Head to Head Mailed Cologuard to Mailed FIT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: Cologuard
* Diagnostic Test: Fecal Immunochemical Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm intervention trial comparing mailed Cologuard outreach (intervention) to mailed FIT outreach (control)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mailed Cologuard Outreach<br>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. | Diagnostic Test: Cologuard<br>* Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.<br>|
| Active Comparator: Mailed Fecal immunochemical test Outreach<br>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. | Diagnostic Test: Fecal Immunochemical Test<br>* Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.<br>* Other names: OC-Sensor Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Colorectal cancer screening completion | 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) | Within 3 months of randomization | 
| Proportion of Abnormal stool blood test results | Among those completing designed interventions (Cologuard or FIT), the proportion of test results yielding an abnormal result. | Within 3 months of randomization | 
| Proportion of Follow-up colonoscopy after abnormal stool blood test result | Among those with positive stool blood test results, the proportion who complete diagnostic follow-up colonoscopy | Within 6 months after stool blood test completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants opting out of the pilot | Measurement of feasibility of pilot | Within 3 months of randomization | 
| Number of participants with undeliverable FIT or Cologuard tests (mail fail rate) | Measurement of feasibility of mailed outreach | Within 3 months of randomization | 
| Number of Adenomas detected | Measurement of number of adenomas detected during study period | Within 6 months after screening test completion | 
| Number of sessile serrated lesions detected | Measurement of number of sessile serrated lesions detected during study period | Within 6 months after screening test completion | 
| Number of colorectal cancer cases detected | Number of colorectal cancers detected during study period | Within 6 months after screening test completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, early detection, stool blood test