There are multiple potential pathways by which exercise improves CRF, and cancer survivors with CRF are diverse with respect to cancer type, treatments and experienced side effects. While the general exercise guidelines are likely sufficient for most cancer survivors, tailoring of exercise interventions may be more effective in those with persistent fatigue. The primary aim of this research is to investigate the effect of a traditional vs. tailored exercise intervention on CRF severity in cancer survivors with persistent CRF.

Methods/design

Cancer survivors (? 3 months and???5 years since primary treatment) who score???34 on the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) will be randomly allocated to one of two parallel treatment arms: traditional (active control) and tailored exercise. Participants in the traditional exercise group will engage in aerobic and resistance exercise that is consistent with exercise guidelines for cancer survivors. The tailored exercise group will be prescribed an intervention designed to address individual deficits identified at baseline, such as loss of muscular strength, cardiorespiratory deconditioning or sleep disturbance. Participants will be assessed before and after the intervention for CRF severity and other patient-reported outcomes, neuromuscular function and fatigue in response to whole-body exercise, sleep quantity and quality, physical activity levels, cardiorespiratory fitness and blood biomarkers.

Discussion

To our knowledge, this will be the first study to compare the effects of a traditional vs. tailored exercise intervention on CRF severity in cancer survivors with persistent CRF. Using physiological, behavioural and patient-reported outcomes, this study will add to the current knowledge about both the factors contributing to CRF, and the potential reduction in CRF severity with an exercise intervention.

Trial registration

The study is registered at ClinicalTrials.gov ( NCT03049384 ), February, 2017.

SUBMITTER: Twomey R

PROVIDER: S-EPMC6057053 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Publications

Tailored exercise interventions to reduce fatigue in cancer survivors: study protocol of a randomized controlled trial.

Twomey Rosie R Martin Tristan T Temesi John J Culos-Reed S Nicole SN Millet Guillaume Y GY

BMC cancer 20180724 1

<h4>Background</h4>Cancer-related fatigue (CRF) is a common and distressing symptom of cancer and/or cancer treatment that persists for years after treatment completion in approximately one third of cancer survivors. Exercise is beneficial for the management of CRF, and general exercise guidelines for cancer survivors are available. There are multiple potential pathways by which exercise improves CRF, and cancer survivors with CRF are diverse with respect to cancer type, treatments and experienc ...[more]

PMID: 30041626

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Project description:BackgroundPeer-based exercise interventions that cultivate new opportunities for support with a fellow cancer survivor may result in increased exercise volume. It is not clear whether adding qualified exercise professional (QEP) support to peer-based interventions improves health outcomes. Therefore, the purpose of this study is to determine whether breast cancer survivor (BCS) dyads who receive 10 weekly sessions of virtually delivered QEP support have improved outcomes compared to BCS dyads who do not receive QEP support.MethodsParticipants Adult BCS with medical clearance for exercise, who have an internet-connected device, and currently engage in < 150 min of moderate-intensity exercise per week. Intervention BCS will be matched using evidence-based criteria. The intervention group will receive dyadic exercise information sessions and a program tailored by a QEP for 10 weeks (intervention period) and have access to the QEP for an additional 4 weeks (tapering period). The control will not receive any QEP support. Outcomes The primary outcome is post-intervention self-reported exercise volume. Secondary outcomes include device-assessed exercise volume (i.e., Fitbit), social support, and health-related quality of life. Randomization 108 participants, matched in dyads, will be randomized 1:1 to the MatchQEP or Match groups using a web-based scheme. Statistical analysis Outcomes will be measured at baseline, post-intervention, post-tapering, and at 12 weeks post-intervention follow-up.DiscussionThe findings from this RCT will determine if matched BCS dyads who receive 10 weeks of virtually delivered QEP support have higher levels of self-report and device-measured exercise, social support, and health related quality of life compared to matched dyads without QEP-delivered exercise guidance. To our knowledge this will be the first study to assess the combined effect of peer- and QEP support on exercise volume. Project findings will inform and optimize intervention methods aimed to increase exercise among BCS through accessible exercise supports.Trial Registration: The study is registered on ClinicalTrials.gov (study identifier: NCT04771975, protocol Version Number: 2, date: July 22, 2021).Supplementary informationThe online version contains supplementary material available at 10.1186/s13102-021-00341-w.

