Comparative Effectiveness Pilot Trial of Mailed Cologuard Outreach to Mailed FIT Outreach
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- University of California, San Diego
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Proportion of Colorectal cancer screening completion
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
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 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.
Investigators
Joshua Demb, PhD, MPH
Postdoctoral Scholar
University of California, San Diego
Eligibility Criteria
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
Outcomes
Primary Outcomes
Proportion of Colorectal cancer screening completion
Time Frame: 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
Time Frame: 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
Time Frame: Within 6 months after stool blood test completion
Among those with positive stool blood test results, the proportion who complete diagnostic follow-up colonoscopy
Secondary Outcomes
- 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)