NCT05714644

Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,127 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a 3-year pragmatic trial with four levels of intervention, including system-, provider-, patient-, and community-level components at each of the CARES clinical sites. Health system components will include the development and implementation of a CRC screening registry and tracking database to systematically and actively track patients overdue for screening, screening test completion, and abnormal screening results. Data systems will be coupled with process re-design to improve clinical workflow for screening outreach. Providers will receive educational support through a training session about the importance of CRC screening, screening test options, population management, and an instructional on how to complete a Cologuard kit (Cologuard arm only) or a FIT kit (FIT arm only). Patient components of the intervention vary by study arm. In sites randomized to Cologuard, patients will receive a mailed Cologuard kit and the Exact Sciences patient support program. Patients in clinics randomized to FIT will receive a mailed FIT kit with systematic reminders. Patients who test positive will be offered patient navigation to assist with completing a diagnostic colonoscopy.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	FIT kit Screening Test	FIT kit mailed to the patient's home
OTHER	Cologuard Screening Test	Cologuard test mailed to the patient's home

Timeline

• Start date: 2023-06-07
• Primary completion: 2024-06-30
• Completion: 2025-09-30
• First posted: 2023-02-06
• Last updated: 2025-12-26
• Results posted: 2025-12-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study