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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05755490
• Other study ID #: 22-609
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Massachusetts General Hospital
• Contact: Daniel Lage, MD
• Phone: 617-726-5130
• Email: dlage[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Objective Physical Activity	Collected physical activity via FitBit measure of steps and activity classification.	At Baseline and from weeks 6 - 14
Secondary	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
Secondary	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
Secondary	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