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| Name | Class |
|---|---|
| Prostate Cancer Foundation | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Health App | Experimental | The developed mobile health app will include the following facets:
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| Usual Care | Active Comparator | Usual care per hospital guideline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Health App | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Accumulation of body fat mass | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Whole-body lean mass | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. | 2 years |
| Regional lean mass | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. |
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Inclusion Criteria:
Phase 1
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| QUOC-DIEN TRINH, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02215 | United States |
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
Data can be shared no earlier than 1 year following the date of publication.
Requests may be directed to: [contact information for Sponsor- Investigator or designee].
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Usual care | Other | Usual care per hospital guidelines |
|
| 2 years |
| Percent fat | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. | 2 years |
| Estimated visceral adipose | This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan. | 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. | 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. | 2 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |