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

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer; Prostatic Neoplasms
• Interventions: Behavioral: PROWESS

• Registration Number: NCT05755490
• Lead Sponsor: Massachusetts General Hospital

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

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-06
• Study Start: 2023-08-28
• Status Verified: 2024-12
• Primary Completion: 2024-12-02
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PROWESS	PROWESS	Participants will complete study procedures as outlined: * Wear FitBit watch during the 12-week study period. * Group intervention sessions, in-person or virtually. * Two, optional follow-up sessions. * One-on-one, semi-structured interview with trained study staff to assess participant experience with intervention.

Primary Outcome Measures

Name	Time	Method
Participant Satisfaction	At week 8-12 (intervention completion)	Assessed by the Client Satisfaction Questionnaire-3 (CSQ), a 3-item survey with answers ranging from 1-4, "quite dissatisfied" to "very satisfied."

Secondary Outcome Measures

Name	Time	Method
Change in Objective Physical Activity	At Baseline and from weeks 1 - 12	Collected physical activity via FitBit measure of steps and activity classification.
Change in Self-Reported Exercise	At Baseline and weeks 8-12	Assessed by the Short-Form International Physical Activity Questionnaire (IPAQ), a self-reported measure of physical activity.
Change in Participant Quality of Life	At Baseline and weeks 8-12	Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), which consists of five subscales assessing physical, functional, emotional, social wellbeing.
Change in Psychological Distress Symptoms	At Baseline and weeks 8-12	Assessed by the Patient Health Questinnaire-4, a 4-item measure with two separate subscales to evaluate symptoms of anxiety and depression.
Change in Self-Efficacy for Managing Symptoms	At Baseline and weeks 8-12	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.

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States