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Clinical Trials/NCT03407417
NCT03407417CompletedNot Applicable

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

University of Florida3 sites in 1 country960 target enrollmentStarted: November 8, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
960
Locations
3
Primary Endpoint
Intention to Screen for Colorectal Cancer (CRC)

Study Overview

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Participant)

Masking Description

Study Team will recruit an ethnically diverse sample of eligible patients to complete the intervention.

Eligibility Criteria

Ages
45 Years to 73 Years (Adult, Older Adult)
Sex
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:
  • 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

Outcomes

Primary Outcomes

Intention to Screen for Colorectal Cancer (CRC)

Time Frame: within the first 12 months

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

Secondary Outcomes

  • Communication With a Provider About Colorectal Cancer (CRC)(Assessed after 24 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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