Clinical trial NCT05714644: Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
Official title: Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Stand Up To Cancer
name: University of California, Los Angeles
name: Great Plains Tribal Leaders Health Board
First posted: 2023-02-06
Enrollment: 5255
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Health Centers are randomized to FIT testing or Cologuard.
Primary purpose: SCREENING

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.

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)

Primary outcomes:
measure: CRC Screening Completion Rates
timeFrame: 3 months
Secondary outcomes:
measure: CRC Screening Completion Rates
timeFrame: 6 months
measure: Diagnostic Colonoscopy Completion Rates
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
city: Rapid City
country: United States
facility: Great Plains Tribal Leaders Health Board
state: South Dakota
Study officials:
affiliation: Massachusetts General Hospital
name: Jennifer Haas, MD
role: PRINCIPAL_INVESTIGATOR
References: