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

Not Applicable

Completed

• Conditions: Colo-rectal Cancer
• Interventions: Other: virtual technology - tailored minimally; Other: virtual technology - highly tailored

• Registration Number: NCT03407417
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-15
• Study First Posted: 2018-01-23
• Study Start: 2018-11-08
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3300

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-FIT testing	virtual technology - tailored minimally	Patients who elected not to have FIT testing after interaction with the application
Fit Testing	virtual technology - highly tailored	Patients who self selected to receive FIT screening after interaction with the Application

Primary Outcome Measures

Name	Time	Method
Completion of initial FIT screening	within the first 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Completion of repeat Annual FIT screening	up to 24 months	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Jacksonville, Florida, United States