Clincosm LogoSign in Get a demo

CARES: Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05714644
Collaborator
Stand Up To Cancer (Other), University of California, Los Angeles (Other), Great Plains Tribal Leaders Health Board (Other)
8,000
Enrollment
2
Arms
18
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: FIT kit Screening Test
  • Other: Cologuard Screening Test
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The Health Centers are randomized to FIT testing or Cologuard.The Health Centers are randomized to FIT testing or Cologuard.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Mailed FIT Kit

A FIT kit mailed to the patient's home

Other: FIT kit Screening Test
FIT kit mailed to the patient's home
Active Comparator: Cologuard

A Cologuard test mailed to the patient's home

Other: Cologuard Screening Test
Cologuard test mailed to the patient's home

Outcome Measures

Primary Outcome Measures

  1. CRC Screening Completion Rates [3 months]

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

Secondary Outcome Measures

  1. CRC Screening Completion Rates [6 months]

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

  2. Diagnostic Colonoscopy Completion Rates [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jennifer Haas, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer S Haas, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05714644
Other Study ID Numbers:
  • 2022P001678
First Posted:
Feb 6, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of Feb 8, 2023