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Recruiting NCT05627219

Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network

— Observational Metastatic Prostate Carcinoma Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Training and Education, Educational Intervention, Discussion.
Who it may be relevant to
Registry conditions: Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network

Overview

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.

Interventions

  • Behavioral Training and Education
    Undergo training and education
  • Other Educational Intervention
    Receive educational booklet
  • Procedure Discussion
    Attend discussion with peer genetic coach

Primary outcome measures

  • Number of inquiries to the central number (feasibility) [Time frame: Up to 1 year]
  • Percent of callers screened and eligible to participate (feasibility) [Time frame: Up to 1 year]
  • Percent of eligible callers who enroll in the study (feasibility) [Time frame: Up to 1 year]
  • Percent who complete the endpoint assessment (feasibility) [Time frame: Up to 1 year]
  • Number and percent of men making genetic counseling appointments [Time frame: Up to 1 year]
Secondary outcome measures (3)
  • Change in decisional conflict for genetic counseling [Time frame: Baseline up to 1 year]
  • Change in acceptability/attitude toward genetic counseling and testing [Time frame: Baseline up to 1 year]
  • Change of genetics knowledge [Time frame: Baseline up to 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Identifiers

NCT: NCT05627219 · 22C.423 · JT 22046

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