Strategies for Optimizing a Mailed FIT Program in Appalachia

The Ohio State University

Status: Enrolling

Conditions: Colonic Neoplasms

Treatments: Behavioral: Standard FIT kit; Behavioral: Text message patient navigation; Behavioral: Telephone patient navigation; Behavioral: Enhanced FIT kit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07173985

OSU-24377

R01CA282162 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 45 to 74 years old

Volunteers: No 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

-

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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500 participants in 4 patient groups

Group A (standard FIT kit plus telephone PN)

Experimental group

Description:

Participants receive standard FIT kit plus telephone patient navigation (PN)

Treatment:

Behavioral: Telephone patient navigation

Behavioral: Standard FIT kit

Group B (standard FIT kit plus text message PN)

Experimental group

Description:

Participants receive standard FIT kit plus text message patient navigation (PN)

Treatment:

Behavioral: Text message patient navigation

Behavioral: Standard FIT kit

Group C (enhanced FIT kit plus telephone PN)

Experimental group

Description:

Participants receive enhanced FIT kit plus telephone patient navigation (PN)

Treatment:

Behavioral: Enhanced FIT kit

Behavioral: Telephone patient navigation

Group D (enhanced FIT kit plus text message PN)

Experimental group

Description:

Participants receive enhanced FIT kit plus text message patient navigation (PN)

Treatment:

Behavioral: Enhanced FIT kit

Behavioral: Text message patient navigation