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.
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.
Number of Participants Agreeing to Proceed With Germline Testing Among Those Approached With the Educational Intervention.
时间窗: Within 1 year
Germline genetic testing among adult prostate cancer patients who are recommended to receive germline testing per NCCN guidelines.
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)
- Patient Baseline Knowledge of Germline Testing(Baseline)
- Patient Attitudes Towards Germline Testing and Assess the Impact of an Education Interventional on Patient Perceptions of Germline Testing(Within 18 months)
- Number of Participants With Pathogenic Germline Mutations(within 18 months)
- Patient Knowledge of Germline Testing After the Educational Intervention.(within 18 months)
研究者
Rana Mckay
Associate Professor of Medicine and Urology
University of California, San Diego