This clinical trial evaluates whether a mailed fecal immunochemical test (FIT) kit improves colorectal cancer (CRC) screening in southern California community health centers (CHCs). FIT is a test to check for blood in the stool. A brush is used to collect water drops from around the surface of a stool while it is still in the toilet bowl. The samples are then sent to a laboratory, where they are checked for a human blood protein. Blood in the stool may be a sign of colorectal cancer. A mailed FIT kit is sent to the patients' address and includes instructions for the patient on the completion and return of the FIT. This may help doctors identify patients with blood in the stool and help to refer them for follow-up testing sooner. Using a mailed FIT kit may improve CRC screening in southern California CHCs.
Additional locations may be listed on ClinicalTrials.gov for NCT04941300.
Locations matching your search criteria
United States
California
La Jolla
UC San Diego Moores Cancer CenterStatus: Active
Contact: Elena Martinez
PRIMARY OBJECTIVE:
I. To conduct a 2-arm randomized trial to assess impact of a regionally-developed multilevel intervention for CRC screening, follow-up, and referral-to-care using a centralized approach by the Health Quality Partners of Southern California (HQP).
OUTLINE: Clinics are randomized to 1 of 2 arms and patients are assigned to the arm to which their clinic was randomized.
ARM I: Patients receive a mailed introductory letter (primer) describing importance of CRC screening and noting follow-up mail will include a FIT kit on study. Two weeks after the primer is mailed, patients receive a mailed FIT kit packet containing the FIT kit, an invitation inviting FIT completion, coronavirus 2019 (COVID-19) messaging for FIT completion due to the pandemic, FIT instructions, and a postage-paid envelope for return of the FIT kit on study. Patients who have not returned the FIT kit within 2 weeks of invitation receive reminder calls and text messages on study. Patients with abnormal FIT results receive patient navigator-based follow-up care coordination and referrals on study.
ARM II: Patients receive usual care CRC screening and follow-up care coordination on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUC San Diego Moores Cancer Center
Principal InvestigatorElena Martinez
