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

NCT07781774 | Not Yet Recruiting FDA Device

• 1 other identifier: 202606027
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer (CRC) Screening; CRC Screening; Rectal Cancer; Colon Cancer; Colorectal Cancer

Keywords

Colorectal cancer; Screening; Primary care; Teaching clinics

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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.

  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.

  From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months)

Study Arms (4)

Education

EXPERIMENTAL

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

Mailed FIT

EXPERIMENTAL

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

Mailed Cologuard

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

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.

Education

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.

Mailed Cologuard

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.

Mailed FIT

Usual Care BEHAVIORAL

Usual care for patients eligible for colorectal cancer screening will be provided by the Barnes-Jewish Hospital Primary Care Medicine Clinic.

Usual Care

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously enrolled in prior study IRB #202202059 who agreed to participate in future research

You may not qualify if:

• Not enrolled in prior study IRB #202202059
• Primary Care Medicine Clinic patient (PRMC)
• Eligible for CRC screening
• Between age 45-75 years old
• Have eligible health insurance
• Prior history of colorectal cancer
• Diagnosis of inflammatory bowel disease

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Cassandra Fritz, MD, MPHS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Fritz, MD, MPHS

CONTACT

314-454-8165; cfritz@wustl.edu

Darren Nix

CONTACT

314-362-3201; nixd@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients are assigned to a resident primary care provider. Each resident is assigned to a team-based structure within the resident clinic, and there are 12 resident teams. Each team is composed of 12 residents, and each resident has a patient panel of \~100 patients. Participants will be recruited via resident patient panels and randomized 1:1:1 by resident clinic teams. The Education Arm will be drawn from patients who agreed to be recontacted from a prior study and will not be randomized.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)