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

January 4, 2024 updated by: Thomas Jefferson University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Sidney Kimmel Cancer Center at Thomas Jefferson University
        • Contact:
        • Principal Investigator:
          • Amy Leader, DrPh, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Supportive care (training, education, discussion)

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.
Behavioral: Training and Education
Undergo training and education
Other: Educational Intervention
Receive educational booklet
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention
  • Educational
Procedure: Discussion
Attend discussion with peer genetic coach
Other Names:
  • Discuss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of inquiries to the central number (feasibility)
Time Frame: Up to 1 year
Up to 1 year
Percent of callers screened and eligible to participate (feasibility)
Time Frame: Up to 1 year
Up to 1 year
Percent of eligible callers who enroll in the study (feasibility)
Time Frame: Up to 1 year
Up to 1 year
Percent who complete the endpoint assessment (feasibility)
Time Frame: Up to 1 year
Up to 1 year
Number and percent of men making genetic counseling appointments
Time Frame: Up to 1 year
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in decisional conflict for genetic counseling
Time Frame: Baseline up to 1 year
Reported with mean and standard deviation.
Baseline up to 1 year
Change in acceptability/attitude toward genetic counseling and testing
Time Frame: Baseline up to 1 year
Reported with mean and standard deviation.
Baseline up to 1 year
Change of genetics knowledge
Time Frame: Baseline up to 1 year
Reported with mean and standard deviation
Baseline up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Amy Leader, DrPh, MPH, Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2024

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

November 16, 2022

First Posted (Actual)

November 25, 2022

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22C.423

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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