Head to Head Trial of Mailed Cologuard to Mailed FIT

N/AEnrolling By InvitationNCT06931860

University of California, San Diego400 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

400

Conditions

Colorectal Cancer Screening Fecal Immunochemical Test Multi-target Stool DNA Colorectal Cancer (CRC)

Interventions

CologuardDIAGNOSTIC_TEST

Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.

Fecal Immunochemical TestDIAGNOSTIC_TEST

Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 49 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

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)

Time frame: Within 12 months of randomization

Secondary Outcomes

Proportion of Abnormal stool blood test results

Among those completing designed interventions (Cologuard or FIT), the proportion of test results yielding an abnormal result.

Time frame: Within 12 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

Time frame: Within 24 months after randomization

Colorectal cancer incidence

Number of colorectal cancers detected during study period

Time frame: Within 24 months after randomization

Data from ClinicalTrials.gov

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