NCT05714644: CARES

Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

Completed NA Results posted Last updated 26 December 2025

What this trial tests

NA trial testing FIT kit Screening Test in Colorectal Cancer in 5,127 participants. Completed in 30 September 2025.

Timeline

7 June 2023

Primary endpoint
30 June 2024

30 September 2025

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	screening
Enrollment	5,127
Start date	7 June 2023
Primary completion	30 June 2024
Estimated completion	30 September 2025
Sites	3 locations across United States

Drugs / interventions tested

• FIT kit Screening Test
• Cologuard Screening Test

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Massachusetts General Hospital

Who can join

Adults 45 to 75, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CRC Screening Completion Rates Primary · 3 months

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

Group	Value	95% CI
Mailed FIT Kit	550
Cologuard	751

CRC Screening Completion Rates Secondary · 6 months

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

Group	Value	95% CI
Mailed FIT Kit	649
Cologuard	854

Diagnostic Colonoscopy Completion Rates Secondary · 6 months

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

Group	Value	95% CI
Mailed FIT Kit	13
Cologuard	23

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Progress in Clinical Research in Secondary Prevention and Early Detection of Colorectal Cancer.
   Partyka O, Pajewska M, Czerw A, Deptała A, et al · · 2025 · cited 2× · PMID 39941735 · DOI 10.3390/cancers17030367
2. 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.
   May FP, Brodney S, Tuan JJ, Syngal S, et al · · 2024 · cited 2× · PMID 39068985 · DOI 10.1016/j.cct.2024.107639
3. Mailed Outreach for Colorectal Cancer Screening in Community Health Centers: The CARES Pragmatic Cluster Randomized Clinical Trial.
   May FP, Brodney S, Tuan JJ, Syngal S, et al · · 2026 · PMID 42043827 · DOI 10.1001/jamainternmed.2026.1170
4. Strategies to build trustworthiness and increase diversity in colorectal cancer biospecimen research: a multi-phase, multi-site qualitative study.
   Roybal KL, Nava-Coulter B, Roberts J, Harden D, et al · · 2026 · PMID 41483113 · DOI 10.1007/s12687-025-00855-7