Breast CancerBENEFIT-CANCT05258526
Home Based Exercise for Patients With Breast or Prostate Cancer (The BENEFIT-CA Study)
A study testing Home based exercise training in people with Breast Cancer and Prostate Cancer, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- What is being tested?
- Home based exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Apr 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007
Daniel Umpierre de Moraes, PhD, 555133596332, danielumpierre@hcpa.edu.br
Larissa Xavier Neves da Silva, MSc, 555133596332, larissaxns@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Prostate Cancer
- Being tested
- Home based exercise training
- Keywords
- Cancer, Feasibility trial, Physical activity, Home based exercise, Trial adherence
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based exercise program | Experimental | This is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment. Receives: Other: Home based exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial adherence
Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.
Measured: Up to12 weeks.
Secondary outcomes (2)
Recruitment yields
Proportion of included participants (who signed the informed consent) in relation to the total number of screened individuals for eligibility.
Measured: 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.
Measured: Up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start7 Apr 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Umpierre de Moraes, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258526
- Sponsor's protocol ID
- 2021-0262
- Acronym
- BENEFIT-CA
- Status last verified
- Aug 2022
- First submitted
- 7 Feb 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
da Silva LXN, Leite JS, Ignacio AC, Massierer FD, Pfeifer LO, Dos Santos Cardoso LA, Alano TS, Umpierre D. The "home-based exercise for breast and prostate cancer patients during treatment-a feasibility trial" (BENEFIT CA trial): rationale and methodological protocol. Pilot Feasibility Stud. 2023 Sep 26;9(1):165. doi: 10.1186/s40814-023-01393-0.
PubMed 37752564
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Based Exercise for Patients With Breast or Prostate Cancer During Treatment: a Feasibility Trial (The BENEFIT-CA Study)
- ClinicalTrials.gov ID
- NCT05258526
- Acronym / sponsor ID
- BENEFIT-CA / 2021-0262
- Conditions
- Breast Cancer, Prostate Cancer
- Keywords
- Cancer, Feasibility trial, Physical activity, Home based exercise, Trial adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This a feasibility trial to assess a home-based exercise intervention individuals with breast or prostate cancer during treatment.
| Arm | Type | Receives |
|---|---|---|
| Home-based exercise program | Experimental | Other: Home based exercise trainingThis is a single study arm consisting of a home-based exercise program for individuals with breast or prostate cancer during active treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home based exercise trainingThe 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. | Other | Home-based exercise program |
Primary outcome
Trial adherence
Time frame: Up to12 weeks.
Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study.
2 secondary outcomes
Recruitment yields
Time frame: Up to 8 weeks before allocation to the study intervention.
Adverse events throughout the study
Time frame: Up to 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Derived from this study: PubMed 37752564da Silva LXN, Leite JS, Ignacio AC, Massierer FD, Pfeifer LO, Dos Santos Cardoso LA, Alano TS, Umpierre D. The "home-based exercise for breast and prostate cancer patients during treatment-a feasibility trial" (BENEFIT CA trial): rationale and methodological protocol. Pilot Feasibility Stud. 2023 Sep 26;9(1):165. doi: 10.1186/s40814-023-01393-0.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Umpierre de Moraes, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based exercise training in people with Breast Cancer and Prostate Cancer, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Umpierre de Moraes, PhD (555133596332, danielumpierre@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial adherence (time frame: Up to12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05258526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.