Strategies for Optimizing a Mailed FIT Program in Appalachia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07173985

Enrollment

550

Registered

2025-09-15

Start date

2026-01-20

Completion date

2028-07-31

Last updated

2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms

Brief 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.

Interventions

BEHAVIORALStandard FIT kit

Receive a standard FIT kit

BEHAVIORALEnhanced FIT kit

Receive a enhanced FIT kit that includes a video brochure, disposable gloves, and a disposable stool collection device

BEHAVIORALTelephone patient navigation

Receive telephone-based patient navigation

BEHAVIORALText message patient navigation

Receive text message-based patient navigation

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

SCREENING

Masking

SINGLE (Subject)

Masking description

Participants are not aware of the research questions being tested in the trial.

Eligibility

Sex/Gender

ALL

Age

45 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Resident of an Appalachian county * 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

Design outcomes

Primary

Measure	Time frame	Description
FIT Return	Within 8 weeks of FIT kit distribution	Proportion of participants who return of a completed FIT kit

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPaul Reiter, PhD

Ohio State University Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026