Dataset Information

The "home-based exercise for breast and prostate cancer patients during treatment-a feasibility trial" (BENEFIT CA trial): rationale and methodological protocol.

ABSTRACT:

Background

Physical activity has been shown to benefit patients undergoing adjuvant cancer therapy. Although exercise interventions may be applied in several settings, most trials have focused on specialized facilities for their interventions. While these approaches benefit the access for individuals living near exercise centers, it hampers the assessment of real-world effectiveness. Therefore, evaluating the feasibility and implementation of home-based models of exercise training, especially in low-to-middle-income settings, may inform future physical activity trials and programs. In this article, we present the protocol for the BENEFIT CA trial, which aims to assess the implementation of a remote exercise intervention for patients with breast cancer or prostate cancer, primarily quantifying adherence to an exercise program.

Methods

This is a 12-week study, utilizing a non-randomized, single-arm design to assess the feasibility of a home-based exercise training. The intervention is remotely guided, and participants also receive an educational component about cancer and exercise. The study aims to recruit 40 patients diagnosed with breast cancer and 40 patients diagnosed with prostate cancer, all of whom undergoing active hormonal treatment. The primary outcome is the level of adherence, indicated as the proportion of performed exercise episodes. Secondary outcomes include recruitment rates, fatigue, quality of life, and functional capacity. Adverse events will be monitored throughout the study. Because this is a feasibility trial, the statistical analysis plan is based on descriptive statistics, which encompasses an intention-to-treat analysis and a plan for handling missing data.

Discussion

This is a low-cost feasibility study to orient the design of a wide-range, pragmatic phase 3 trial based on remote exercise intervention. With this study, we aim to better understand the adherence and implementation strategies regarding home-based exercise for the proposed population and, in the near future, move forward to a randomized clinical trial. In addition, this trial may contribute to engage patients with cancer in exercise programs throughout their treatment and beyond.

Trial registration

This trial has been approved by the Hospital de Clínicas de Porto Alegre Ethics Committee/IRB (48,869,621.9.0000.5327), and it is registered at Clinicaltrials.gov (NCT05258526), registered on February 25, 2022, prior to the beginning of the study.

SUBMITTER: da Silva LXN

PROVIDER: S-EPMC10521479 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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The "home-based exercise for breast and prostate cancer patients during treatment-a feasibility trial" (BENEFIT CA trial): rationale and methodological protocol.

da Silva Larissa Xavier Neves LXN Leite Jayne Santos JS Ignacio Andresa Conrado AC Massierer Fernanda Dias FD Pfeifer Lucinéia Orsolin LO Dos Santos Cardoso Linda Ariene LA Alano Tainá Silveira TS Umpierre Daniel D

Pilot and feasibility studies 20230926 1

<h4>Background</h4>Physical activity has been shown to benefit patients undergoing adjuvant cancer therapy. Although exercise interventions may be applied in several settings, most trials have focused on specialized facilities for their interventions. While these approaches benefit the access for individuals living near exercise centers, it hampers the assessment of real-world effectiveness. Therefore, evaluating the feasibility and implementation of home-based models of exercise training, espec ...[more]

PMID: 37752564

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Project description:IntroductionLiver disease is the third most common cause of premature mortality in the UK. Liver failure accelerates frailty, resulting in skeletal muscle atrophy, functional decline and an associated risk of liver transplant waiting list mortality. However, there is limited research investigating the impact of exercise on patient outcomes pre and post liver transplantation. The waitlist period for patients listed for liver transplantation provides a unique opportunity to provide and assess interventions such as prehabilitation.Methods and analysisThis study is a phase I observational study evaluating the feasibility of conducting a randomised control trial (RCT) investigating the use of a home-based exercise programme (HBEP) in the management of patients awaiting liver transplantation. Twenty eligible patients will be randomly selected from the Queen Elizabeth University Hospital Birmingham liver transplant waiting list. Participants will be provided with an individually tailored 12-week HBEP, including step targets and resistance exercises. Activity trackers and patient diaries will be provided to support data collection. For the initial 6 weeks, telephone support will be given to discuss compliance with the study intervention, achievement of weekly targets, and to address any queries or concerns regarding the intervention. During weeks 6-12, participants will continue the intervention without telephone support to evaluate longer term adherence to the study intervention. On completing the intervention, all participants will be invited to engage in a focus group to discuss their experiences and the feasibility of an RCT.Ethics and disseminationThe protocol is approved by the National Research Ethics Service Committee North West - Greater Manchester East and Health Research Authority (REC reference: 17/NW/0120). Recruitment into the study started in April 2017 and ended in July 2017. Follow-up of participants is ongoing and due to finish by the end of 2017. The findings of this study will be disseminated through peer-reviewed publications and international presentations. In addition, the protocol will be placed on the British Liver Trust website for public access.Trial registration numberNCT02949505; Pre-results.

