Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy: A Randomize Pilot Trial in Men Newly Treated With Androgen Deprivation Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Mobile Health App
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Health App<br>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 | Other: Mobile Health App<br>* mobile health app aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habit<br>|
| Active Comparator: Usual Care<br>Usual care per hospital guideline | Other: Usual care<br>* Usual care per hospital guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulation of body fat mass | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole-body lean mass | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. | 2 years | 
| Regional lean mass | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. | 2 years | 
| Percent fat | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. | 2 years | 
| Estimated visceral adipose | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. | 2 years | 
| Application's performance on iOS and Android platforms | 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. | 2 years | 
| Application's ability to effectively motivate and track outcomes for patients | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer