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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Prostatic Neoplasms; Prostate Cancer
• Intervention / Treatment: Behavioral: PROWESS

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Lage, MD; Phone Number: 617-726-5130; Email: dlage@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Massachusetts General Hospital Cancer Center
      • Contact: Daniel Lage, MD; Phone Number: 617-726-5130; Email: dlage@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Diagnosed with prostate cancer.
• Has been on androgen deprivation therapy (ADT) for at least three months, and planned to continue ADT as of last clinic visit.
• 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.
• Access to a smartphone or a computer with USB Bluetooth adapter.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 12-14 (intervention completion)

Secondary Outcome Measures

Outcome Measure	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 6 - 14
Change in Self-Reported Exercise	Assessed by the International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity.	At Baseline and weeks 12-14
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 12-14
Change in Participant Distress	Assessed by the Hospital Anxiety and Depression scale (HADS), a 14-item measure with two separate subscales to evaluate symptoms of anxiety and depression.	At Baseline and weeks 12-14

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Daniel Lage, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Estimate): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Prostate Cancer; Cognitive Behavioral Therapy; Androgen Deprivation Therapy; ADT; Prostatic Neoplasms; CBR
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 22-609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No