Project description:BackgroundMen with metastatic castrate-resistant prostate cancer can experience an array of treatment-related side effects. Accumulating evidence suggests exercise may alleviate some of these adversities and assist in disease management. However, empirical evidence in advanced prostate cancer patients remains limited. The purpose of this study is to determine whether men with metastatic prostate cancer, who are ineligible for high-intensity exercise, can partake in a home-based, moderate-intensity exercise program and the impact of doing so on quality of life and physical fitness parameters.MethodsThirty men with adenocarcinoma of the prostate and progressive systemic, metastatic disease will be recruited. Clinicians will screen patients against inclusion criteria to determine eligibility. All men enrolled will be prescribed a tailored, home-based, moderate-intensity exercise intervention consisting of aerobic and strengthening components for 12 weeks. Patients will receive supplementary education materials and weekly behavioural change consultations throughout the intervention. The primary outcome will be the feasibility of delivering such an intervention in men with metastatic disease. Secondary endpoints including skeletal events will be monitored for safety, as will the feasibility of patient-reported outcome measures and the sampling time points, generating data pertaining to completion rates and potential effect in future trials. General physical fitness will be assessed during these visits, using timed sit-to-stand testing and a 6-min walking test. Prior to each visit, objective physical activity levels will be captured for 7 days using an accelerometer, to determine the feasibility of this technology and the quality of data obtained. In parallel with the feasibility aspects of the trial, changes compared to baseline will be reported. Direct regular contact will also serve as a feedback loop, should any issues arise. This study has received ethical approval from the Office for Research Ethics Committees Northern Ireland.ConclusionsThis study aims to determine the potential utility of a home-based exercise intervention in managing side effects associated with advanced prostate cancer and its treatment. This feasibility trial will inform the design and implementation of a larger randomised control trial to determine the efficacy of moderate aerobic and strengthening exercise as an adjuvant therapy in men with metastatic prostate cancer. Collecting such evidence provides further support for exercise in this paradigm and potential for its inclusion as a low-toxicity therapy in standard cancer care, in the longer term.Trial registrationClinicalTrials.gov, NCT03658486Trial sponsor: Queen's University Belfast (Reference: B18/15). Contact: Dr. Paula Tighe, Research and Enterprise, Queen's University Belfast. Telephone: 02890 973,296. Email: p.tighe@qub.ac.uk. The sponsor reviewed the protocol and ethical application prior to submission.Protocol issue: Version 1 (18th May 2018). Authors: MB, MM, SJ and GP.

Project description:IntroductionEffective interventions to promote upper-limb recovery poststroke are characterised by intensive and repetitive movements. However, the repetitive nature of practice may adversely impact on adherence. Therefore, the development of rehabilitation devices that can be used safely and easily at home, and are motivating, enjoyable and affordable is essential to the health and well-being of stroke survivors.The Neurofenix platform is a non-immersive virtual reality device for poststroke upper-limb rehabilitation. The platform uses a hand controller (a NeuroBall) or arm bands (NeuroBands) that facilitate upper-limb exercise via games displayed on a tablet. The Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke trial aims to determine the safety, feasibility and acceptability of the Neurofenix platform for home-based rehabilitation of the upper-limb poststroke.Methods and analysisThirty people poststroke will be provided with a Neurofenix platform, consisting of a NeuroBall or NeuroBands (dependent on impairment level), seven specially designed games, a tablet and handbook to independently exercise their upper limb for 7 weeks. Training commences with a home visit from a research therapist to teach the participant how to safely use the device. Outcomes assessed at baseline and 8 weeks and 12 weeks are gross level of disability, pain, objectively measured arm function and impairment, self-reported arm function, passive range of movement, spasticity, fatigue, participation, quality of life (QOL) and health service use. A parallel process evaluation will assess feasibility, acceptability and safety of the intervention through assessment of fidelity to the intervention measured objectively through the Neurofenix platform, a postintervention questionnaire and semistructured interviews exploring participants' experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on QOL and resource use.Ethics and disseminationEthics approval granted from Brunel University London (10249-MHR-Mar/2018-12322-2). Trial results will be submitted for publication in journals, presented at national and international conferences and distributed to people with stroke.Trial registration numberISRCTN60291412; Pre-results.

