Clinical trial NCT05487846: Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation
Official title: ADVANTAGE: Addressing Disparities for Veterans and African Americans Through Peer-Navigation for Testing and Genetic Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metastatic Prostate Carcinoma
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial evaluates whether having a trained peer navigator helps African American men with prostate cancer that has spread to other parts of the body (metastatic) understand and navigate the genetic testing process better than not having a peer navigator. Genetic testing for men with prostate cancer is very important for making treatment and management decisions. However, understanding the risks, benefits, and steps of genetic counseling and testing can be very challenging for patients. African American men are especially less likely to participant in genetic testing due to lack of awareness or understanding, cultural beliefs, finances, or mistrust of the healthcare system. A peer navigator, someone who helps a patient through the information and the process, may be helpful to some men. This study evaluates whether having a peer navigator throughout the genetic evaluation process helps patients understand and engage in the process more.

Detailed description: 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

Primary outcomes:
measure: Frequency of pretest genetic counseling engagement
timeFrame: Up to 4 years
Secondary outcomes:
measure: Mean changes in decisional conflict for genetic testing
timeFrame: Up to 4 years
measure: Mean changes in knowledge of cancer genetics
timeFrame: Up to 4 years
Other outcomes:
measure: Healthcare system distrust
timeFrame: Up to 4 years
measure: Satisfaction with the genetic evaluation process
timeFrame: Up to 4 years
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Study officials:
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