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Project description:BackgroundMany university students experience high levels of study-related fatigue. This high prevalence, and the negative impact of fatigue on health and academic performance, call for prevention and reduction of these symptoms. The primary aim of the current study was to investigate to what extent an exercise intervention is effective in reducing three indicators of study-related fatigue (emotional exhaustion, overall fatigue, and need for recovery). Effects of exercise on secondary outcomes (sleep quality, self-efficacy, physical fitness, and cognitive functioning) were also investigated.MethodsParticipants were students with high levels of study-related fatigue, currently not exercising or receiving other psychological or pharmacological treatments, and with no medical cause of fatigue. They were randomly assigned to either a six-week exercise intervention (low-intensity running three times a week, n = 49) or wait list (no intervention, n = 48). All participants were measured before the intervention (T0), and immediately after the intervention (T1). Exercisers were also investigated 4 weeks (T2) and 12 weeks (T3) after the intervention.ResultsParticipants in the exercise condition showed a larger decrease in two of the three indicators of study-related fatigue (i.e., overall fatigue and need for recovery) as compared to controls. Additionally, sleep quality and some indicators of cognitive functioning improved more among exercisers than among controls. No effects were found for self-efficacy, and physical fitness. The initial effects of the exercise intervention lasted at follow-up (T2 and T3). At 12-week follow up (T3), 80% of participants in the exercise condition still engaged in regular exercise, and further enhancements were seen for emotional exhaustion, overall fatigue, and sleep quality.ConclusionsThese results underline the value of low-intensity exercise for university students with high levels of study-related fatigue. The follow-up effects that were found in this study imply that the intervention has the potential to promote regular exercise and accompanying beneficial effects in the longer run.Trial registrationNetherlands Trial Register NTR4412.

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Project description:BACKGROUND:Cancer related fatigue (CRF) is one of the most prevalent and distressing long-term complaints reported by (non-) Hodgkin survivors. To date there has been no standard treatment for CRF in this population. A novel and promising approach to treat CRF is exposure to bright white light therapy. Yet, large scale randomized controlled trials testing its efficacy in these patients and research on potential mechanisms is lacking. The objective of the current study is to investigate the efficacy of light therapy as a treatment for CRF and to explore potential mechanisms. METHODS/DESIGN:In a multicenter, randomized controlled trial we are evaluating the efficacy of two intensities of light therapy in reducing CRF complaints and restrictions caused by CRF in survivors of Hodgkin lymphoma or diffuse large B-cell lymphoma. Secondary outcomes include sleep quality, depression, anxiety, quality of life, cognitive complaints, cancer worries, fatigue catastrophizing, self-efficacy to handle fatigue, biological circadian rhythms of melatonin, cortisol and activity, and biomarkers of inflammation. We will recruit 128 survivors, with fatigue complaints, from academic and general hospitals. Survivors are randomized to either an intervention (exposure to bright white light) or a comparison group (exposure to dim white light). The longitudinal design includes four measurement points at baseline (T0), post-intervention at 3.5 weeks (T1), 3 months post-intervention (T2) and 9 months post-intervention (T3). Each measurement point includes self-reported questionnaires and actigraphy (10 days). T0 and T1 measurements also include collection of blood and saliva samples. DISCUSSION:Light therapy has the potential to be an effective treatment for CRF in cancer survivors. This study will provide insights on its efficacy and potential mechanisms. If proven to be effective, light therapy will provide an easy to deliver, low-cost and low-burden intervention, introducing a new era in the treatment of CRF. TRIAL REGISTRATION:The study is registered at ClinicalTrials.gov on August 8th 2017( NCT03242902 ).

Dataset Information

Tailored exercise interventions to reduce fatigue in cancer survivors: study protocol of a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Tailored exercise interventions to reduce fatigue in cancer survivors: study protocol of a randomized controlled trial.

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