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

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT03407417
Collaborator
National Cancer Institute (NCI) (NIH)
4,000
Enrollment
2
Locations
2
Arms
50.8
Anticipated Duration (Months)
2000
Patients Per Site
39.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: virtual technology - highly tailored
  • Other: virtual technology - tailored minimally
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
4000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Study Team will recruit an ethnically diverse sample of eligible patients (N = 3,000, 1,500 men, 1,500 women, evenly distributed across White, African-American, Hispanic/Latino) to complete the intervention
Primary Purpose:
Screening
Official Title:
A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care
Actual Study Start Date :
Nov 8, 2018
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fit Testing

Patients who self selected to receive FIT screening after interaction with the Application

Other: virtual technology - highly tailored
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.
Other Names:
  • Virtual human application

    		•
    Active Comparator: Non-FIT testing

    Patients who elected not to have FIT testing after interaction with the application

    Other: virtual technology - tailored minimally
    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.
    Other Names:
  • Standard tailored messaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 73 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

      1. with a negative result only
      1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32611
    2 University of Florida Jacksonville Florida United States 32208

    Sponsors and Collaborators

    • University of Florida
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Janice Kreiger, PhD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT03407417
    Other Study ID Numbers:
    • IRB201702765 -N
    • 1R01CA207689-01A1
    • OCR17004
    First Posted:
    Jan 23, 2018
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Mar 4, 2022