Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)
BENEFIT-CA
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedStudy Start
First participant enrolled
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedAugust 9, 2022
August 1, 2022
1.7 years
February 7, 2022
August 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trial adherence
Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.
Up to12 weeks.
Secondary Outcomes (2)
Recruitment yields
Up to 8 weeks before allocation to the study intervention.
Adverse events throughout the study
Up to 12 weeks.
Other Outcomes (7)
Fatigue levels at baseline and at the end of the study
Baseline; Week 12.
Quality of life, based on the Functional Assessment of Cancer Therapy (FACT questionnaire)
Baseline; Week 12.
Walking capacity
Baseline; Week 12.
- +4 more other outcomes
Study Arms (1)
Home-based exercise program
EXPERIMENTALThis is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007, Brazil
Related Publications (1)
da Silva LXN, Leite JS, Ignacio AC, Massierer FD, Pfeifer LO, Dos Santos Cardoso LA, Alano TS, Umpierre D. The "home-based exercise for breast and prostate cancer patients during treatment-a feasibility trial" (BENEFIT CA trial): rationale and methodological protocol. Pilot Feasibility Stud. 2023 Sep 26;9(1):165. doi: 10.1186/s40814-023-01393-0.
PMID: 37752564DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Umpierre de Moraes, PhD
Hospital de Clínicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2022
First Posted
February 28, 2022
Study Start
April 7, 2022
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
August 9, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
- Time Frame
- Due to space and management constraints, we are planning: 1. To retain and store project documentation (informed consents, IRB communication, subjects' communication) for at least 10 years after the study completion (anticipated time: up to 2033). 2. To retain and share project resources (instruments, intervention materials) as long as public repositories (e.g., Zenodo, OSF, figshare) provide sharing services at no cost. 3. To retain and share datasets as long as public repositories (e.g., Zenodo, OSF, figshare) provide sharing services at no cost.
- Access Criteria
- All the files will be password-protected and only investigators or data managers designated to use the files will be given access. Different passwords will be used for different users, which allows auditing to be made more easily. Although we do not plan to request justification to release the datasets, we do plan to share the data in a controlled approach. Therefore, once the datasets are made available at the Zenodo.org platform, only registered users will be able to download files. This procedure allows us to keep a record of data requests.
Files will be as de-identified as possible before public data sharing. After data protection and data handling routines, de-identified data will be readily available to all project contributors. We consider research data gathered from data collection from research participants pertains primarily to these individuals. Therefore, all individual data will be available to their owners throughout the project. Structured data that will result from this research project will pertain to the PI (Daniel Umpierre), who will be responsible for data integrity, and to the institution (Hospital de Clinicas de Porto Alegre). The specific structure for data sharing as well as plataforms are still to be defined. As soon, we define the remaining details of our data sharing strategy the IPD plan will be updated.