Home-based exercise program for men with prostate cancer on hormone therapy
Behavioral Exercise TRaining for Medically Underserved Men Undergoing Androgen Deprivation Therapy for Prostate Cancer (BETR-PC)
This study is testing a home-based exercise program to see if it helps men with prostate cancer on hormone therapy stay active and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 41 Years to 85 Years |
| Sex | Male |
| Sponsor | Virginia Commonwealth University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06250751 on ClinicalTrials.gov |
What this trial studies
This study aims to refine a remote behavioral exercise training intervention specifically designed for medically underserved men undergoing Androgen Deprivation Therapy (ADT) for prostate cancer. The focus is on assessing the feasibility of recruiting participants and the acceptability of a home-based exercise program. The intervention will be delivered remotely, allowing participants to engage in exercise from their homes while receiving support and guidance. The study seeks to gather data that will inform a larger randomized trial in the future.
Who should consider this trial
Good fit: Ideal candidates include men, transwomen, or non-binary individuals diagnosed with stage II/III/IV prostate cancer currently receiving ADT and who meet specific age and health criteria.
Not a fit: Patients who are not undergoing ADT or who have serious medical conditions that prevent safe participation in an exercise program may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve the physical health and quality of life for prostate cancer patients undergoing hormone therapy.
How similar studies have performed: Other studies have shown promise in using home-based exercise interventions for cancer patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: To be eligible men, transwomen or non-binary individuals must meet the following criteria: * Be diagnosed with stage II/III/IV prostate cancer * Be currently undergoing treatment with ADT (intermittent or prolonged) * Have completed local curative-intent treatment, including prostatectomy or definitive radiation * Be \>40 years of age if non-Hispanic Black or rural dwelling; Otherwise \>60 years of age up to 85 * Be willing to give an informed consent and sign a HIPAA authorization form * Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation * Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview * Be without any serious medical condition that precludes safe participation in an exercise program * Speak English. * Meet protocol definition of medically underserved: which is consider medically underserved patients to be a) older men (\>75 years), b) men who live in rural zip code areas, or c) men who identify as being non-Hispanic Black. They may also be at the intersectionality of these groups (i.e., older Black men living in a rural zip code area).
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Alexander Lucas, PhD — Virginia Commonwealth University
- Study coordinator: Massey CTO CPC Team
- Email: MasseyCPC@vcu.edu
- Phone: 804-628-6430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.