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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health App
Usual care
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate Cancer

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Health App

Usual Care

Arm Description

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

Usual care per hospital guideline

Outcomes

Primary Outcome Measures

Accumulation of body fat mass
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.

Secondary Outcome Measures

Whole-body lean mass
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Regional lean mass
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Percent fat
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Estimated visceral adipose
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
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
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.

Full Information

First Posted
November 3, 2018
Last Updated
June 17, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Prostate Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03761160
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
January 28, 2020 (Actual)
Study Completion Date
July 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Prostate Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Health App
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care per hospital guideline
Intervention Type
Other
Intervention Name(s)
Mobile Health App
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
Usual care per hospital guidelines
Primary Outcome Measure Information:
Title
Accumulation of body fat mass
Description
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Whole-body lean mass
Description
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Time Frame
2 years
Title
Regional lean mass
Description
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Time Frame
2 years
Title
Percent fat
Description
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Time Frame
2 years
Title
Estimated visceral adipose
Description
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Time Frame
2 years
Title
Application's performance on iOS and Android platforms
Description
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.
Time Frame
2 years
Title
Application's ability to effectively motivate and track outcomes for patients
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
QUOC-DIEN TRINH, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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].

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

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