This phase I/II trial studies how well a mobile health application (app) intervention works in reducing the side effects of androgen deprivation therapy in patients with prostate cancer. The mobile health app may provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habits that may reduce the side effects associated with use of androgen deprivation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03761160.
PRIMARY OBJECTIVES:
I. To develop a mobile health app specifically designed for men newly initiated to androgen deprivation therapy (ADT). (Phase I)
II. To evaluate the usability and acceptability of the app in 10 participants (2 staff members and 8 patients with prostate cancer). (Phase I)
III. To perform a 2:1 randomization pilot trial of app + usual care versus (vs.) usual care alone. (Phase II)
OUTLINE:
PHASE I: Participants attend a feasibility session over 60 minutes.
PHASE II: Patients are randomized to 1 of 2 arms.
ARM I: Patients use mobile health app consisting of physical activities and dietary regimen and also receive usual care.
ARM II: Patients receive usual care.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorQuoc-Dien Trinh