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The goal of this research study is to conduct an open pilot of a behavioral change intervention called PROstate Cancer Wearables, Exercise, and Structured Supports (PROWESS) for integrating health behavior change tools and to increase exercise, reduce side effects of androgen deprivation therapy (ADT), and improve quality of life in Black and Hispanic/Latino men with prostate cancer.
The name of the intervention used in this research study is:
PROWESS (behavioral change intervention)
This research study is to test a behavioral change intervention called PROstate Cancer Wearables, Exercise, and Structured Supports (PROWESS) for integrating health behavior change tools with wearable technology, to increase exercise, reduce side effects of androgen deprivation therapy (ADT), and improve quality of life in Black and Hispanic/Latino men with prostate cancer on androgen deprivation therapy (ADT).
Study procedures include screening for eligibility, intervention sessions, questionnaires and surveys, and an exit interview with study staff.
Participation in this research study is expected to last for up to four months.
The goal and primary outcome of this open pilot study is refinement of the intervention and study procedures to allow for us to conduct a larger feasibility study in the future.
It is expected that about 10 people will take part in this research study.
This research study is being supported by the MGH Cancer Center
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROWESS | Experimental | Participants will complete study procedures as outlined:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROWESS | Behavioral | Structured, culturally sensitive behavior change intervention comprised of six video-based or in-person sessions with psychologist or social worker. FitBit is provided by study. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction | Assessed by the Client Satisfaction Questionnaire-3 (CSQ), a 3-item survey with answers ranging from 1-4, "quite dissatisfied" to "very satisfied." | At week 8-12 (intervention completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Objective Physical Activity | Collected physical activity via FitBit measure of steps and activity classification. | At Baseline and from weeks 1 - 12 |
| Change in Self-Reported Exercise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Lage, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | 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
Contact the Partners Innovations team at http://www.partners.org/innovation
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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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| ID | Term |
|---|---|
| D015016 | Yohimbine |
| ID | Term |
|---|---|
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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Assessed by the Short-Form International Physical Activity Questionnaire (IPAQ), a self-reported measure of physical activity.
| At Baseline and weeks 8-12 |
| Change in Participant Quality of Life | Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), which consists of five subscales assessing physical, functional, emotional, social wellbeing. | At Baseline and weeks 8-12 |
| Change in Psychological Distress Symptoms | Assessed by the Patient Health Questinnaire-4, a 4-item measure with two separate subscales to evaluate symptoms of anxiety and depression. | At Baseline and weeks 8-12 |
| Change in Self-Efficacy for Managing Symptoms | Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Symptoms Scale, an 8-item measure to evaluate self-efficacy. | At Baseline and weeks 8-12 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |