Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Proportion of Colorectal cancer screening completion
Study Overview
Brief Summary
The objective of this study is to measure the comparative effectiveness of mailed outreach of two stool based tests, multi-target stool DNA (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.
Detailed Description
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 12 months of randomization will be measured as the primary outcome, in addition to secondary outcomes of Cologuard or FIT positivity rate measured within 12 months of randomization, and follow-up colonoscopy uptake and CRC incidence, measured within 24 months of randomization.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 49 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: Fecal Immunochemical Test (Diagnostic Test)
Outcomes
Primary Outcomes
Proportion of Colorectal cancer screening completion
Time Frame: Within 12 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)
Secondary Outcomes
- Proportion of Abnormal stool blood test results(Within 12 months of randomization)
- Proportion of Follow-up colonoscopy after abnormal stool blood test result(Within 24 months after randomization)
- Colorectal cancer incidence(Within 24 months after randomization)
Investigators
Joshua Demb, PhD, MPH
Assistant Professor
University of California, San Diego