Improving Colorectal Cancer Screening Uptake Through Education and Stool-Based Testing Outreach

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07781774
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Colorectal Cancer Education Materials — BEHAVIORAL
    Education materials are compiled from the American College of Gastroenterology (ACG) and the City of Hope. The education materials are at a 6th grade reading level. Materials detail digestive system and polyp background, colorectal cancer (CRC) risk factors, warning signs, screening options, recommended initial screening age, and stool-based screening and colonoscopy processes.
  • Cologuard test kit — DIAGNOSTIC_TEST
    The Cologuard test will be mailed to the participants. Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.
  • Fecal immunochemical test kit — DIAGNOSTIC_TEST
    The Fecal immunochemical test (FIT) will be mailed to the participants. Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.
  • Usual Care — BEHAVIORAL
    Usual care for patients eligible for colorectal cancer screening will be provided by the Barnes-Jewish Hospital Primary Care Medicine Clinic.

Study Details

This is a mixed-methods implementation pilot combining an educational intervention with a mailed stool-based testing outreach feasibility study within a resident primary care clinic. Participants will be assigned by clinic team to education, mailed FIT, mailed Cologuard, or usual care comparison groups.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Education
    Participants will complete the Assessment of Colon Cancer Literacy (ACCL) as a pre-test prior to receiving education materials. After the pre-test, participants will be provided with ACCL education materials. Three months after being provided education materials, participants will repeat ACCL testing.
  • Experimental: Mailed FIT
    Participants will receive a mailed package including 1 FIT test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart. Participants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient.
  • Experimental: Mailed Cologuard
    Participants will receive a mailed package including 1 Cologuard test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants will have 3 months to return the kit. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart. Participants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient.
  • Active Comparator: Usual Care
    Participants will receive usual care from provider after enrollment with no intervention. Usual care includes providers offering standard screening options including FIT, Cologuard, and colonoscopy at the initial visit with no default option or structured follow-up.

Primary Outcome Measure

Change in CRC knowledge (Education Arm only) [ Time Frame: At enrollment and 3 months after educational intervention (total estimated time is 3 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Cassandra Fritz, MD, MPHS
[email protected]
314-454-8165
Darren Nix
[email protected]
314-362-3201
Kamilah Scales, MD (SUB_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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