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

Colo-rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03407417
• Other study ID #: IRB201702765 -N
• Secondary ID: 1R01CA207689-01A
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: January 31, 2024

Study information

• Verified date: October 2023
• Source: University of Florida
• Contact: Benjamin Lok
• Phone: (352) 214-9289
• Email: lok[@]cise.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colorectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	University of Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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