To hear about similar clinical trials, please enter your email below
Trial Title:
Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network
NCT ID:
NCT05627219
Condition:
Metastatic Prostate Carcinoma
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Training and Education
Description:
Undergo training and education
Arm group label:
Supportive care (training, education, discussion)
Intervention type:
Other
Intervention name:
Educational Intervention
Description:
Receive educational booklet
Arm group label:
Supportive care (training, education, discussion)
Other name:
Education for Intervention
Other name:
Intervention by Education
Other name:
Intervention through Education
Other name:
Intervention
Other name:
Educational
Intervention type:
Procedure
Intervention name:
Discussion
Description:
Attend discussion with peer genetic coach
Arm group label:
Supportive care (training, education, discussion)
Other name:
Discuss
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Male
Gender based:
Yes
Gender description:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Leader, DrPh, MPH
Phone:
215-955-7739
Email:
amy.leader@jefferson.edu
Investigator:
Last name:
Amy Leader, DrPh, MPH
Email:
Principal Investigator
Start date:
June 3, 2024
Completion date:
April 29, 2026
Lead sponsor:
Agency:
Thomas Jefferson University
Agency class:
Other
Source:
Thomas Jefferson University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05627219
