This clinical trial tests telephone and text patient navigation as well as an enhanced fecal immunochemical test (FIT) kit to increase colorectal cancer screening participation for people in Appalachia. FIT can be completed at home and sent/returned via mail, making mailed FIT programs a promising way to reach people and increase colorectal cancer screening. Such programs may be especially important for geographic regions with lower access to healthcare and lack of public transportation, such as the Appalachian region. Mailed FIT programs can be greatly improved upon by addressing common barriers to FIT return in order to increase overall participation. Telephone and text patient navigation as well as an enhanced FIT kit may increase colorectal cancer screening participation for people in Appalachia.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07173985.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Paul Reiter
Phone: 614-292-4803
PRIMARY OBJECTIVES:
I. Determine the efficacy of FIT kit materials and patient navigation (PN) delivery mode on increasing FIT return.
II. Determine if efficacy differs across key characteristics of participants and their communities (i.e., moderation).
III. Compare the cost-effectiveness of FIT kit materials and PN delivery mode on increasing FIT return.
OUTLINE: Patients are assigned to phase I or II.
PHASE I: Patients complete a focus group, over 1 hour, and a survey on study.
PHASE II: Patients are randomized to 1 of 4 groups.
GROUP 1: Patients receive access to telephone based patient navigation to assist with FIT completion and any follow-up steps that would be needed and receive a standard FIT kit consisting of a cover letter, a FIT test, instructions for the FIT test by the manufacturer, and a pre-addressed, postage-paid return envelope. Patients receive a repeat FIT kit 1 year after their original FIT kit was sent.
GROUP 2: Patients receive access to text message based patient navigation to assist with FIT completion and any follow-up steps that would be needed and receive a standard FIT kit consisting of a cover letter, a FIT test, instructions for the FIT test by the manufacturer, and a pre-addressed, postage-paid return envelope. Patients receive a repeat FIT kit 1 year after their original FIT kit was sent.
GROUP 3: Patients receive access to telephone based patient navigation to assist with FIT completion and any follow-up steps that would be needed and receive an enhanced FIT kit consisting of a cover letter, a FIT test, instructions for the FIT test by the manufacturer, a pre-addressed, postage-paid return envelope, a video brochure about the FIT test, disposable gloves to assist with specimen collection, and a disposable stool collection device. Patients receive a repeat FIT kit 1 year after their original FIT kit was sent.
GROUP 4: Patients receive access to text message based patient navigation to assist with FIT completion and any follow-up steps that would be needed and receive an enhanced FIT kit consisting of a cover letter, a FIT test, instructions for the FIT test by the manufacturer, a pre-addressed, postage-paid return envelope, a video brochure about the FIT test, disposable gloves to assist with specimen collection, and a disposable stool collection device. Patients receive a repeat FIT kit 1 year after their original FIT kit was sent.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorPaul Reiter
