This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. FITs are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of CRC screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. For FIT-based CRC screening to be effective, abnormal results must be followed by a colonoscopy, however, many patients fail to complete this recommended follow-up test. The multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a CRC screening patient navigator, an educational video, and transportation assistance. The navigator provides patient support and assistance with colonoscopy scheduling. The educational video addresses identified patient fears around colonoscopies. Transportation assistance is offered after the colonoscopy through a rideshare program, to address transportation barriers. Therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal FIT results.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06822530.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Rachel B. Issaka
Phone: 206-667-1447
PRIMARY OBJECTIVE:
I. Assess the effectiveness of a multilevel intervention on follow-up colonoscopy completion.
SECONDARY OBJECTIVES:
I. Assess the effectiveness of a multilevel intervention on follow-up colonoscopy completion.
II. Evaluate the facilitators and barriers to the reach, acceptability, fidelity and implementation of the multilevel intervention.
III. Evaluate the cost of implementing the multilevel intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling on study.
GROUP II: Patients receive usual care as described in Group I and additionally receive a quick response (QR) code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or electronic health record (EHR) platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse on study.
After completion of study intervention, patients are followed up for 18 months.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorRachel B. Issaka