Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy
- Conditions
- Prostate Cancer
- Interventions
- Other: Mobile Health AppOther: Usual care
- Registration Number
- NCT03761160
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mobile Health App Mobile Health App The developed mobile health app will include the following facets: * Physical activities * Dietary regimen. * The physical activities facet will encourage patients to engage in physical activities, with daily prompts, encouragement, and tips. * Users will be asked to record the type of physical activity they engaged in during the week, and for how long. * The dietary aspect will ask patients to log what they ate during the day and to rate how 'healthy' it is Usual Care Usual care Usual care per hospital guideline
- Primary Outcome Measures
Name Time Method Accumulation of body fat mass 2 years This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
- Secondary Outcome Measures
Name Time Method Percent fat 2 years This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Estimated visceral adipose 2 years This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Application's performance on iOS and Android platforms 2 years This outcome (for phase 1 of the trial) will be collected in 10 participants through verbal responses and/or computer either by the research coordinator or the participant. All data collected will be anonymously recorded.
Whole-body lean mass 2 years This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Regional lean mass 2 years This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Application's ability to effectively motivate and track outcomes for patients 2 years This outcome (for phase 1 of the trial) will be collected in 10 participants through verbal responses and/or computer either by the research coordinator or the participant. All data collected will be anonymously recorded.
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States