Clinical trial NCT05627219: Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network
Official title: Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Prostate Carcinoma
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men who have experience with both prostate cancer (PCA) and genetic counseling and testing, as well as peer education or navigation experience. African American men with a history of prostate cancer or with a strong family history of prostate cancer, breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer, uterine cancer, renal cancer, urothelial cancer, or upper bowel cancer.

Brief summary: This trial evaluates whether a network of peer genetic coaches is useful for addressing disparities in genetic testing and screening among African American men with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). While genetic testing has become central to prostate cancer care, African American men are less likely seek testing due to lack of awareness, cultural beliefs, financial limitations, fear of discrimination, and mistrust in the healthcare system. A network of peer genetic coaches may help address barriers, beliefs, and needs of African American men in the community and provide navigation to increase engagement in genetic testing.

Detailed description: PRIMARY OBJECTIVES:

I. Identify and train 6 African American (AA) men as peer genetic coaches (PGCs) for the Extending Prostate Genetic Awareness, Navigation, and Delivery (EXPAND) Network. (Train peer genetic coaches) II. Conduct a feasibility study of peer genetic coaching. (Provide individual coaching)

SECONDARY OBJECTIVE:

I. Patient-related outcomes will include change in decisional conflict for genetic counseling, acceptability/attitude toward genetic counseling and testing, and change of genetics knowledge.

OUTLINE:

AIM 1: Peer genetic coaches undergo training and education on study.

AIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study.

Eligibility criteria: Inclusion Criteria:

* AIM 1: Are 18 years old or older
* AIM 1: Are able to read and speak English comfortably
* AIM 1: Men who have experience with both prostate cancer (PCA) and genetic counseling and testing will be a priority for training, as well as men who have considerable peer education or navigation experience
* AIM 2: Are 18 years old or older
* AIM 2: Are African American
* AIM 2: Are able to read and speak English comfortably
* AIM 2: Men who meet any one of the following criteria: (1) metastatic prostate cancer; (2) prostate cancer with high-risk features (T3 or higher, Gleason 8 or higher, node positive disease); (3) with or without a diagnosis of prostate cancer with strong family history (2 or more first-degree or second-degree relatives) with prostate cancer (particularly metastatic prostate cancer or died from prostate cancer), breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer, uterine cancer, renal cancer, urothelial cancer, or upper bowel cancer

Exclusion Criteria:

* Patients that do not meet the inclusion criteria
* Children under the age of 18
* Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process

Primary outcomes:
measure: Number of inquiries to the central number (feasibility)
timeFrame: Up to 1 year
measure: Percent of callers screened and eligible to participate (feasibility)
timeFrame: Up to 1 year
measure: Percent of eligible callers who enroll in the study (feasibility)
timeFrame: Up to 1 year
measure: Percent who complete the endpoint assessment (feasibility)
timeFrame: Up to 1 year
measure: Number and percent of men making genetic counseling appointments
timeFrame: Up to 1 year
Secondary outcomes:
measure: Change in decisional conflict for genetic counseling
timeFrame: Baseline up to 1 year
measure: Change in acceptability/attitude toward genetic counseling and testing
timeFrame: Baseline up to 1 year
measure: Change of genetics knowledge
timeFrame: Baseline up to 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Amy Leader, DrPh, MPH
role: PRINCIPAL_INVESTIGATOR
References: