Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)

Study Overview
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Brief Summary
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The purpose of this trial is to evaluate the feasibility of a home based exercise program for individuals with breast or prostate cancer patients undergoing active treatment.

Detailed Description
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This feasibility trial aims to assess a home-based exercise program, including a 3-month intervention of structured physical activity and health education for individuals with breast or prostate cancer. The main objective of this trial is to assess the adherence of cancer patients to a program of structured exercise, mixed with a health education approach, implemented and accompanied in a remote approach. The data collection will include variables related to: (a) recruitment and retentions rates; (b) attendance to exercise sessions; (c) fatigue and quality of life levels; (d) functional capacity levels; (e) adverse events related or not to the study; (f) patient selected outcomes.

Official Title
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Home Based Exercise for Patients With Breast or Prostate Cancer During Treatment: a Feasibility Trial (The BENEFIT-CA Study)

Conditions
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Breast Cancer, Prostate Cancer

Intervention / Treatment
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* Other: Home based exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: eighteen years old minimum; be living in Porto Alegre or metropolitan region; breast cancer stage 0 - III OR localized prostate cancer; undergoing hormonal treatment / manipulation in isolation or combined with other therapies three months prior to the entrance in the study; hormonal therapy / manipulation planned to be active throughout the study duration; not engaged in any exercise training for more than once a week for the past 6 months; in case of previous surgical procedure, the patient must have medical clearance at the moment of the contact to begin the study or be cleared to do so in the near future (up to two weeks). Exclusion Criteria: metastatic phase / progression of the disease or active regional location prior to beginning of the study; inability to understand the terms and conditions of study due to language, hearing, cognitive or severe psychiatric issues; another family member, who lives at the same residence, participating in the study; planning to move or major absence (more than two weeks) during the study; history of cardiovascular disease (except controlled hypertension) or severe cardiopulmonary disease, as well as history of heart attack, revascularization procedures, profound venous thrombosis, encephalic vascular accident (brain stroke) or pulmonary embolism in the past twelve months; chronic pulmonary disease that requires oxygen or corticosteroid therapy; kidney disease with or that is going to begin the use of dialysis or waiting for a kidney transplant; severe nausea, anorexia or any other condition which does not allow to perform physical exercise; medical contraindication to exercise training.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This a feasibility trial to assess a home-based exercise intervention individuals with breast or prostate cancer during treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based exercise program<br>This is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment. | Other: Home based exercise training<br>* The intervention will be based on a remote approach, lasting 12 weeks. The training routine will consist of aerobic (walking), muscle strengthening and stretching exercises, with a frequency of three days per week. The contents related to the exercise prescription will be made available by phone call, text messages and short videos for exercise demonstration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trial adherence | Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study. | Up to12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment yields | Proportion of included participants (who signed the informed consent) in relation to the total number of screened individuals for eligibility. | Up to 8 weeks before allocation to the study intervention. | 
| Adverse events throughout the study | Self-reported adverse events, related or not to the study. These measures will be mostly received by phone calls or text messaging. | Up to 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feasibility trial, Cancer, Physical activity, Home based exercise, Trial adherence