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OpenTrials
Completed

NCT Number: NCT05714644

Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria

  • Has Ulcerative Colitis or Crohn's disease documented in the problem list. (Codes below).
  • Has colorectal cancer documented in the problem list. (Codes below).
  • Has had a FIT in the past 1 year
  • 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)

Treatment and study plan

FIT kit Screening Test

Other

FIT kit mailed to the patient's home

Cologuard Screening Test

Other

Cologuard test mailed to the patient's home

Primary outcomes

  1. CRC Screening Completion Rates

    Time frame: 3 months

    completion rate of the stool-based screening test (FIT or Cologuard)

Secondary outcomes

  1. CRC Screening Completion Rates

    Time frame: 6 months

    completion rate of the stool-based screening test (Cologuard or FIT)

  2. Diagnostic Colonoscopy Completion Rates

    Time frame: 6 months

    completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Great Plains Tribal Leaders Health Board
  • Stand Up To Cancer
  • University of California, Los Angeles

Registry information

Acronym: CARES

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 6, 2023
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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