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NCT Number: NCT07781774

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

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.

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Key information

Conditions

Colorectal Cancer (CRC) Screening CRC Screening Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Phase 1 Education Arm Inclusion Criteria:

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

Phase 1 Education Arm Exclusion Criteria:

  • Not enrolled in prior study IRB #202202059

Phase 2 (All Other Arms) Inclusion Criteria:

  • Primary Care Medicine Clinic patient (PRMC)
  • Eligible for CRC screening
  • Between age 45-75 years old
  • Have eligible health insurance

Phase 2 (All Other Arms) Exclusion Criteria:

  • Prior history of colorectal cancer
  • Diagnosis of inflammatory bowel disease

Treatment and study plan

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.

Primary outcomes

  1. Change in CRC knowledge (Education Arm only)

    Time frame: At enrollment and 3 months after educational intervention (total estimated time is 3 months)

    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.

  2. 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)

  3. Acceptability of stool based testing (Mailed FIT and Mailed Cologuard Arms only)

    Time frame: At completion of testing or at 3 months after receiving test kit (total estimated time 3 months)

    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.

  4. CRC screening completion rate (All arms)

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

    CRC screening completion rate will be assessed through electronic health record (EHR) verification of screening completion.

Study contacts

Contact information is provided by the study sponsor or research team.

Cassandra Fritz, MD, MPHS

CONTACT

[email protected]

314-454-8165

Darren Nix

CONTACT

[email protected]

314-362-3201

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Improving Colorectal Cancer Screening Uptake Through Patient-Centered Education and Mailed Stool-Based Testing Outreach in the Primary Care Medicine Clinic

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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