Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

Colorectal Cancer Clinical Trial

— CARES  

Official title:

Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05714644
• Other study ID #: 2022P001678
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5500
• Est. completion date: June 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• FIT kit Screening Test
FIT kit mailed to the patient's home
• Cologuard Screening Test
Cologuard test mailed to the patient's home

Locations

Country	Name	City	State
United States	Mass General Brigham	Boston	Massachusetts
United States	UCLA	Los Angeles	California
United States	Great Plains Tribal Leaders Health Board	Rapid City	South Dakota

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Great Plains Tribal Leaders Health Board, Stand Up To Cancer, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRC Screening Completion Rates	completion rate of the stool-based screening test (Cologuard or FIT)	3 months
Secondary	CRC Screening Completion Rates	completion rate of the stool-based screening test (Cologuard or FIT)	6 months
Secondary	Diagnostic Colonoscopy Completion Rates	completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm)	6 months