Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy
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ClinicalTrials.gov Identifier: NCT03761160 |
Recruitment Status :
Completed
First Posted : December 3, 2018
Last Update Posted : June 22, 2023
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Other: Mobile Health App Other: Usual care | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 10 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 |
Actual Study Start Date : | July 16, 2019 |
Actual Primary Completion Date : | January 28, 2020 |
Actual Study Completion Date : | July 10, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Mobile Health App
The developed mobile health app will include the following facets:
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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
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Other: Usual care
Usual care per hospital guidelines |
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
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
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | QUOC-DIEN TRINH, MD | Brigham and Women's Hospital |
Responsible Party: | Quoc-Dien Trinh, MD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT03761160 |
Other Study ID Numbers: |
17-692 |
First Posted: | December 3, 2018 Key Record Dates |
Last Update Posted: | June 22, 2023 |
Last Verified: | June 2023 |
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]. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Prostate Cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |