Strategies for Optimizing a Mailed FIT Program in Appalachia
NCT ID: NCT07173985
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2026-01-20
2028-07-31
Brief Summary
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Detailed Description
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Determine the efficacy of two strategies for increasing colorectal cancer screening.
OUTLINE: Participants are randomized to 1 of 4 groups.
GROUP I: Participants receive a standard FIT kit plus telephone patient navigation.
GROUP II: Participants receive a standard FIT kit plus text message patient navigation.
GROUP III: Participants receive an enhanced FIT kit plus telephone patient navigation.
GROUP IV: Participants receive an enhanced FIT kit plus text message patient navigation.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SCREENING
SINGLE
Study Groups
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Group A (standard FIT kit plus telephone PN)
Participants receive standard FIT kit plus telephone patient navigation (PN)
Standard FIT kit
Receive a standard FIT kit
Telephone patient navigation
Receive telephone-based patient navigation
Group B (standard FIT kit plus text message PN)
Participants receive standard FIT kit plus text message patient navigation (PN)
Standard FIT kit
Receive a standard FIT kit
Text message patient navigation
Receive text message-based patient navigation
Group C (enhanced FIT kit plus telephone PN)
Participants receive enhanced FIT kit plus telephone patient navigation (PN)
Enhanced FIT kit
Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device
Telephone patient navigation
Receive telephone-based patient navigation
Group D (enhanced FIT kit plus text message PN)
Participants receive enhanced FIT kit plus text message patient navigation (PN)
Enhanced FIT kit
Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device
Text message patient navigation
Receive text message-based patient navigation
Interventions
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Standard FIT kit
Receive a standard FIT kit
Enhanced FIT kit
Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device
Telephone patient navigation
Receive telephone-based patient navigation
Text message patient navigation
Receive text message-based patient navigation
Eligibility Criteria
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Inclusion Criteria
* Medical visit at a participating health system in the past two years
* Average-risk for colorectal cancer
* Not currently within colorectal cancer screening guidelines
Exclusion Criteria
45 Years
74 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Paul Reiter
Principal Investigator
Principal Investigators
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Paul Reiter, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Facility Contacts
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Role: backup
Related Links
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The Jamesline
Other Identifiers
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OSU-24377
Identifier Type: -
Identifier Source: org_study_id
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