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Completed

NCT Number: NCT03407417

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

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

45 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Virtual human application (ALEX)

Primary outcomes

  1. 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

  1. Communication With a Provider About Colorectal Cancer (CRC)

    Time frame: Assessed after 24 months

    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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2018
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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