Project description:BackgroundCurrent guidelines emphasize cancer patients should increase their physical activity levels, encouraging physical exercise practice as a complementary therapy to mitigate adverse effects during treatment. Telehealth can be a feasible method to improve adherence and interventional support for breast cancer patients, of which most do not meet sufficient physical activity levels after diagnosis. The Adaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth) study aims to investigate the effects of a 12-week telehealth multicomponent training program plus a health education program (MTHE), compared to a health education program alone (HE), on physical and psychological outcomes in breast cancer patients undergoing treatment.MethodsThis study is a randomized controlled trial. Women undergoing primary treatment (during or after chemotherapy) for breast cancer (stages I-III) will be randomly assigned to MTHE (twice a week) or HE (once a week). MTHE components are mobility, aerobic, balance, resistance, and flexibility home-based exercises, supervised by video call. The primary study outcome is cancer-related fatigue. The secondary outcomes are quality of life, symptoms of depression and anxiety, physical activity level, cancer-related cognitive impairment, and functional capacity. Other outcomes are adherence to interventions and a follow-up questionnaire evaluating the individual perception in motivation, lifestyle changes, and main barriers to participation. All outcomes will be remotely assessed before and after intervention. Our analysis will follow the intention-to-treat approach and per-protocol criteria, with additional sub-group analysis.DiscussionTo our knowledge, this is the first randomized clinical trial in breast cancer patients using a face-to-face videoconference strategy to supervise physical exercise. Our hypothesis is of superiority for the effects of MTHE on primary and secondary outcomes compared to the effects of only the health education intervention.Trial registrationAdaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth), NCT04641377. Registered on 23 November 2021, https://clinicaltrials.gov/ct2/show/NCT04641377.

Project description:IntroductionNovel therapies for pulmonary hypertension (PH) have improved survival and slowed disease progression. However, patients still present with symptoms of exertional dyspnoea and fatigue, which impacts their ability to perform activities of daily living, reduces exercise tolerance and impairs their quality of life (QoL). Exercise training has shown to be safe and effective at enhancing QoL and physical function in PH patients, yet it remains an underused adjunct therapy. Most exercise training for PH patients has been offered through hospital-based programmes. Home-based exercise programmes provide an alternative model that has the potential to increase the availability and accessibility of exercise training as an adjunct therapy in PH. The purpose of this study is to investigate the feasibility, acceptability, utility and safety of a novel remotely supervised home-based PH exercise programme.MethodsSingle arm intervention with a pre/post comparisons design and a follow-up maintenance phase will be employed. Eligible participants (n=25) will be recruited from the Mater Misericordiae University Hospital PH Unit. Participants will undergo a 10-week home-based exercise programme, with induction training, support materials, telecommunication support and health coaching sessions followed by a 10-week maintenance phase. The primary outcomes are feasibility, acceptability, utility and safety of the intervention. Secondary outcomes will include the impact of the intervention on exercise capacity, physical activity, strength, health-related QoL and exercise self-efficacy.Ethics and disseminationEthics approval has been obtained from the Mater Misericordiae Institutional Review Board REF:1/378/2032 and Dublin City University Research Ethics DCUREC/2018/246. A manuscript of the results will be submitted to a peer-reviewed journal and results will be presented at conferences, community and consumer forums and hospital research conferences.Trial registration numberISRCTN83783446; Pre-results.

Project description:BackgroundChronic obstructive pulmonary disease (COPD) is a progressive condition associated with physical and cognitive impairments contributing to difficulty in performing activities of daily living (ADLs) that require dual tasking (eg, walking and talking). Despite evidence showing that cognitive decline occurs among patients with COPD and may contribute to functional limitations and decreased health-related quality of life (HRQL), pulmonary rehabilitation continues to focus mainly on physical training (ie, aerobic and strength exercises). An integrated cognitive and physical training program compared to physical training alone may be more effective in increasing dual-tasking ability among people living with COPD, leading to greater improvements in performance of ADLs and HRQL.ObjectiveThe aims of this study are to evaluate the feasibility of an 8-week randomized controlled trial of home-based, cognitive-physical training versus physical training for patients with moderate to severe COPD and derive preliminary estimates of cognitive-physical training intervention efficacy on measures of physical and cognitive function, dual task performance, ADLs, and HRQL.MethodsA total of 24 participants with moderate to severe COPD will be recruited and randomized into cognitive-physical training or physical training. All participants will be prescribed an individualized home physical exercise program comprising 5 days of moderate-intensity aerobic exercise (30-50 minutes/session) and 2 days of whole-body strength training per week. The cognitive-physical training group will also perform cognitive training for approximately 60 minutes, 5 days per week via the BrainHQ platform (Posit Science Corporation). Participants will meet once weekly with an exercise professional (via videoconference) who will provide support by reviewing the progression of their training and addressing any queries. Feasibility will be assessed through the recruitment rate, program adherence, satisfaction, attrition, and safety. The intervention efficacy regarding dual task performance, physical function, ADLs, and HRQL will be evaluated at baseline and at 4 and 8 weeks. Descriptive statistics will be used to summarize intervention feasibility. Paired 2-tailed t tests and 2-tailed t tests will be used to compare the changes in the outcome measures over the 8-week study period within and between the 2 randomized groups, respectively.ResultsEnrollment started in January 2022. It is estimated that the enrollment period will be 24 months long, with data collection to be completed by December 2023.ConclusionsA supervised home-based cognitive-physical training program may be an accessible intervention to improve dual-tasking ability in people living with COPD. Evaluating the feasibility and effect estimates is a critical first step to inform future clinical trials evaluating this approach and its effects on physical and cognitive function, ADL performance, and HRQL.Trial registrationClinicalTrials.gov NCT05140226; https://clinicaltrials.gov/ct2/show/NCT05140226.International registered report identifier (irrid)DERR1-10.2196/48666.

