Back to resultsPeer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network
Primary Purpose
Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Training and Education
Educational Intervention
Discussion
Sponsored by
About this trial
This is an interventional supportive care trial for Metastatic Prostate Carcinoma
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
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (training, education, discussion)
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of inquiries to the central number (feasibility)
Percent of callers screened and eligible to participate (feasibility)
Percent of eligible callers who enroll in the study (feasibility)
Percent who complete the endpoint assessment (feasibility)
Number and percent of men making genetic counseling appointments
Secondary Outcome Measures
Change in decisional conflict for genetic counseling
Reported with mean and standard deviation.
Change in acceptability/attitude toward genetic counseling and testing
Reported with mean and standard deviation.
Change of genetics knowledge
Reported with mean and standard deviation
Full Information
NCT ID
NCT05627219
First Posted
November 16, 2022
Last Updated
December 13, 2022
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT05627219
Brief Title
Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network
Official Title
Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (training, education, discussion)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training and Education
Intervention Description
Undergo training and education
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive educational booklet
Intervention Type
Procedure
Intervention Name(s)
Discussion
Other Intervention Name(s)
Discuss
Intervention Description
Attend discussion with peer genetic coach
Primary Outcome Measure Information:
Title
Number of inquiries to the central number (feasibility)
Time Frame
Up to 1 year
Title
Percent of callers screened and eligible to participate (feasibility)
Time Frame
Up to 1 year
Title
Percent of eligible callers who enroll in the study (feasibility)
Time Frame
Up to 1 year
Title
Percent who complete the endpoint assessment (feasibility)
Time Frame
Up to 1 year
Title
Number and percent of men making genetic counseling appointments
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Change in decisional conflict for genetic counseling
Description
Reported with mean and standard deviation.
Time Frame
Baseline up to 1 year
Title
Change in acceptability/attitude toward genetic counseling and testing
Description
Reported with mean and standard deviation.
Time Frame
Baseline up to 1 year
Title
Change of genetics knowledge
Description
Reported with mean and standard deviation
Time Frame
Baseline up to 1 year
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veda Giri, MD
Email
veda.giri@jefferson.edu
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network
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