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

Primary Purpose

Breast Cancer, Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Home based exercise training
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Cancer, Feasibility trial, Physical activity, Home based exercise, Trial adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home-based exercise program

Arm Description

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

Outcomes

Primary Outcome Measures

Trial adherence
Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.

Secondary Outcome Measures

Recruitment yields
Proportion of included participants (who signed the informed consent) in relation to the total number of screened individuals for eligibility.
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.

Full Information

First Posted
February 7, 2022
Last Updated
August 5, 2022
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT05258526
Brief Title
Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)
Acronym
BENEFIT-CA
Official Title
Home Based Exercise for Patients With Breast or Prostate Cancer During Treatment: a Feasibility Trial (The BENEFIT-CA Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer
Keywords
Cancer, Feasibility trial, Physical activity, Home based exercise, Trial adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This a feasibility trial to assess a home-based exercise intervention individuals with breast or prostate cancer during treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based exercise program
Arm Type
Experimental
Arm Description
This is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment.
Intervention Type
Other
Intervention Name(s)
Home based exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Trial adherence
Description
Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.
Time Frame
Up to12 weeks.
Secondary Outcome Measure Information:
Title
Recruitment yields
Description
Proportion of included participants (who signed the informed consent) in relation to the total number of screened individuals for eligibility.
Time Frame
Up to 8 weeks before allocation to the study intervention.
Title
Adverse events throughout the study
Description
Self-reported adverse events, related or not to the study. These measures will be mostly received by phone calls or text messaging.
Time Frame
Up to 12 weeks.
Other Pre-specified Outcome Measures:
Title
Fatigue levels at baseline and at the end of the study
Description
Fatigue scores using specific questionnaires of Functional Assessment of Cancer Therapy (FACT questionnaire) for breast or prostate cancer patients.
Time Frame
Baseline; Week 12.
Title
Quality of life, based on the Functional Assessment of Cancer Therapy (FACT questionnaire)
Description
Quality of life scores using specific questionnaires of FACT (Functional Assessment of Cancer Therapy) for breast or prostate cancer patients.
Time Frame
Baseline; Week 12.
Title
Walking capacity
Description
Total distance (in meters) performed during the six minute walk test.
Time Frame
Baseline; Week 12.
Title
Handgrip strength
Description
Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer.
Time Frame
Baseline; Week 12.
Title
Abdominal circumference
Description
Anthropometric measure of the highest abdominal circumference, using a metallic measuring tape.
Time Frame
Baseline; Week 12.
Title
Physical activity levels
Description
Physical activity calculated in minutes and intensity per week, of physical activity using the International Physical Activity Questionnaire (IPAQ).
Time Frame
Single assessment at baseline.
Title
Patient selected outcomes
Description
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.
Time Frame
Week 12.

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
The trial is designed for female breast cancer patients and male prostate cancer patients.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Umpierre de Moraes, PhD
Phone
555133596332
Email
danielumpierre@hcpa.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
Larissa Xavier Neves da Silva, Master
Phone
555133596332
Email
larissaxns@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Umpierre de Moraes, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-007
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Umpierre de Moraes, PhD
Phone
555133596332
Email
danielumpierre@hcpa.edu.br
First Name & Middle Initial & Last Name & Degree
Larissa Xavier Neves da Silva, MSc
Phone
555133596332
Email
larissaxns@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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: 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). 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. 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 URL
https://osf.io/gw2x6/

Learn more about this trial

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

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