Clinical trial · Interventional
Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cologuard Screening Test | Other | — | UNRESOLVED |
| FIT kit Screening Test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mailed FIT Kit
- description
- A FIT kit mailed to the patient's home
- interventionNames
- Other: FIT kit Screening Test
- type
- ACTIVE_COMPARATOR
- label
- Cologuard
- description
- A Cologuard test mailed to the patient's home
- interventionNames
- Other: Cologuard Screening Test
Primary outcomes (1)
- measure
- CRC Screening Completion Rates
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (2)
- BACKGROUNDMay FP, Brodney S, Tuan JJ, Syngal S, Chan AT, Glenn B, Johnson G, Chang Y, Drew DA, Moy B, Rodriguez NJ, Warner ET, Anyane-Yeboa A, Ukaegbu C, Davis AQ, Schoolcraft K, Regan S, Yoguez N, Kuney S, Le Beaux K, Jeffries C, Lee ET, Bhat R, Haas JS. Community Collaboration to Advance Racial/Ethnic Equity in Colorectal Cancer Screening: Protocol for a Multilevel Intervention to Improve Screening and Follow-up in Community Health Centers. Contemp Clin Trials. 2024 Oct;145:107639. doi: 10.1016/j.cct.2024.107639. Epub 2024 Jul 26. PMID 39068985
- DERIVEDMay FP, Brodney S, Tuan JJ, Syngal S, Chan AT, Glenn B, Johnson G, Chang Y, Drew DA, Moy B, Rodriguez NJ, Warner ET, Anyane-Yeboa A, Ukaegbu C, Davis AQ, Schoolcraft K, Regan S, Le Beaux K, Lee ET, Bhat R, Gordon A, Phan LK, Chirino AFC, Marotta CJ, Kindermann RGZ, Haas JS. Mailed Outreach for Colorectal Cancer Screening in Community Health Centers: The CARES Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 1;186(6):703-712. doi: 10.1001/jamainternmed.2026.1170. PMID 42043827