Clinical trial · Interventional
Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy
Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy: A Randomize Pilot Trial in Men Newly Treated With Androgen Deprivation Therapy
NCT03761160CI-TRIAL-00067458completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mobile Health App | Other | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mobile Health App
- description
- 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
- interventionNames
- Other: Mobile Health App
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- Usual care per hospital guideline
- interventionNames
- Other: Usual care
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.