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

NCT ID: NCT03761160

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-16
• Study Completion Date: 2020-07-10

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Mobile Health App

Intervention Type: 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

Usual Care

Usual care per hospital guideline

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Usual care per hospital guidelines

Interventions

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

Intervention Type: OTHER

Usual care

Usual care per hospital guidelines

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Prostate Cancer Foundation

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Quoc-Dien Trinh, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

QUOC-DIEN TRINH, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

17-692

Identifier Type: -

Identifier Source: org_study_id