This clinical trial compares an educational video intervention versus usual care of no video intervention in decreasing patient fear of a colonoscopy procedure after receiving a positive fecal immunochemical test (FIT). The lack of a follow-up colonoscopy after an abnormal FIT result is associated with an increased risk of colorectal cancer mortality, advanced-stage colorectal cancer, among other complications, compared to the completion of a follow-up colonoscopy. An educational video may reduce patient fear and increase knowledge, self-efficacy, and intent to complete a colonoscopy compared to the usual care of no video intervention.
Additional locations may be listed on ClinicalTrials.gov for NCT05458986.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Create a low health literacy and culturally-competent video intervention that addresses fear of follow-up colonoscopy completion.
II. Determine the feasibility and acceptability of a video intervention among a safety-net population with abnormal FIT results who have yet to complete a colonoscopy.
III. Determine the impact of a video intervention on patient fear, knowledge, self-efficacy, and intent to complete a follow-up colonoscopy among safety-net patients at HIMC with abnormal FIT results who have yet to complete a colonoscopy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients watch an educational video about the importance of abnormal FIT results, the implications if follow-up colonoscopy is not completed, and demonstrate the steps to complete a colonoscopy.
ARM 2: Patients receive usual care and do not watch the educational video.
After completion of study, patients are followed for 12 months after their abnormal FIT result.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorRachel B. Issaka
