Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy: A Randomize Pilot Trial in Men Newly Treated With Androgen Deprivation Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Accumulation of body fat mass
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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. The first phase of the research study seeks to evaluate the experience of the first version of the mobile health app within a group of participants and what they think of it. The investigators are interested in how individuals react to the use of a developed mobile health app and what they think of it.
Investigators
Quoc-Dien Trinh, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •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.
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
Outcomes
Primary Outcomes
Accumulation of body fat mass
Time Frame: 2 years
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Secondary Outcomes
- Percent fat(2 years)
- Estimated visceral adipose(2 years)
- Application's performance on iOS and Android platforms(2 years)
- Whole-body lean mass(2 years)
- Regional lean mass(2 years)
- Application's ability to effectively motivate and track outcomes for patients(2 years)