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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761160
• Other study ID #: 17-692
• Status: Completed
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: July 10, 2020

Study information

• Verified date: June 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 10, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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
• Usual care
Usual care per hospital guidelines

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Prostate Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Whole-body lean mass	This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.	2 years
Secondary	Regional lean mass	This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.	2 years
Secondary	Percent fat	This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.	2 years
Secondary	Estimated visceral adipose	This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.	2 years
Secondary	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
Secondary	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