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| ID | Type | Description | Link |
|---|---|---|---|
| JT 17263 | Other Identifier | JeffTrial Number | |
| PC200282 | Other Grant/Funding Number | DOD |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (peer navigation) | Experimental | 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 sample collection, schedule a post-test disclosure visit, and do a results and recommendations debrief. |
|
| Arm II (best practice) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigation | Behavioral | Receive peer navigation services |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Leader, DrPH, MPH | Contact | 215-955-7739 | Amy.leader@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amy Leader, DrPH, MPH | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Genetic Counseling | Other | Receive genetic counseling |
|
| Survey Administration | Other | Ancillary studies |
|
| Best Practice | Other | Receive standard care |
|
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| Genetic Counseling | Other | Receive genetic counseling |
|
| Survey Administration | Other | Ancillary studies |
|
| Up to 4 years |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| D005817 | Genetic Counseling |
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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