Clinical trial · Interventional
PROWESS (PROstate Cancer Wearables Exercise and Structured Supports): A Pilot Supportive Care Intervention
NCT05755490CI-TRIAL-00096137completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PROWESS | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PROWESS
- 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.
- interventionNames
- Behavioral: PROWESS
Primary outcomes (1)
- measure
- Participant Satisfaction
- timeFrame
- At week 8-12 (intervention completion)
- description
- 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 (5)
- measure
- Change in Objective Physical Activity
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.