Trial of Community Health Worker-led Decision Coaching (NCT03726320) | Clinical Trial Compass
CompletedNot Applicable
Trial of Community Health Worker-led Decision Coaching
United States162 participantsStarted 2019-10-15
Plain-language summary
Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the U.S. This randomized trial will evaluate the efficacy of a Community Health Worker-led decision coaching program to facilitate Shared Decision Making (SDM) and Prostate Specific Antigen (PSA) screening among Black men with regards to decision quality, the decision making process, patient-provider communication and PSA utilization for Black men in the primary care setting.
Who can participate
Age range
40 Years – 69 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients:
* Black
* Male
* Attending FQHC for routine primary care appointment
Providers:
* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
* Caring for patients that fit inclusion criteria
Exclusion Criteria:
* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC)
* Caring for patients that fit inclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prostate Specific Antigen (PSA) Screening Rates
Timeframe: Up to Month 3
2
Patient Knowledge Survey Score
Timeframe: Day 1
3
Decision Quality Score
Timeframe: Day 1
4
Percentage of Participants Who Make Informed Choice