An interventional study of FIT kit Screening Test and Cologuard Screening Test in Colorectal Cancer, sponsored by Massachusetts General Hospital. Completed at 3 sites in United States. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Screening
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's enrollment of 5,127 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
ICD-10 codes for exclusion criteria:
Ulcerative colitis:
Crohn's disease:
Colorectal cancer
A FIT kit mailed to the patient's home
Other: FIT kit Screening Test
A Cologuard test mailed to the patient's home
Other: Cologuard Screening Test
FIT kit mailed to the patient's home
Cologuard test mailed to the patient's home
CRC Screening Completion Rates
completion rate of the stool-based screening test (FIT or Cologuard)
Time frame: 3 months
CRC Screening Completion Rates
completion rate of the stool-based screening test (Cologuard or FIT)
Time frame: 6 months
Diagnostic Colonoscopy Completion Rates
completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm)
Time frame: 6 months
Recruitment Dates: 6/7/23 through 10/24/23
| Milestone | Mailed FIT Kit | Cologuard |
|---|---|---|
| Started | 2435 | 2692 |
| Completed | 2435 | 2692 |
| Not completed | 0 | 0 |
completion rate of the stool-based screening test (FIT or Cologuard)
| Participants | Mailed FIT Kit | Cologuard |
|---|---|---|
| CRC Screening Completion Rates | 550 | 751 |
completion rate of the stool-based screening test (Cologuard or FIT)
| Participants | Mailed FIT Kit | Cologuard |
|---|---|---|
| CRC Screening Completion Rates | 649 | 854 |
completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm)
| Participants | Mailed FIT Kit | Cologuard |
|---|---|---|
| Diagnostic Colonoscopy Completion Rates | 13 | 23 |
Collected over From enrollment through 180 days for negative test result or an additional 180 days after a positive FIT or Cologuard was returned, up to 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mailed FIT Kit | 0/2,435 (0%) | 0/2,435 (0%) | 0/2,435 (0%) |
| Cologuard | 0/2,692 (0%) | 0/2,692 (0%) | 0/2,692 (0%) |
| Age, Continuous(years) | Mailed FIT Kit | Cologuard | Total |
|---|---|---|---|
| Mean | 54.9 ± 8.1 | 54.2 ± 8.1 | 54.5 ± 8.1 |
| Race/Ethnicity, Customized(Participants) | Mailed FIT Kit | Cologuard | Total |
|---|---|---|---|
| Non-Hispanic, White | 456 | 307 | 763 |
| Non-Hispanic, Black | 196 | 173 | 369 |
| Hispanic | 1722 | 2096 | 3818 |
| Other/Unknown | 61 | 116 | 177 |
| Sex: Female, Male(Participants) | Mailed FIT Kit | Cologuard | Total |
|---|---|---|---|
| Female | 1437 | 1581 | 3018 |
| Male | 998 | 1111 | 2109 |
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Plan to share: No
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital