Efforts to Enhance Germline Genetic Testing at Lyndon B. Johnson Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
This clinical trial identifies factors associated with completing genetic testing, aids in the development of a decision support tool, and tests how well the decision support tool works to enhance germline genetic testing in patients with prostate cancer. Germline genetic testing is a guideline-recommended standard of care for many patients with prostate cancer. Completing genetic testing can enable the use of targeted therapies, offers access to novel clinical trials, provides valuable information, and can help identify at risk family members. The decision support tool may educate patients and assist in the decision to engage with germline genetic testing.
详细描述
PRIMARY OBJECTIVES:
I. Identify patient, provider, and health system factors contributing to the completion of recommended germline testing for men with prostate cancer.
II. Develop a decision support tool for patients tailored to the cultural and socioeconomic context of the local community.
III. Conduct a pilot intervention trial to evaluate a point-of-care decision support tool in a public safety net hospital in Harris County, Texas.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Diagnosed prostate cancer patients receiving care at Lyndon B. Johnson (LBJ) Hospital
- •Were recommended for germline genetic testing by their oncology provider
- •Can provide informed consent
- •Can communicate in English or Spanish
排除标准
- •Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition
研究组 & 干预措施
Group 1 (Qualitative interview)
Patients complete a qualitative interview that informs the development of the decision support tool.
干预措施: Electronic Health Record Review (Other)
Group 1 (Qualitative interview)
Patients complete a qualitative interview that informs the development of the decision support tool.
干预措施: Interview (Other)
Group 2 (Draft decision support tool, cognitive interview)
Patients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study.
干预措施: Behavioral Intervention (Behavioral)
Group 2 (Draft decision support tool, cognitive interview)
Patients view the draft of the decision support tool and complete cognitive interviews for the refinement of the decision support tool on study.
干预措施: Interview (Other)
Group 3 (Decision tool)
Patients view the decision support tool that provides culturally tailored information about genetic testing and the collection process. Patients may then provide a blood sample for standard of care genetic testing and may additionally meet with a genetics counselor for additional information prior to testing. Patients with a positive germline genetic mutation will discuss results with a genetics counselor.
干预措施: Behavioral Intervention (Behavioral)
Group 3 (Decision tool)
Patients view the decision support tool that provides culturally tailored information about genetic testing and the collection process. Patients may then provide a blood sample for standard of care genetic testing and may additionally meet with a genetics counselor for additional information prior to testing. Patients with a positive germline genetic mutation will discuss results with a genetics counselor.
干预措施: Biospecimen Collection (Procedure)
Group 3 (Decision tool)
Patients view the decision support tool that provides culturally tailored information about genetic testing and the collection process. Patients may then provide a blood sample for standard of care genetic testing and may additionally meet with a genetics counselor for additional information prior to testing. Patients with a positive germline genetic mutation will discuss results with a genetics counselor.
干预措施: Genetic Counseling (Other)
Group 3 (Decision tool)
Patients view the decision support tool that provides culturally tailored information about genetic testing and the collection process. Patients may then provide a blood sample for standard of care genetic testing and may additionally meet with a genetics counselor for additional information prior to testing. Patients with a positive germline genetic mutation will discuss results with a genetics counselor.
干预措施: Genetic Testing (Other)
Group 3 (Decision tool)
Patients view the decision support tool that provides culturally tailored information about genetic testing and the collection process. Patients may then provide a blood sample for standard of care genetic testing and may additionally meet with a genetics counselor for additional information prior to testing. Patients with a positive germline genetic mutation will discuss results with a genetics counselor.
干预措施: Survey Administration (Other)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点