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Trial record 78 of 1542 for:    Androgens

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03761160
Recruitment Status : Not yet recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
Prostate Cancer Foundation
Information provided by (Responsible Party):
QUOC-DIEN TRINH, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Mobile Health App Other: Usual care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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
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

Active Comparator: Usual Care
Usual care per hospital guideline
Other: Usual care
Usual care per hospital guidelines




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Regional lean mass [ Time Frame: 2 years ]
    This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.

  3. Percent fat [ Time Frame: 2 years ]
    This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.

  4. Estimated visceral adipose [ Time Frame: 2 years ]
    This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761160


Contacts
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Contact: QUOC-DIEN TRINH, MD 617-525-7350 QTRINH@BWH.HARVARD.EDU

Locations
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United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: QUOC-DIEN TRINH, MD    617-525-7350    QTRINH@BWH.HARVARD.EDU   
Principal Investigator: QUOC-DIEN TRINH, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Prostate Cancer Foundation
Investigators
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Principal Investigator: QUOC-DIEN TRINH, MD Brigham and Women's Hospital

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Responsible Party: QUOC-DIEN TRINH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03761160     History of Changes
Other Study ID Numbers: 17-692
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (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
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].

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by QUOC-DIEN TRINH, Dana-Farber Cancer Institute:
Prostate Cancer
Additional relevant MeSH terms:
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Androgens
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs