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

N/ANot Yet RecruitingNCT07781774

Washington University School of Medicine200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

200

Conditions

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

Interventions

Colorectal Cancer Education MaterialsBEHAVIORAL

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 kitDIAGNOSTIC_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 kitDIAGNOSTIC_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 CareBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)