About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Patient Navigation
BehavioralReceive peer navigation services
Genetic Counseling
Other interventionReceive genetic counseling
Survey Administration
Other interventionAncillary studies
Best Practice
Other interventionReceive standard care
Genetic Counseling
Other interventionReceive genetic counseling
Survey Administration
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Other outcomes
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.
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.
Sponsors and contacts
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