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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home based exercise training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Trial adherence | Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study. | Up to12 weeks. |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
The trial is designed for female breast cancer patients and male prostate cancer patients.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Umpierre de Moraes, PhD | Contact | 555133596332 | danielumpierre@hcpa.edu.br | |
| Larissa Xavier Neves da Silva, Master | Contact | 555133596332 | larissaxns@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Umpierre de Moraes, PhD | Hospital de ClÃnicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-007 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37752564 | Derived | 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. |
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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.
Due to space and management constraints, we are planning:
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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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This a feasibility trial to assess a home-based exercise intervention individuals with breast or prostate cancer during treatment.
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|
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. |
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. |
| D005834 |
| Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |