Back to resultsA Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care
Primary Purpose
Colo-rectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
virtual technology - highly tailored
virtual technology - tailored minimally
Sponsored by
About this trial
This is an interventional screening trial for Colo-rectal Cancer
Eligibility Criteria
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
Sites / Locations
- University of FloridaRecruiting
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fit Testing
Non-FIT testing
Arm Description
Patients who self selected to receive FIT screening after interaction with the Application
Patients who elected not to have FIT testing after interaction with the application
Outcomes
Primary Outcome Measures
Completion of initial FIT screening
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
Completion of repeat Annual FIT screening
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.
Full Information
NCT ID
NCT03407417
First Posted
January 15, 2018
Last Updated
October 11, 2023
Sponsor
University of Florida
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03407417
Brief Title
A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care
Official Title
A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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
Allocation
Randomized
Enrollment
4000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fit Testing
Arm Type
Experimental
Arm Description
Patients who self selected to receive FIT screening after interaction with the Application
Arm Title
Non-FIT testing
Arm Type
Active Comparator
Arm Description
Patients who elected not to have FIT testing after interaction with the application
Intervention Type
Other
Intervention Name(s)
virtual technology - highly tailored
Other Intervention Name(s)
Virtual human application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
virtual technology - tailored minimally
Other Intervention Name(s)
Standard tailored messaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion of initial FIT screening
Description
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.
Time Frame
within the first 12 months
Secondary Outcome Measure Information:
Title
Completion of repeat Annual FIT screening
Description
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.
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Lok
Phone
(352) 214-9289
Email
lok@cise.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Lok
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32208
Country
United States
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Patient-centered Intervention Using Technology to Reduce Colorectal Cancer Disparities in Primary Care
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