FIT vs Cologuard Tests for Colorectal Cancer Screening
(CARES Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJennifer Haas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this pragmatic randomized clinical trial is to compare two colorectal (CRC) screening outreach approaches (FIT and Cologuard) in community health centers (CHC) in patients overdue for CRC screening. The main questions the project aims to answer are: What screening test has a higher completion rate? What screening test is more feasible and acceptable in a CHC setting? Patients will be sent a CRC screening test in the mail and will be asked to complete it at home and mail it back. Researchers will compare the completion rates for each screening test and will also look at the overall completion rate of both tests.

Eligibility Criteria

This trial is for people aged 45-75 who've visited a participating community clinic in the last two years, are alive, and speak English or Spanish. It's not for those with Ulcerative Colitis, Crohn's disease, existing colorectal cancer, or recent colorectal screening tests.

Inclusion Criteria

I prefer to communicate in English or Spanish.

Has had a visit at a participating community clinic within the last two years

Alive

+1 more

Exclusion Criteria

I have been diagnosed with Crohn's disease.

I have been diagnosed with colorectal cancer.

I have been diagnosed with Ulcerative Colitis.

+2 more

Participant Groups

The study compares two at-home CRC screening methods: FIT kit and Cologuard. Sent by mail to participants overdue for CRC screening at community health centers, researchers will see which test has higher completion rates and is more suitable for these settings.

2Treatment groups

Active Control

Group I: Mailed FIT KitActive Control1 Intervention

A FIT kit mailed to the patient's home

Group II: CologuardActive Control1 Intervention

A Cologuard test mailed to the patient's home