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

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ClinicalTrials.gov Identifier: NCT03407417
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Florida

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

Condition or disease Intervention/treatment Phase
Colo-rectal Cancer Other: virtual technology - highly tailored Other: virtual technology - tailored minimally Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Study Team will recruit an ethnically diverse sample of eligible patients (N = 3,000, 1,500 men, 1,500 women, evenly distributed across White, African-American, Hispanic/Latino) to complete the intervention
Primary Purpose: Screening
Official Title: A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fit Testing
Patients who self selected to receive FIT screening after interaction with the Application
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.
Other Name: Virtual human application

Active Comparator: Non-FIT testing
Patients who elected not to have FIT testing after interaction with the application
Other: 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.
Other Name: Standard tailored messaging




Primary Outcome Measures :
  1. Completion of initial FIT screening [ Time Frame: within the first 12 months ]
    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.


Secondary Outcome Measures :
  1. Completion of repeat Annual FIT screening [ Time Frame: up to 24 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • able to read English 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407417


Contacts
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Contact: Janice Krieger, PhD 3522730240 JANICEKRIEGER@UFL.EDU

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Janice Kreiger, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03407417     History of Changes
Other Study ID Numbers: IRB201702765 -N
1R01CA207689-01A1 ( U.S. NIH Grant/Contract )
OCR17004 ( Other Identifier: UF OnCore )
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases