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

NCT ID: NCT05755490

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-28
• Study Completion Date: 2025-09-29

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)

Detailed Description

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

Conditions

Prostate Cancer; Prostatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PROWESS

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.

Group Type: EXPERIMENTAL

PROWESS

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daniel E Lage, MD, MSc

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Lage, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

22-609

Identifier Type: -

Identifier Source: org_study_id