Prostate Cancer
Conditions
Keywords
Prostate Cancer
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.
Interventions
OTHERMobile Health App
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
OTHERUsual care
Usual care per hospital guidelines
Sponsors
Prostate Cancer Foundation
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Regional lean mass | 2 years | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. |
| Percent fat | 2 years | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. |
| Whole-body lean mass | 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. |
| 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. |
| Estimated visceral adipose | 2 years | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. |
Countries
United States
Outcome results
None listed