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

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

Study Overview

• Status: Completed
• Conditions: Colo-rectal Cancer
• Intervention / Treatment: Other: virtual technology

Detailed Description

Patients 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 Type: Interventional
• Enrollment (Actual): 960
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Jacksonville, Florida, United States, 32208
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Human (VH); Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements.	Other: virtual technology; 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 (ALEX)
Experimental: Text-Base (TB); Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements.	Other: virtual technology; 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 (ALEX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention to Screen for Colorectal Cancer (CRC)	Measure: Intention to Screen for Colorectal Cancer Item: I want to get screened for colorectal cancer. Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate a lower intention to get screened for colorectal cancer. Mean scores near 5 indicate a higher intention to get screened for colorectal cancer. Construct: Behavioral intention to screen No subscales	within the first 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Communication With a Provider About Colorectal Cancer (CRC)	Measure: Intention to talk to doctor about colorectal cancer screening. Construct: Behavioral intention to communicate Item: I will talk to my healthcare provider about colorectal cancer screening. Scale: 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores near 1 indicate a lower intention to talk to a healthcare professional about colorectal cancer screening. Mean scores near 5 indicate a high intention to talk to a healthcare professional about colorectal cancer screening. No subscales	Assessed after 24 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Benjamin Lok, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2018
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IRB201702765 -N; 1R01CA207689-01A1 (U.S. NIH Grant/Contract); OCR17004 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No