Clinical trial NCT03761160: Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy
Official title: Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy: A Randomize Pilot Trial in Men Newly Treated With Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Foundation
First posted: 2018-12-03
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accumulation of body fat mass
timeFrame: 2 years
Secondary outcomes:
measure: Whole-body lean mass
timeFrame: 2 years
measure: Regional lean mass
timeFrame: 2 years
measure: Percent fat
timeFrame: 2 years
measure: Estimated visceral adipose
timeFrame: 2 years
measure: Application's performance on iOS and Android platforms
timeFrame: 2 years
measure: Application's ability to effectively motivate and track outcomes for patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: QUOC-DIEN TRINH, MD
role: PRINCIPAL_INVESTIGATOR
References: