Recruiting

FIT Kit Materials & Patient Navigation

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07173985

Conditions

Colonic Neoplasms

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Standard FIT kit

Enhanced FIT kit

Telephone patient navigation

Text message patient navigation

Study Details

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.

Conditions

Colonic Neoplasms

Study ID

NCT07173985

Start date

Jan 20, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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:

\-

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Screening

Interventions and Outcome Measures

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)

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Paul Reiter, PhD

614-292-4803reiter.36@osu.edu

brownstone587@yahoo.com

Principal Investigator:

Paul Reiter

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-07-09.