Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

NCT05714644 | Completed Results FDA Device

• 1 other identifier: 2022P001678
• Study Type: interventional
• Target: 5,127
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• CRC Screening Completion Rates

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

  3 months

Secondary Outcomes (2)

• CRC Screening Completion Rates

  6 months

• Diagnostic Colonoscopy Completion Rates

  6 months

Study Arms (2)

Mailed FIT Kit

ACTIVE COMPARATOR

A FIT kit mailed to the patient's home

Other: FIT kit Screening Test

Cologuard

ACTIVE COMPARATOR

A Cologuard test mailed to the patient's home

Other: Cologuard Screening Test

Interventions

FIT kit Screening Test OTHER

FIT kit mailed to the patient's home

Mailed FIT Kit

Cologuard Screening Test OTHER

Cologuard test mailed to the patient's home

Cologuard

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Ulcerative colitis:
• K51.0
• K51.2
• K51.3
• K51.4
• K51.5
• K51.8
• K51.9
• K52.8
• K52.9
• Crohn's disease:

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Stand Up To Cancer: collaborator
• University of California, Los Angeles: collaborator
• Great Plains Tribal Leaders Health Board: collaborator

Study Sites (3)

UCLA

Los Angeles, California, 90095-1772, United States

Location

Mass General Brigham

Boston, Massachusetts, 02114, United States

Location

Great Plains Tribal Leaders Health Board

Rapid City, South Dakota, 57703, United States

Location

Related Publications (1)

• May 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 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

Boston and LA used different FIT kit brands. No access to patient-level data about outreach attempts or contacts from the Exact Science patient support program because this information is proprietary. Unable to comment on cost-effectiveness. Unable to randomize the South Dakota site because unable to identify another CHC in the region to participate.

Results Point of Contact

• Title: Jennifer Haas, MD
• Organization: Massachusetts General Hospital

jennifer.haas@mgh.harvard.edu

6176434266

Study Officials

• Jennifer Haas, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The Health Centers are randomized to FIT testing or Cologuard.

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: June 7, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2025
• Last Updated: December 26, 2025
• Results First Posted: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)