Clinical trial · Interventional
Trial of Community Health Worker-led Decision Coaching
Randomized Trial of Community Health Worker-led Decision Coaching to Promote Shared Decision Making for Prostate Cancer Screening Among Black Male Patients and Their Providers
- 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)
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.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Education Counseling Session for PSA Screening | Behavioral | — | UNRESOLVED |
| General Health Counseling Coaching | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- A decision aid along with decision coaching on PSA screening from a Community Health Worker (CHW). The intervention will be administered directly prior to the participant's appointment with their provider.
- interventionNames
- Behavioral: Education Counseling Session for PSA Screening
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- A decision aid along with CHW interaction on dietary and lifestyle modification to serve as an attention control. The intervention will be administered directly prior to the participant's appointment with their provider.
- interventionNames
- Behavioral: General Health Counseling Coaching
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMakarov DV, Feuer Z, Ciprut S, Lopez NM, Fagerlin A, Shedlin M, Gold HT, Li H, Lynch G, Warren R, Ubel P, Ravenell JE. Randomized trial of community health worker-led decision coaching to promote shared decision-making for prostate cancer screening among Black male patients and their providers. Trials. 2021 Feb 10;22(1):128. doi: 10.1186/s13063-021-05064-4. PMID 33568208