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

Breast Cancer Clinical Trial

— BENEFIT-CA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05258526
• Other study ID #: 2021-0262
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2022
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Daniel Umpierre de Moraes, PhD
• Phone: 555133596332
• Email: danielumpierre[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fatigue levels at baseline and at the end of the study	Fatigue scores using specific questionnaires of Functional Assessment of Cancer Therapy (FACT questionnaire) for breast or prostate cancer patients.	Baseline; Week 12.
Other	Quality of life, based on the Functional Assessment of Cancer Therapy (FACT questionnaire)	Quality of life scores using specific questionnaires of FACT (Functional Assessment of Cancer Therapy) for breast or prostate cancer patients.	Baseline; Week 12.
Other	Walking capacity	Total distance (in meters) performed during the six minute walk test.	Baseline; Week 12.
Other	Handgrip strength	Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer.	Baseline; Week 12.
Other	Abdominal circumference	Anthropometric measure of the highest abdominal circumference, using a metallic measuring tape.	Baseline; Week 12.
Other	Physical activity levels	Physical activity calculated in minutes and intensity per week, of physical activity using the International Physical Activity Questionnaire (IPAQ).	Single assessment at baseline.
Other	Patient selected outcomes	Through the development of the study, participants will be asked to engage in a focal group to discuss outcomes relevant to be assessed in trials with exercise interventions targeted for patients with breast or prostate cancer.	Week 12.
Primary	Trial adherence	Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.	Up to12 weeks.
Secondary	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.
Secondary	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.