Colorectal Cancer
Conditions
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.
Interventions
OTHERFIT kit Screening Test
FIT kit mailed to the patient's home
OTHERCologuard Screening Test
Cologuard test mailed to the patient's home
Sponsors
Stand Up To Cancer
University of California, Los Angeles
Great Plains Tribal Leaders Health Board
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The Health Centers are randomized to FIT testing or Cologuard.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRC Screening Completion Rates | 3 months | completion rate of the stool-based screening test (FIT or Cologuard) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRC Screening Completion Rates | 6 months | completion rate of the stool-based screening test (Cologuard or FIT) |
| Diagnostic Colonoscopy Completion Rates | 6 months | completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm) |
Countries
United States
Participant flow
Recruitment details
Recruitment Dates: 6/7/23 through 10/24/23
Pre-assignment details
No enrolled patients were excluded from the study before assignment to arms.
Participants by arm
| Arm | Count |
|---|---|
| Mailed FIT Kit A FIT kit mailed to the patient's home | 2,435 |
| Cologuard A Cologuard test mailed to the patient's home | 2,692 |
| Total | 5,127 |
Baseline characteristics
| Characteristic | Mailed FIT Kit | Cologuard | Total |
|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 8.1 | 54.2 years STANDARD_DEVIATION 8.1 | 54.5 years STANDARD_DEVIATION 8.1 |
| Race/Ethnicity, Customized Hispanic | 1722 Participants | 2096 Participants | 3818 Participants |
| Race/Ethnicity, Customized Non-Hispanic, Black | 196 Participants | 173 Participants | 369 Participants |
| Race/Ethnicity, Customized Non-Hispanic, White | 456 Participants | 307 Participants | 763 Participants |
| Race/Ethnicity, Customized Other/Unknown | 61 Participants | 116 Participants | 177 Participants |
| Sex: Female, Male Female | 1437 Participants | 1581 Participants | 3018 Participants |
| Sex: Female, Male Male | 998 Participants | 1111 Participants | 2109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,435 | 0 / 2,692 |
| other Total, other adverse events | 0 / 2,435 | 0 / 2,692 |
| serious Total, serious adverse events | 0 / 2,435 | 0 / 2,692 |
Outcome results
Primary
CRC Screening Completion Rates
completion rate of the stool-based screening test (FIT or Cologuard)
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mailed FIT Kit | CRC Screening Completion Rates | 550 Participants |
| Cologuard | CRC Screening Completion Rates | 751 Participants |
p-value: 0.0595% CI: [0.8, 8.7]Regression, Logistic
Secondary
CRC Screening Completion Rates
completion rate of the stool-based screening test (Cologuard or FIT)
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mailed FIT Kit | CRC Screening Completion Rates | 649 Participants |
| Cologuard | CRC Screening Completion Rates | 854 Participants |
p-value: <0.0595% CI: [0.4, 8.5]Regression, Logistic
Secondary
Diagnostic Colonoscopy Completion Rates
completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm)
Time frame: 6 months
Population: The number is for participants who returned an abnormal stool test within 180 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mailed FIT Kit | Diagnostic Colonoscopy Completion Rates | 13 Participants |
| Cologuard | Diagnostic Colonoscopy Completion Rates | 23 Participants |