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

NCT ID: NCT05258526

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2023-12-30

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.

Conditions

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Breast Cancer Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This a feasibility trial to assess a home-based exercise intervention individuals with breast or prostate cancer during treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home-based exercise program

This is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment.

Group Type EXPERIMENTAL

Home based exercise training

Intervention Type OTHER

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.

Interventions

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Home based exercise training

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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Umpierre de Moraes, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Daniel Umpierre de Moraes, PhD

Role: CONTACT

555133596332

Larissa Xavier Neves da Silva, Master

Role: CONTACT

555133596332

Facility Contacts

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Daniel Umpierre de Moraes, PhD

Role: primary

555133596332

Larissa Xavier Neves da Silva, MSc

Role: backup

555133596332

References

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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.

Reference Type DERIVED
PMID: 37752564 (View on PubMed)

Other Identifiers

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2021-0262

Identifier Type: -

Identifier Source: org_study_id

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