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

NCT03407417 | Completed Results DMC

• 3 other identifiers: IRB201702765 -N1R01CA207689-01A1OCR17004
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 2

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

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Communication With a Provider About Colorectal Cancer (CRC)

  Assessed after 24 months

Study Arms (2)

Virtual Human (VH)

EXPERIMENTAL

Patients were randomly assigned to a virtual human (VH) screening condition after completing the eligibility for CRC requirements.

Other: virtual technology

Text-Base (TB)

EXPERIMENTAL

Patients were randomly assigned to a text-based (TB) screening condition after completing the eligibility for CRC requirements.

Other: virtual technology

Interventions

virtual technology OTHER

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.

Also known as: Virtual human application (ALEX)

Text-Base (TB); Virtual Human (VH)

Eligibility Criteria

• Age: 45 Years - 73 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Florida

Jacksonville, Florida, 32208, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Dr. Benjamin Lok
• Organization: University of Florida

lok@ufl.edu

352-214-9829

Study Officials

• Benjamin Lok

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study Team will recruit an ethnically diverse sample of eligible patients to complete the intervention.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 23, 2018
• Study Start: November 8, 2018
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)