Prostate CancerNCT03761160
Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy
A study testing Mobile Health App in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Mobile Health App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2019to 10 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Mobile Health App, Usual care
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health AppOther
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 careOther
Usual care per hospital guidelines
| Study group | Role | What they receive |
|---|---|---|
| Mobile Health App | Experimental | 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 Receives: Other: Mobile Health App |
| Usual Care | Active comparator | Usual care per hospital guideline Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulation of body fat mass
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Measured: 2 years
Secondary outcomes (6)
Whole-body lean mass
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Measured: 2 years
Regional lean mass
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Measured: 2 years
Percent fat
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Measured: 2 years
Estimated visceral adipose
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start16 Jul 2019
- Primary completion28 Jan 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Responsible party
- Principal investigator, Quoc-Dien Trinh, MD, Dana-Farber Cancer Institute
- Investigators
- QUOC-DIEN TRINH, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761160
- Sponsor's protocol ID
- 17-692
- Status last verified
- Jun 2023
- First submitted
- 3 Nov 2018
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03761160
- Acronym / sponsor ID
- 17-692
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Health App | Experimental | Other: Mobile Health AppThe 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 | Active comparator | Other: Usual careUsual care per hospital guideline |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health Appmobile 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 | Mobile Health App |
| Usual careUsual care per hospital guidelines | Other | Usual Care |
Primary outcome
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.
6 secondary outcomes
Whole-body lean mass
Time frame: 2 years
Regional lean mass
Time frame: 2 years
Percent fat
Time frame: 2 years
Estimated visceral adipose
Time frame: 2 years
Application's performance on iOS and Android platforms
Time frame: 2 years
Application's ability to effectively motivate and track outcomes for patients
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
QUOC-DIEN TRINH, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health App in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulation of body fat mass (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.