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Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation

NCT05487846 · Thomas Jefferson University
In plain English

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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
Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation · TrialPath