N/A N=5,127 Randomized Single-blind Screening

Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT05714644 ↗

Enrolled (actual)

5,127

Serious AEs

0.0%

Results posted

Dec 2025

Primary outcome: Primary: CRC Screening Completion Rates — 550; 751 Participants — p=0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FIT kit Screening Test (Other); Cologuard Screening Test (Other)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY CRC Screening Completion Rates	649; 854	<0.05 sig
SECONDARY CRC Screening Completion Rates	649; 854	<0.05 sig
SECONDARY Diagnostic Colonoscopy Completion Rates	13; 23	—

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.

Eligibility Criteria

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

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05714644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.