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

NCT03761160 | Completed

• 1 other identifier: 17-692
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Whole-body lean mass

  2 years

• Regional lean mass

  2 years

• Percent fat

  2 years

• Estimated visceral adipose

  2 years

• Application's performance on iOS and Android platforms

  2 years

Study Arms (2)

Mobile Health App

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

Usual care per hospital guideline

Other: Usual care

Interventions

Mobile Health App OTHER

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

Mobile Health App

Usual care OTHER

Usual care per hospital guidelines

Usual Care

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Prostate Cancer Foundation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• QUOC-DIEN TRINH, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2018
• First Posted: December 3, 2018
• Study Start: July 16, 2019
• Primary Completion: January 28, 2020
• Study Completion: July 10, 2020
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Requests may be directed to: \[contact information for Sponsor- Investigator or designee\].

Locations

US (1)