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Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation
NCT05487846 · Thomas Jefferson University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
ADVANTAGE: Addressing Disparities for Veterans and African Americans Through Peer-Navigation for Testing and Genetic Evaluation
About this study
PRIMARY OBJECTIVES:
I. Develop a peer-based navigation program for African American (AA) men with prostate cancer (PCA).
II. Conduct a pilot study of peer-navigated genetic evaluation vs. standard clinical care and assess feasibility of peer navigation.
SECONDARY OBJECTIVE:
I. Evaluating the intervention effects on decisional conflict and PCA genetics knowledge.
EXPLORATORY OBJECTIVE:
I. Assessing trust of the healthcare system and satisfaction with the genetic evaluation process.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive assistance from a peer navigator during genetic evaluation processes. Peer navigators help patients schedule counseling appointments, discuss questions and concerns about testing, assist in saliva collection, schedule a post-test disclosure visit, and do a results and recommendations debrief.
ARM II: Patients receive standard care during genetic evaluation processes. Patients receive genetic counseling, undergo genetic testing, schedule a post-test disclosure visit, and receive their genetic test results and recommendations per standard care.
Eligibility criteria
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
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-01
Estimated completion: 2026-09
Last updated: 2026-04-14
Interventions
Behavioral: Patient NavigationOther: Genetic CounselingOther: Survey AdministrationOther: Best PracticeOther: Genetic CounselingOther: Survey Administration
Primary outcomes
- • Frequency of pretest genetic counseling engagement (Up to 4 years)
Sponsor
Thomas Jefferson University · other
Contacts & investigators
ContactAmy Leader, DrPH, MPH · contact · Amy.leader@jefferson.edu · 215-955-7739
InvestigatorAmy Leader, DrPH, MPH · principal_investigator, Thomas Jefferson University
All locations (1)
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States