Peer navigation to support African American men with metastatic prostate cancer during genetic testing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized pilot compares a peer-navigated genetic evaluation pathway to standard genetic counseling for African American men meeting NCCN criteria for testing. Participants are assigned to either a peer navigator who assists with scheduling, answers questions, aids with saliva collection, and provides result debriefing, or to standard-of-care genetic counseling and testing. The primary goals are to develop the peer-navigation program and determine feasibility of delivering navigation in this population. Secondary and exploratory measures include effects on decisional conflict, genetics knowledge, trust in the healthcare system, and satisfaction with the process.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provide signed and dated informed consent form
* English speaking only
* Willing to comply with all study procedures and be available for the duration of the study
* Any individual \>= 18 years old
* African American men who meet National Comprehensive Cancer Network (NCCN) criteria for testing will be offered participation. These criteria include any one of the following: (1) metastatic prostate cancer (PCA); (2) intraductal or ductal pathology; (3) T3a or higher; (4) grade group 4 or Gleason 8 or higher; (5) family history of breast, ovarian, prostate, pancreatic, colorectal, or uterine cancers in 3 or more blood relatives particularly if diagnosed at age \< 50. These criteria have been adapted from the NCCN Prostate Cancer (version 2.2021) and NCCN Breast, Ovarian, and Pancreatic (version 2.2021) guideline

Exclusion Criteria:

* Patients that do not meet the inclusion criteria and children under the age of 18 will be excluded
* Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded

Where it's running

• Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Amy Leader, DrPH, MPH — Thomas Jefferson University
• Study coordinator: Amy Leader, DrPH, MPH
• Email: Amy.leader@jefferson.edu
• Phone: 215-955-7739

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.