Education and Testing for Colorectal Cancer Screening
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Cassandra Fritz, MD, MPHS
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults aged 45-75 who are patients at a primary care clinic, have health insurance, and need colorectal cancer screening. People with a history of colorectal cancer or inflammatory bowel disease cannot join. One group also includes those from a previous related study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Educational Intervention
Participants complete the Assessment of Colon Cancer Literacy (ACCL) as a pre-test and receive education materials. Three months later, they repeat ACCL testing.
Mailed Testing Outreach
Participants receive mailed FIT or Cologuard tests with instructions and return envelopes. They are contacted three times by phone as reminders to complete the kit.
Follow-up
Participants are monitored for CRC screening completion through electronic health record verification.
What Are the Treatments Tested in This Trial?
Interventions
- Cologuard test kit
- Colorectal Cancer Education Materials
- Fecal immunochemical test kit
Trial Overview
The study compares different ways to encourage colorectal cancer screening: sending educational materials, mailing stool test kits (FIT or Cologuard), or providing usual care. Participants are assigned by their clinic team to one of these groups.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
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