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.
Previously enrolled in prior study IRB #202202059 who agreed to participate in future research
Not enrolled in prior study IRB #202202059
Primary Care Medicine Clinic patient (PRMC)
Eligible for CRC screening
Between age 45-75 years old
Parallel
Colorectal Cancer Education Materials
BehavioralEducation 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 testThe 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 testThe 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
BehavioralUsual 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.
Feasibility as measured by the percentage of kits returned (Mailed FIT and Mailed Cologuard Arms only)
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.
CRC screening completion rate (All arms)
CRC screening completion rate will be assessed through electronic health record (EHR) verification of screening completion.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
