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Behavioural Intervention
PROWESS Supportive Care for Prostate Cancer
N/A
Waitlist Available
Led By Daniel Lage, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and weeks 12-14
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to improve quality of life for Black & Hispanic/Latino prostate cancer patients through exercise, reduced side effects of ADT & health behavior change tools.
Who is the study for?
The PROWESS trial is for Black and Hispanic/Latino men over 18 with prostate cancer, who've been on ADT for at least three months. Participants should exercise less than 150 minutes per week, have access to a smartphone or computer with Bluetooth, and be fluent in English or Spanish. Those with significant health issues preventing informed consent, current chemotherapy treatment, short prognosis, or unable to do physical activity are excluded.
What is being tested?
PROWESS is a behavioral change intervention aimed at increasing exercise among participants to reduce side effects from ADT and improve their quality of life. It involves using wearable technology and structured support tools integrated into the participant's healthcare routine.
What are the potential side effects?
Since PROWESS focuses on behavior change rather than medication, typical drug-related side effects aren't expected. However, increased physical activity could lead to muscle soreness or strain especially if participants are not accustomed to regular exercise.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and weeks 12-14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and weeks 12-14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Participant Satisfaction
Secondary study objectives
Change in Objective Physical Activity
Change in Participant Distress
Change in Participant Quality of Life
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PROWESSExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,001 Previous Clinical Trials
13,308,586 Total Patients Enrolled
35 Trials studying Prostate Cancer
3,668 Patients Enrolled for Prostate Cancer
Daniel Lage, MDPrincipal InvestigatorMassachusetts General Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a smartphone or a computer with a USB Bluetooth adapter to participate.You identify as Black or Hispanic/Latino.You are able to speak English or Spanish fluently.Your primary oncologist thinks that you have less than 6 months to live.
Research Study Groups:
This trial has the following groups:- Group 1: PROWESS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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