Study of Colorectal Cancer Screening Options
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,004
- 试验地点
- 2
- 主要终点
- Assess Colorectal Cancer Screening Completion
研究概览
简要总结
The investigators propose to evaluate Guardant Health's commercially available colorectal cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC screening.
详细描述
The investigators propose to evaluate Guardant Health's commercially available colorectal cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC screening.
Primary Objective (or Aim) Assess colorectal cancer screening completion among patients who are non-adherent after receiving stool test outreach, who have an upcoming clinical appointment, and who are offered a commercially available colorectal cancer blood test versus usual care (i.e. reminder to complete stool testing during their clinical appointment).
Secondary Objectives (or Aim) Assess patients' and providers' perceived confidence in the test (based on available test performance characteristics) and willingness to obtain/offer the test on an on-going basis, based on qualitative interviews; assess preliminary rates of follow-up colonoscopy completion (after an initial abnormal test result) among participants allocated to the blood test vs. usual care condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45-75
- •Received a FIT test in the last 3-9 months yet did not return their FIT
- •Upcoming appointment or willing to reschedule an appointment at KPNW within 2 - 6 weeks
- •Able and willing to provide informed consent if in the intervention arm
排除标准
- •On KPNW's do not contact list
- •Having a legal authorized representative
- •Non-English speakers
结局指标
主要结局
Assess Colorectal Cancer Screening Completion
时间窗: Within 3 months of patient identification
Assess the percentage who received any CRC screening test (blood draw, FIT or FIT-DNA, or flexible sigmoidoscopy or colonoscopy) within 3 months of eligibility determination among eligible individuals in the blood test and usual care groups.
次要结局
- Assess the Percentage of Participants Who Completed Follow-up Testing.(Within 6 months of abnormal FIT test)