Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening (CARES)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: FIT kit Screening Test; Other: Cologuard Screening Test

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.

• Study Type: Interventional
• Enrollment (Estimated): 5500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-1772
      • UCLA
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mass General Brigham
  • South Dakota
    • Rapid City, South Dakota, United States, 57703
      • Great Plains Tribal Leaders Health Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 45-75
2. Has had a visit at a participating community clinic within the last two years.
3. Alive
4. Patient's preferred language is English or Spanish

Exclusion Criteria:

Exclusion Criteria:

1. Has Ulcerative Colitis or Crohn's disease documented in the problem list. (Codes below).
2. Has colorectal cancer documented in the problem list. (Codes below).
3. Has had a FIT in the past 1 year
4. Has had a colonoscopy in the past 10 years

ICD-10 codes for exclusion criteria:

Ulcerative colitis:

• K51.0
• K51.2
• K51.3
• K51.4
• K51.5
• K51.8
• K51.9
• K52.8
• K52.9

Crohn's disease:

• K50.0
• K50.1
• K50.8
• K50.9

Colorectal cancer

• C18 (malignant neoplasm of colon)
• C18.0 (malignant neoplasm of cecum)
• C18.1 (malignant neoplasm of appendix)
• C18.2 (malignant neoplasm of ascending colon)
• C18.3 (malignant neoplasm of hepatic flexure)
• C18.4 (malignant neoplasm of transverse colon)
• C18.5 (malignant neoplasm of splenic flexure)
• C18.6 (malignant neoplasm of descending colon)
• C18.7 (malignant neoplasm of sigmoid colon)
• C18.8 (malignant neoplasm of overlapping sites of colon)
• C18.9 (malignant neoplasm of colon, unspecified)
• C19 (malignant neoplasm of rectosigmoid junction)
• C20 (malignant neoplasm of rectum)
• C21.8 (malignant neoplasm of overlapping sites of rectum, anus and anal canal)
• C26.0 (malignant neoplasm of intestinal tract, part unspecified)
• C78.5 (secondary malignant neoplasm of large intestine and rectum)
• C78.6 (secondary malignant neoplasm of retroperitoneum and peritoneum)
• D37.4 (neoplasm of uncertain behavior of colon)
• D37.5 (neoplasm of uncertain behavior of rectum)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mailed FIT Kit; A FIT kit mailed to the patient's home	Other: FIT kit Screening Test; FIT kit mailed to the patient's home
Active Comparator: Cologuard; A Cologuard test mailed to the patient's home	Other: Cologuard Screening Test; Cologuard test mailed to the patient's home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRC Screening Completion Rates	completion rate of the stool-based screening test (Cologuard or FIT)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRC Screening Completion Rates	completion rate of the stool-based screening test (Cologuard or FIT)	6 months
Diagnostic Colonoscopy Completion Rates	completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm)	6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: University of California, Los Angeles; Stand Up To Cancer; Great Plains Tribal Leaders Health Board
• Investigators: Principal Investigator: Jennifer Haas, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2022P001678

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No