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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05487846
Other study ID # 21F.686
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 14, 2024
Est. completion date May 31, 2026

Study information

Verified date November 2023
Source Thomas Jefferson University
Contact Veda Giri, MD
Phone 215-503-5253
Email veda.giri@jefferson.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial evaluates whether having a trained peer navigator helps African American men with prostate cancer that has spread to other parts of the body (metastatic) understand and navigate the genetic testing process better than not having a peer navigator. Genetic testing for men with prostate cancer is very important for making treatment and management decisions. However, understanding the risks, benefits, and steps of genetic counseling and testing can be very challenging for patients. African American men are especially less likely to participant in genetic testing due to lack of awareness or understanding, cultural beliefs, finances, or mistrust of the healthcare system. A peer navigator, someone who helps a patient through the information and the process, may be helpful to some men. This study evaluates whether having a peer navigator throughout the genetic evaluation process helps patients understand and engage in the process more.


Description:

PRIMARY OBJECTIVES: I. Develop a peer-based navigation program for African American (AA) men with prostate cancer (PCA). II. Conduct a pilot study of peer-navigated genetic evaluation vs. standard clinical care and assess feasibility of peer navigation. SECONDARY OBJECTIVE: I. Evaluating the intervention effects on decisional conflict and PCA genetics knowledge. EXPLORATORY OBJECTIVE: I. Assessing trust of the healthcare system and satisfaction with the genetic evaluation process. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive assistance from a peer navigator during genetic evaluation processes. Peer navigators help patients schedule counseling appointments, discuss questions and concerns about testing, assist in saliva collection, schedule a post-test disclosure visit, and do a results and recommendations debrief. ARM II: Patients receive standard care during genetic evaluation processes. Patients receive genetic counseling, undergo genetic testing, schedule a post-test disclosure visit, and receive their genetic test results and recommendations per standard care.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date May 31, 2026
Est. primary completion date April 7, 2026
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Provide signed and dated informed consent form - English speaking only - Willing to comply with all study procedures and be available for the duration of the study - Any individual >= 18 years old - African American men who meet National Comprehensive Cancer Network (NCCN) criteria for testing will be offered participation. These criteria include any one of the following: (1) metastatic prostate cancer (PCA); (2) intraductal or ductal pathology; (3) T3a or higher; (4) grade group 4 or Gleason 8 or higher; (5) family history of breast, ovarian, prostate, pancreatic, colorectal, or uterine cancers in 3 or more blood relatives particularly if diagnosed at age < 50. These criteria have been adapted from the NCCN Prostate Cancer (version 2.2021) and NCCN Breast, Ovarian, and Pancreatic (version 2.2021) guideline Exclusion Criteria: - Patients that do not meet the inclusion criteria and children under the age of 18 will be excluded - Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Patient Navigation
Receive peer navigation services
Other:
Genetic Counseling
Receive genetic counseling
Survey Administration
Ancillary studies
Best Practice
Receive standard care
Genetic Counseling
Receive genetic counseling
Survey Administration
Ancillary studies

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Outcome

Type Measure Description Time frame Safety issue
Other Healthcare system distrust Compared between two study arms. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Up to 4 years
Other Satisfaction with the genetic evaluation process Compared between two study arms. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Up to 4 years
Primary Frequency of pretest genetic counseling engagement Compared between randomized study groups. Tested using a chi-square test. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Up to 4 years
Secondary Mean changes in decisional conflict for genetic testing Compared between study groups over time. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Evaluated using mixed effects models with fixed effects for group indicator, time, and group-by-time interaction and random intercept effects for individual. Up to 4 years
Secondary Mean changes in knowledge of cancer genetics Compared between study groups over time. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Evaluated using mixed effects models with fixed effects for group indicator, time, and group-by-time interaction and random intercept effects for individual. Up to 4 years
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