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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05755490

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostatic Neoplasms	Behavioral: PROWESS	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Participant Satisfaction [At week 12-14 (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

Change in Objective Physical Activity [At Baseline and from weeks 6 - 14]
Collected physical activity via FitBit measure of steps and activity classification.
Change in Self-Reported Exercise [At Baseline and weeks 12-14]
Assessed by the International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity.
Change in Participant Quality of Life [At Baseline and weeks 12-14]
Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), which consists of five subscales assessing physical, functional, emotional, social wellbeing.
Change in Participant Distress [At Baseline and weeks 12-14]
Assessed by the Hospital Anxiety and Depression scale (HADS), a 14-item measure with two separate subscales to evaluate symptoms of anxiety and depression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.