Strategies for Optimizing a Mailed FIT Program in Appalachia

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT07173985
Status
Recruiting
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Conditions

  • Colonic Neoplasms

Eligibility Criteria

Sex
ALL
Age
45 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 20, 2026
Status verified
Jan 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING

Arms

  • Experimental: Group A (standard FIT kit plus telephone PN)
    Participants receive standard FIT kit plus telephone patient navigation (PN)
  • Experimental: Group B (standard FIT kit plus text message PN)
    Participants receive standard FIT kit plus text message patient navigation (PN)
  • Experimental: Group C (enhanced FIT kit plus telephone PN)
    Participants receive enhanced FIT kit plus telephone patient navigation (PN)
  • Experimental: Group D (enhanced FIT kit plus text message PN)
    Participants receive enhanced FIT kit plus text message patient navigation (PN)

Primary Outcome Measure

FIT Return [ Time Frame: Within 8 weeks of FIT kit distribution ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Paul Reiter, PhD
[email protected]
614-292-4803
[email protected]
Paul Reiter (PRINCIPAL_INVESTIGATOR)

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