Clinical trial NCT05258526: Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)
Official title: Home Based Exercise for Patients With Breast or Prostate Cancer During Treatment: a Feasibility Trial (The BENEFIT-CA Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Keywords: Cancer
Feasibility trial
Physical activity
Home based exercise
Trial adherence
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This a feasibility trial to assess a home-based exercise intervention individuals with breast or prostate cancer during treatment.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Trial adherence
timeFrame: Up to12 weeks.
Secondary outcomes:
measure: Recruitment yields
timeFrame: Up to 8 weeks before allocation to the study intervention.
measure: Adverse events throughout the study
timeFrame: Up to 12 weeks.
Other outcomes:
measure: Fatigue levels at baseline and at the end of the study
timeFrame: Baseline; Week 12.
measure: Quality of life, based on the Functional Assessment of Cancer Therapy (FACT questionnaire)
timeFrame: Baseline; Week 12.
measure: Walking capacity
timeFrame: Baseline; Week 12.
measure: Handgrip strength
timeFrame: Baseline; Week 12.
measure: Abdominal circumference
timeFrame: Baseline; Week 12.
measure: Physical activity levels
timeFrame: Single assessment at baseline.
measure: Patient selected outcomes
timeFrame: Week 12.
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Daniel Umpierre de Moraes, PhD
role: PRINCIPAL_INVESTIGATOR
References: