An interventional study of Colorectal Cancer Education Materials and Cologuard test kit in Colorectal Cancer (CRC) Screening, CRC Screening and Rectal Cancer, sponsored by Washington University School of Medicine. Not yet recruiting at 1 site in United States. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Screening
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.
Phase 1 Education Arm Inclusion Criteria:
Phase 1 Education Arm Exclusion Criteria:
Phase 2 (All Other Arms) Inclusion Criteria:
Phase 2 (All Other Arms) Exclusion Criteria:
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.
Behavioral: Colorectal Cancer Education Materials
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.
Diagnostic Test: Fecal immunochemical test kit
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.
Diagnostic Test: Cologuard test kit
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.
Behavioral: Usual Care
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.
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.
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 for patients eligible for colorectal cancer screening will be provided by the Barnes-Jewish Hospital Primary Care Medicine Clinic.
Change in CRC knowledge (Education Arm only)
Change in CRC knowledge will be measured by changes in the score of the Assessment of Colon Cancer Literacy (ACCL) test. The ACCL consists of 10-items with True/False/Unsure. The ACCL score ranges from 0 to 10 with a score of 7-10 indicating adequate literacy and scores of 0-6 indicating limited literacy.
Time frame: At enrollment and 3 months after educational intervention (total estimated time is 3 months)
Feasibility as measured by the percentage of kits returned (Mailed FIT and Mailed Cologuard Arms only)
Time frame: At 3 months after receiving kit (total estimated time 3 months)
Acceptability of stool based testing (Mailed FIT and Mailed Cologuard Arms only)
Acceptability will be assessed using the 3-item Customer Service Questionnaire (CSQ-3). The 3-items are rated on a 4-point Likert scale as follows: 1=Poor, 2=Fair, 3=Good, and 4=Excellent. Generally, the higher the score indicates greater customer satisfaction.
Time frame: At completion of testing or at 3 months after receiving test kit (total estimated time 3 months)
CRC screening completion rate (All arms)
CRC screening completion rate will be assessed through electronic health record (EHR) verification of screening completion.
Time frame: From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months)
Plan to share: No
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine