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OpenTrials
Completed

NCT Number: NCT05755490

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)

Completed

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PROWESS

Behavioral

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.

Primary outcomes

  1. Participant Satisfaction

    Time frame: 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 outcomes

  1. Change in Objective Physical Activity

    Time frame: At Baseline and from weeks 1 - 12

    Collected physical activity via FitBit measure of steps and activity classification.

  2. Change in Self-Reported Exercise

    Time frame: At Baseline and weeks 8-12

    Assessed by the Short-Form International Physical Activity Questionnaire (IPAQ), a self-reported measure of physical activity.

  3. Change in Participant Quality of Life

    Time frame: 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.

  4. Change in Psychological Distress Symptoms

    Time frame: 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.

  5. Change in Self-Efficacy for Managing Symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 6, 2023
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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