Protocol Summary

Protocol No.: OCR17004

Sponsor Protocol No.: R01 - CA2017689-02; UF-CPS-002; IRB201702765

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

Principal Investigator: Raup-Krieger, Janice

Objective: 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

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.

Phase: Phase III

Age Group: Adult

Age: 50 Years - 73 Years

Gender: All

Scope: Local

Treatment:

Experimental: Fit Testing
Patients who self selected to receive FIT screening after interaction with the Application

Active Comparator: Non-FIT testing
Patients who elected not to have FIT testing after interaction with the application

Detailed Eligibility:

Inclusion Criteria: - able to read English 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

Applicable Conditions:

  • Colon Cancer
  • Participation Institution:

  • UF Gainesville
  • UF Jacksonville
  • More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03407417