A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care

Study Overview
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Brief Summary
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The purpose of this proposal is to test the efficacy of a patient-centered, tailored message intervention delivered via virtual technology for increasing colorectal cancer (CRC) screening within guidelines among racial/ethnic minority and rural patients. This protocol focuses on the clinical portion of grant NCI 1RCA207689-01A1

Detailed Description
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Patients (N=3,000) will be recruited via a secure, clinical data warehouse to complete a patient-randomized test of the efficacy of the intervention for promoting initial and repeat FIT testing. Patients identified as eligible will be contacted through MyChart to test a web-based, culturally-sensitive virtual human intervention for CRC screening. The web-application will provide information to encourage CRC screening. Therefore, this study is a minimal risk study.

Official Title
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A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care

Conditions
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Colo-rectal Cancer

Intervention / Treatment
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* Other: virtual technology - highly tailored
* Other: virtual technology - tailored minimally


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to read English or Spanish at least at eighth-grade level have an email account or the ability to receive texts willingness to be re-contacted consent to MRR related to CRC screening not remember completing any CRC screening within recommended guidelines (i.e., <10 years for colonoscopy, <1 year for stool test). complete a FIT test: a) with a negative result only b) complete a FIT test with a positive result AND undergo a completion screening colonoscopy, Or c) complete a colonoscopy only. Exclusion Criteria: unable to read English at least at eighth-grade level doesn't have an email account or the ability to receive texts unwilling to be re-contacted Unable to consent to MRR related to CRC screening have not had <10 years for colonoscopy, or 1 year for stool test

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fit Testing<br>Patients who self selected to receive FIT screening after interaction with the Application | Other: virtual technology - highly tailored<br>* The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs.<br>* Other names: Virtual human application;|
| Active Comparator: Non-FIT testing<br>Patients who elected not to have FIT testing after interaction with the application | Other: virtual technology - tailored minimally<br>* The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Minimally tailored patient reminders will be customized using 4 randomly selected constructs.<br>* Other names: Standard tailored messaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of initial FIT screening | Fecal immunochemical test is a screening test for colon cancer. It tests for hidden blood in the stool, which can be an early sign of cancer. FIT only detects human blood from the lower intestines. | within the first 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of repeat Annual FIT screening | Fecal immunochemical test is a screening test for colon cancer. It tests for hidden blood in the stool, which can be an early sign of cancer. FIT only detects human blood from the lower intestines. | up to 24 months |