ADVANTAGE: Addressing Disparities for Veterans and African Americans Through Peer-Navigation for Testing and Genetic Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Frequency of pretest genetic counseling engagement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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 <
- •These criteria have been adapted from the NCCN Prostate Cancer (version 2.2021) and NCCN Breast, Ovarian, and Pancreatic (version 2.2021) guideline
排除标准
- •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
研究组 & 干预措施
Arm I (peer navigation)
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.
干预措施: Genetic Counseling (Other)
Arm II (best practice)
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.
干预措施: Best Practice (Other)
Arm I (peer navigation)
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.
干预措施: Patient Navigation (Behavioral)
Arm I (peer navigation)
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.
干预措施: Survey Administration (Other)
Arm II (best practice)
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.
干预措施: Genetic Counseling (Other)
Arm II (best practice)
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.
干预措施: Survey Administration (Other)
结局指标
主要结局
Frequency of pretest genetic counseling engagement
时间窗: Up to 4 years
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.
次要结局
- Mean changes in decisional conflict for genetic testing(Up to 4 years)
- Mean changes in knowledge of cancer genetics(Up to 4 years)