PROWESS (PROstate Cancer Wearables Exercise and Structured Supports): A Pilot Supportive Care Intervention

NCT05755490 | Completed

• 1 other identifier: 22-609
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Prostate Cancer; Prostatic Neoplasms

Keywords

Prostate Cancer; Prostatic Neoplasms; Androgen Deprivation Therapy; ADT; CBR; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Change in Objective Physical Activity

  At Baseline and from weeks 1 - 12

• Change in Self-Reported Exercise

  At Baseline and weeks 8-12

• Change in Participant Quality of Life

  At Baseline and weeks 8-12

• Change in Psychological Distress Symptoms

  At Baseline and weeks 8-12

• Change in Self-Efficacy for Managing Symptoms

  At Baseline and weeks 8-12

Study Arms (1)

PROWESS

EXPERIMENTAL

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

Interventions

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.

PROWESS

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with prostate cancer.
• Planning to be on androgen deprivation therapy (ADT) for at least three months
• Black Race AND/OR Hispanic/Latino Ethnicity (confirmed by patient self-report)
• Verbal fluency in English or Spanish.
• Receiving ongoing oncology care at MGH Cancer Center.
• Age ≥ 18 years.
• Self-Report less than or equal to 150 minutes of moderate or vigorous structured exercise per week, as assessed by the Exercise is Medicine Physical Activity Vital Sign Assessment
• Completion of baseline assessment

You may not qualify if:

• Unwilling or unable to participate in the study.
• Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study.
• Currently receiving chemotherapy.
• Prognosis less than 6 months, per the judgment of the primary oncologist.
• Medical contraindication to physical activity, as assessed by outpatient oncologist.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Yohimbine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Daniel Lage, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 6, 2023
• Study Start: August 28, 2023
• Primary Completion: December 2, 2024
• Study Completion: September 29, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)