IMPRINT: A Pilot Study to Improve Germline Testing in At-Risk Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of a patient educational program to improve germline genetic testing for eligible patients with prostate cancer.
研究概览
简要总结
A quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.
详细描述
This is a prospective single arm quality improvement initiative for the use of a standardized educational intervention on germline testing in prostate cancer to improve the rates of germline genetic testing among patients recommended for testing. Patients who consent to the study will undergo a one-on-one education session regarding the rationale and the benefits/risks of germline testing. Following the educational session, if a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Men, age greater than or equal to 18 years of age.
- •Diagnosis of prostate cancer of any histology.
- •Must meet NCCN guidelines for germline testing
排除标准
- •Have had prior germline testing.
- •Have somatic genetic testing that is positive for a possible germline variant.
研究组 & 干预措施
Educational intervention
In-clinic or virtual educational session on germline testing in prostate cancer with a trained educator.
干预措施: Educational intervention. (Behavioral)
结局指标
主要结局
Feasibility of a patient educational program to improve germline genetic testing for eligible patients with prostate cancer.
时间窗: 1 year
Accrual rate from study activation
Rate of germline genetic testing rate among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.
时间窗: 1 year
Rate of patients agreeing to proceed with germline testing among those approached with the educational intervention.
次要结局
- Prevalence of pathogenic germline mutations in patient population(18 months)
- Patient baseline knowledge of germline testing and the change in knowledge of germline testing with the educational intervention.(18 months)
- Patient baseline attitudes towards germline testing and assess the impact of an education interventional on patient perceptions of germline testing(18 months)
- Impact of germline testing results on prostate cancer management(18 months)
研究者
Rana Mckay
Associate Professor of Medicine and Urology
University of California, San Diego