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

Mass General Brigham

Status: Completed

Conditions: Prostatic Neoplasms; Prostate Cancer

Treatments: Behavioral: PROWESS

Study type: Interventional

Funder types: Other

Identifiers

NCT05755490

22-609

Details and patient eligibility

About

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)

Full 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

Enrollment: 14 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

PROWESS

Experimental group

Description:

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.

Treatment:

Behavioral: PROWESS