N/A
N=146
Trial of Community Health Worker-led Decision Coaching
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03726320 ↗Enrolled (actual)
146
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Prostate Specific Antigen (PSA) Screening Rates — 77.8; 76.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education Counseling Session for PSA Screening (Behavioral); General Health Counseling Coaching (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- NYU Langone Health
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prostate Specific Antigen (PSA) Screening Rates |
77.8; 76.7 | — |
| PRIMARY Patient Knowledge Survey Score |
8.13; 5.23 | — |
| PRIMARY Decision Quality Score |
11.2; 10.8 | — |
| PRIMARY Percentage of Participants Who Make Informed Choice |
64.8; 43.3 | — |
| SECONDARY Decision Self-Efficacy Scale Score |
96; 94.7 | — |
| SECONDARY Doctor-Patient Communication Survey Score |
4.28; 4.31 | — |
| SECONDARY Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score |
47.5; 47.3 | — |
| SECONDARY Change in Decisional Conflict Scale Score |
17; 21.9 | — |
| SECONDARY Satisfaction With Decision Scale Score |
4.48; 4.31 | — |
| SECONDARY Decisional Regret Scale Survey |
21.2; 27 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03726320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.