NCT05714644Completed
Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 5127 (actual)
- First submitted
- 27 Jan 2023
- Start date
- 7 Jun 2023
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05714644
What you commit to
- Study type: Interventional
- Participants enrolled: 5127
- From 7 Jun 2023 to the primary completion date, 30 Jun 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has Ulcerative Colitis or Crohn's disease documented in the problem list. (Codes below).
- Has colorectal cancer documented in the problem list. (Codes below).
- K52.9
- Crohn's disease:
- 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)
Other
- 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
- K50.0
- K50.1
- K50.8
- D37.4 (neoplasm of uncertain behavior of colon)
- D37.5 (neoplasm of uncertain behavior of rectum)
Who the study is looking for
- 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
Age in the registry: 45 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mass General Brigham Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Great Plains Tribal Leaders Health Board Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
Related publications
- Mailed Outreach for Colorectal Cancer Screening in Community Health Centers: The CARES Pragmatic Cluster Randomized Clinical Trial.JAMA Intern Med · 2026 · PMID 42043827
This page is information, not medical advice. Discuss any trial with your doctor.