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Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

NCT ID: NCT05714644

Last Updated: 2025-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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This is a 3-year pragmatic trial with four levels of intervention, including system-, provider-, patient-, and community-level components at each of the CARES clinical sites. Health system components will include the development and implementation of a CRC screening registry and tracking database to systematically and actively track patients overdue for screening, screening test completion, and abnormal screening results. Data systems will be coupled with process re-design to improve clinical workflow for screening outreach. Providers will receive educational support through a training session about the importance of CRC screening, screening test options, population management, and an instructional on how to complete a Cologuard kit (Cologuard arm only) or a FIT kit (FIT arm only). Patient components of the intervention vary by study arm. In sites randomized to Cologuard, patients will receive a mailed Cologuard kit and the Exact Sciences patient support program. Patients in clinics randomized to FIT will receive a mailed FIT kit with systematic reminders. Patients who test positive will be offered patient navigation to assist with completing a diagnostic colonoscopy.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The Health Centers are randomized to FIT testing or Cologuard.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mailed FIT Kit

A FIT kit mailed to the patient's home

Group Type ACTIVE_COMPARATOR

FIT kit Screening Test

Intervention Type OTHER

FIT kit mailed to the patient's home

Cologuard

A Cologuard test mailed to the patient's home

Group Type ACTIVE_COMPARATOR

Cologuard Screening Test

Intervention Type OTHER

Cologuard test mailed to the patient's home

Interventions

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FIT kit Screening Test

FIT kit mailed to the patient's home

Intervention Type OTHER

Cologuard Screening Test

Cologuard test mailed to the patient's home

Intervention Type OTHER

Eligibility Criteria

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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

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


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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stand Up To Cancer

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

Great Plains Tribal Leaders Health Board

UNKNOWN

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jennifer S Haas, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Haas, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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UCLA

Los Angeles, California, United States

Site Status

Mass General Brigham

Boston, Massachusetts, United States

Site Status

Great Plains Tribal Leaders Health Board

Rapid City, South Dakota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 39068985 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2022P001678

Identifier Type: -

Identifier Source: org_study_id