An interventional study of PROWESS in Prostate Cancer and Prostatic Neoplasms, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 14 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will complete study procedures as outlined: * Wear FitBit watch during the 12-week study period. * Group intervention sessions, in-person or virtually. * One optional follow-up session. * One-on-one, semi-structured interview with trained study staff to assess participant experience with intervention.
Behavioral: PROWESS
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.
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."
Time frame: At week 8-12 (intervention completion)
Change in Objective Physical Activity
Collected physical activity via FitBit measure of steps and activity classification.
Time frame: At Baseline and from weeks 1 - 12
Change in Self-Reported Exercise
Assessed by the Short-Form International Physical Activity Questionnaire (IPAQ), a self-reported measure of physical activity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Baseline and weeks 8-12
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital