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MOBILE HEALTH APP TO MITIGATE THE METABOLIC EFFECTS OF ANDROGEN DEPRIVATION THERAPY: A RANDOMIZED PILOT TRIAL IN MEN NEWLY TREATED WITH ANDROGEN DEPRIVATION THERAPY

Not Enrolling

Trial ID:NCT03761160

View complete trial on ClinicalTrials.gov

Protocol #:17-692

877-DF-TRIAL (877-338-7425)

Condition(s):Prostate Cancer

Phase:Not Applicable

Principal Investigator:Trinh, Quoc-Dien

Trial Description:
This research study seeks to develop and evaluate a mobile health app which aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habits.

Eligibility Requirements:
Phase 1
- All recruited participants must have owned a smartphone for >1 year
- English-speaking.
- Patients with prostate cancer aged between 40-75 years will be considered.
- No specific timeframe after prostate cancer diagnosis will be required for these patients.
- No limitations regarding their disease characteristics will be imposed (e.g. metastatic disease).
- Patients may or may not be currently receiving treatment Staff members will be recruited from
- Dana-Farber Cancer Institute Department of Medical Oncology,
- Brigham and Women's Hospital, Department of Surgery. Staff members aged between 40-75 years old will be considered. Phase 2
- Men diagnosed with prostate cancer presenting to DF/BWHCC
- About to initiate ADT for the first time will be considered.
- Age range 40-75-years
- The ability to walk 400 m
- Medical clearance from their primary physician
- English speaking
- Cognitively alert
- Literate
- Ability to read or hear with or without contacts/glass and hearing aid
- Ownership of a smartphone for >1yr
Exclusion Criteria:
- Men who have been under a rigorous structured exercise regime, such as individuals who engage in more than 900 minutes of moderate physical activity per week in the last 6 months will not be considered
- Post-ADT treatment
- Planned systemic chemotherapy
- Planned treatment with abiraterone or enzalutamide
- Bone metastases
- Acute illness
- Any musculoskeletal, cardiovascular, or neurologic disorders that could inhibit or put them at risk from exercising
- Subordinates to the PI

Protocol #: 17-692

Questions & Enrollment
877-DF-TRIAL
(877-338-7425)