Project description:BackgroundClinical guidelines recommend prehabilitation with exercise training to optimize recovery after lung cancer surgery. However, the lack of access to facility-based exercise programs is a major barrier to routine participation. This study aimed to assess the feasibility of a home-based exercise intervention before lung cancer resection.MethodsWe conducted a prospective, two-site feasibility study, including patients scheduled for lung cancer surgery. Exercise prescription involved aerobic and resistance training with telephone-based supervision. The primary endpoint was overall feasibility (recruitment rate, retention rate, intervention adherence and acceptability). Secondary endpoints included safety and effects on health-related quality of life (HRQOL) and physical performance, evaluated at baseline, after the exercise intervention and 4-5 weeks after surgery.ResultsOver three months, 15 patients were eligible, and all agreed to participate (recruitment rate: 100%). A total of 14 patients completed the exercise intervention, and 12 patients were evaluated postoperatively (retention rate: 80%). The median length of the exercise intervention was 3 weeks. Patients performed an aerobic and resistance training volume higher than prescribed (median adherence rates of 104% and 111%, respectively). A total of nine adverse events occurred during the intervention (Grade 1, n = 8; Grade 2, n = 1), the most common being shoulder pain. After the exercise intervention, significant improvements were observed in the HRQOL summary score (mean difference, 2.9; 95% confidence interval [CI], from 0.9 to 4.8; p = 0.049) and the five-times sit-to-stand test score (median difference, -1.5; 95% CI, from -2.1 to -0.9; p = 0.001). After surgery, no significant effects on HRQOL and physical performance were observed.ConclusionA short-term preoperative home-based exercise intervention is feasible before lung cancer resection and may enhance accessibility to prehabilitation. Clinical effectiveness should be investigated in future studies.

Project description:BackgroundOur goal is to conduct a multicenter randomized controlled trial (RCT) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged ≥65 years with a vertebral fracture.ObjectivesThis pilot study will determine the feasibility of recruitment, retention, and adherence for the proposed trial.DesignThe proposed RCT will be a pilot feasibility study with 1:1 randomization to exercise or attentional control groups.SettingFive Canadian sites (1 community hospital partnered with an academic center and 4 academic hospitals or centers affiliated with an academic center) and 2 Australian centers (1 academic hospital and 1 center for community primary care, geriatric, and rehabilitation services).ParticipantsOne hundred sixty women aged ≥65 years with vertebral fracture at 5 Canadian and 2 Australian centers will be recruited.InterventionThe Build Better Bones With Exercise (B3E) intervention includes exercise and behavioral counseling, delivered by a physical therapist in 6 home visits over 8 months, and monthly calls; participants are to exercise ≥3 times weekly. Controls will receive equal attention.MeasurementsPrimary outcomes will include recruitment, retention, and adherence. Adherence to exercise will be assessed via calendar diary. Secondary outcomes will include physical function (lower extremity strength, mobility, and balance), posture, and falls. Additional secondary outcomes will include quality of life, pain, fall self-efficacy, behavior change variables, intervention cost, fractures, and adverse events. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to a priori criteria. Differences in secondary outcomes will be evaluated in intention-to-treat analyses via independent Student t tests, chi-square tests, or logistic regression. The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall alpha level is .05.LimitationsNo assessment of bone mineral density will be conducted. The proposed definitive trial will require a large sample size.ConclusionsThe viability of a large-scale exercise trial in women with vertebral fractures will be evaluated, as well as the effects of a home exercise program on important secondary outcomes.

Dataset Information

The "home-based exercise for breast and prostate cancer patients during treatment-a feasibility trial" (BENEFIT CA trial): rationale and methodological protocol.

Background

Methods

Discussion

Trial registration

Publications

The "home-based exercise for breast and prostate cancer patients during treatment-a feasibility trial" (BENEFIT CA trial): rationale and methodological protocol.

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