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

• ClinicalTrials.gov Identifier: NCT03761160
• Recruitment Status: Completed
• First Posted: December 3, 2018
• Last Update Posted: June 22, 2023
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: Prostate Cancer Foundation
• Information provided by (Responsible Party): Quoc-Dien Trinh, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: November 3, 2018
• First Posted Date: December 3, 2018
• Last Update Posted Date: June 22, 2023
• Actual Study Start Date: July 16, 2019
• Actual Primary Completion Date: January 28, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 29, 2018)

Accumulation of body fat mass [ Time Frame: 2 years ]

This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 29, 2018)

• Whole-body lean mass [ Time Frame: 2 years ]
  This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
• Regional lean mass [ Time Frame: 2 years ]
  This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
• Percent fat [ Time Frame: 2 years ]
  This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
• Estimated visceral adipose [ Time Frame: 2 years ]
  This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
• Application's performance on iOS and Android platforms [ Time Frame: 2 years ]
  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.
• Application's ability to effectively motivate and track outcomes for patients [ Time Frame: 2 years ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Prostate Cancer

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
• Other: Usual care
  Usual care per hospital guidelines

Study Arms

• 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
  Intervention: Other: Mobile Health App
• Active Comparator: Usual Care
  Usual care per hospital guideline
  Intervention: Other: Usual care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 17, 2023): 10
• Original Estimated Enrollment (submitted: November 29, 2018): 60
• Actual Study Completion Date: July 10, 2020
• Actual Primary Completion Date: January 28, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 40 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03761160
• Other Study ID Numbers: 17-692
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (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].

• Current Responsible Party: Quoc-Dien Trinh, MD, Dana-Farber Cancer Institute
• Original Responsible Party: QUOC-DIEN TRINH, Dana-Farber Cancer Institute, Principal Investigator
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Prostate Cancer Foundation

Investigators

• Principal Investigator: QUOC-DIEN TRINH, MD; Brigham and Women's Hospital

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: June 2023