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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Prostate Cancer
• Intervention / Treatment: Other: Home based exercise training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Umpierre de Moraes, PhD; Phone Number: 555133596332; Email: danielumpierre@hcpa.edu.br
• Study Contact Backup: Name: Larissa Xavier Neves da Silva, Master; Phone Number: 555133596332; Email: larissaxns@gmail.com

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-007
      • Recruiting
      • Hospital De Clinicas De Porto Alegre
      • Contact: Daniel Umpierre de Moraes, PhD; Phone Number: 555133596332; Email: danielumpierre@hcpa.edu.br
      • Contact: Larissa Xavier Neves da Silva, MSc; Phone Number: 555133596332; Email: larissaxns@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial adherence	Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.	Up to12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Walking capacity	Total distance (in meters) performed during the six minute walk test.	Baseline; Week 12.
Handgrip strength	Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer.	Baseline; Week 12.
Abdominal circumference	Anthropometric measure of the highest abdominal circumference, using a metallic measuring tape.	Baseline; Week 12.
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.
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.

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Daniel Umpierre de Moraes, PhD, Hospital De Clinicas De Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Physical activity; Feasibility trial; Home based exercise; Trial adherence
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2021-0262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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.

IPD Sharing 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.

• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No