NCT07173985

Strategies for Optimizing a Mailed FIT Program in Appalachia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 45 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is examining strategies for optimizing mailed fecal immunochemical test (FIT) programs. In doing so, it will assess the efficacy of two promising strategies, FIT kit materials and patient navigation delivery mode. These strategies may help to improve colorectal cancer screening rates.

Detailed description

PRIMARY OBJECTIVES: 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

• Colonic Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	Standard FIT kit	Receive a standard FIT kit
BEHAVIORAL	Enhanced FIT kit	Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device
BEHAVIORAL	Telephone patient navigation	Receive telephone-based patient navigation
BEHAVIORAL	Text message patient navigation	Receive text message-based patient navigation

Timeline

• Start date: 2026-01-20
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2025-09-15
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States