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Trial Title:
Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
NCT ID:
NCT05714644
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The Health Centers are randomized to FIT testing or Cologuard.
Primary purpose:
Screening
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
FIT kit Screening Test
Description:
FIT kit mailed to the patient's home
Arm group label:
Mailed FIT Kit
Intervention type:
Other
Intervention name:
Cologuard Screening Test
Description:
Cologuard test mailed to the patient's home
Arm group label:
Cologuard
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
45 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
UCLA
Address:
City:
Los Angeles
Zip:
90095-1772
Country:
United States
Facility:
Name:
Mass General Brigham
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
Great Plains Tribal Leaders Health Board
Address:
City:
Rapid City
Zip:
57703
Country:
United States
Start date:
May 31, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
Stand Up To Cancer
Agency class:
Other
Collaborator:
Agency:
University of California, Los Angeles
Agency class:
Other
Collaborator:
Agency:
Great Plains Tribal Leaders Health Board
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05714644