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

H

Hospital de Clinicas de Porto Alegre

Status

Enrolling

Conditions

Breast Cancer
Prostate Cancer

Treatments

Other: Home based exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT05258526
2021-0262

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Home-based exercise program
Experimental group
Description:
This is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment.
Treatment:
Other: Home based exercise training

Trial contacts and locations

1

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Central trial contact

Daniel Umpierre de Moraes, PhD; Larissa Xavier Neves da Silva, Master

Data sourced from clinicaltrials.gov

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