Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT

University of California San Diego

Status: Active, not recruiting

Conditions: Colorectal Cancer

Treatments: Diagnostic Test: Fecal Immunochemical Test; Diagnostic Test: Cologuard

Study type: Interventional

Funder types: Other

Identifiers

NCT06173375

803124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Mailed Cologuard Outreach

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Cologuard

Mailed Fecal immunochemical test Outreach

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Fecal Immunochemical Test