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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Mobile Health App; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Mobile 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
Active Comparator: Usual Care; Usual care per hospital guideline	Other: Usual care; Usual care per hospital guidelines

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Prostate Cancer Foundation
• Investigators: Principal Investigator: QUOC-DIEN TRINH, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Actual): January 28, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 17-692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• IPD Sharing Access Criteria: Requests may be directed to: [contact information for Sponsor- Investigator or designee].
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No