Comparative Effectiveness Pilot Trial of Mailed Cologuard Outreach to Mailed FIT Outreach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Proportion of Colorectal cancer screening completion
研究概览
简要总结
The objective of this pilot study is to compare the effectiveness of mailed outreach of two stool based tests, Cologuard and the fecal immunochemical test (FIT) in screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.
详细描述
Adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. Eligible participants will be randomized to either mailed Cologuard outreach, facilitated by Exact Sciences or mailed FIT outreach. Colorectal cancer screening completion within 3 months will be measured as the primary outcome, in addition to secondary recruitment and intervention-based feasibility outcomes to demonstrate the potential for a larger randomized controlled trial.
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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 45-49 with EHR documentation indicating that the patient has an assigned primary care provider at UCSD Health
- •≥1 UCSD Health System health visit within the last year
- •Resides in San Diego or Imperial County
- •Currently not up to date with CRC screening
- •Insured by private, public or other health insurance.
排除标准
- •Up-to-date with screening
- •Prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer.
- •Prior history of colectomy
- •Lack of health insurance
研究组 & 干预措施
Mailed Cologuard Outreach
Receipt of mailed Cologuard test for colorectal cancer screening to be completed and returned by participant. If test is negative, participant will be advised to undergo another test in 3 years. If test is positive, participant will be advised to schedule colonoscopy for further testing.
干预措施: Cologuard (Diagnostic Test)
Mailed Fecal immunochemical test Outreach
Receipt of mailed FIT for colorectal cancer screening to be completed and returned by participant. If test is negative, participant will be advised to undergo another test in 1 year. If test is positive, participant will be advised to schedule colonoscopy for further testing.
干预措施: Fecal Immunochemical Test (Diagnostic Test)
结局指标
主要结局
Proportion of Colorectal cancer screening completion
时间窗: Within 3 months of randomization
The proportion of individuals who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)
Proportion of Abnormal stool blood test results
时间窗: Within 3 months of randomization
Among those completing designed interventions (Cologuard or FIT), the proportion of test results yielding an abnormal result.
Proportion of Follow-up colonoscopy after abnormal stool blood test result
时间窗: Within 6 months after stool blood test completion
Among those with positive stool blood test results, the proportion who complete diagnostic follow-up colonoscopy
次要结局
- Number of participants opting out of the pilot(Within 3 months of randomization)
- Number of participants with undeliverable FIT or Cologuard tests (mail fail rate)(Within 3 months of randomization)
- Number of Adenomas detected(Within 6 months after screening test completion)
- Number of sessile serrated lesions detected(Within 6 months after screening test completion)
- Number of colorectal cancer cases detected(Within 6 months after screening test completion)
研究者
Joshua Demb, PhD, MPH
Postdoctoral Scholar
University of California, San Diego