Back to resultsCommunity Collaboration to Advance Racial/Ethnic Equity in CRC Screening (CARES)
Primary Purpose
Colorectal Cancer
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FIT kit Screening Test
Cologuard Screening Test
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer
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: 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)
Sites / Locations
- UCLA
- Mass General Brigham
- Great Plains Tribal Leaders Health Board
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mailed FIT Kit
Cologuard
Arm Description
A FIT kit mailed to the patient's home
A Cologuard test mailed to the patient's home
Outcomes
Primary Outcome Measures
CRC Screening Completion Rates
completion rate of the stool-based screening test (Cologuard or FIT)
Secondary Outcome Measures
CRC Screening Completion Rates
completion rate of the stool-based screening test (Cologuard or FIT)
Diagnostic Colonoscopy Completion Rates
completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm)
Full Information
NCT ID
NCT05714644
First Posted
January 27, 2023
Last Updated
June 5, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Stand Up To Cancer, University of California, Los Angeles, Great Plains Tribal Leaders Health Board
1. Study Identification
Unique Protocol Identification Number
NCT05714644
Brief Title
Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
Acronym
CARES
Official Title
Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Stand Up To Cancer, University of California, Los Angeles, Great Plains Tribal Leaders Health Board
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The Health Centers are randomized to FIT testing or Cologuard.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mailed FIT Kit
Arm Type
Active Comparator
Arm Description
A FIT kit mailed to the patient's home
Arm Title
Cologuard
Arm Type
Active Comparator
Arm Description
A Cologuard test mailed to the patient's home
Intervention Type
Other
Intervention Name(s)
FIT kit Screening Test
Intervention Description
FIT kit mailed to the patient's home
Intervention Type
Other
Intervention Name(s)
Cologuard Screening Test
Intervention Description
Cologuard test mailed to the patient's home
Primary Outcome Measure Information:
Title
CRC Screening Completion Rates
Description
completion rate of the stool-based screening test (Cologuard or FIT)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
CRC Screening Completion Rates
Description
completion rate of the stool-based screening test (Cologuard or FIT)
Time Frame
6 months
Title
Diagnostic Colonoscopy Completion Rates
Description
completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Haas, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1772
Country
United States
Facility Name
Mass General Brigham
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Great Plains Tribal Leaders Health Board
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57703
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
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