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
Protocol # :
17-692
Conditions
Prostate Cancer
Phase
Not Applicable
Disease Sites
Prostate
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

Inclusion Criteria:

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

17-692