This clinical trial compares audio brochures and video brochures to usual care for increasing colorectal cancer (CRC) screening among adults living in Appalachia. Adults living in rural Appalachia experience increased rates of CRC, possibly due to the unique barriers to screening this population faces, such as lower socioeconomic status, limited health literacy, and less access to healthcare. The fecal immunochemical test (FIT) is a common CRC screening technique which allows individuals to complete the test at home and mail the kit back. A limitation of the current process for FIT screening outreach is that the instruction materials are heavy in text and not appropriate for individuals with limited health literacy. The audio and video brochures used in this clinical trial are instruction materials that have been specially designed to be appropriate for individuals of all health literacy levels. Providing these audio and video brochures with the FIT kits may increase CRC screening among adults living in Appalachia, compared to usual care.
PRIMARY OBJECTIVE: I. Conduct a pilot study of the two developed mail-based FIT outreach interventions versus (vs.) mailed usual care materials to establish acceptability and obtain preliminary efficacy data on increasing CRC screening. OUTLINE: Participants are randomized to 1 of 3 arms. ARM I: Participants receive the FIT kit and usual care on study. ARM II: Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. ARM III: Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
94
Receive usual care
Receive FIT kit
Receive audio brochure
Receive video brochure
Receive scheduled reminder
Ancillary studies
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Number of Participants to Return Fecal Immunochemical Test (FIT)
Will estimate FIT return using proportions for each study group. Both comparisons (each intervention compared to control) will be a two-sample test of proportions (intent-to-treat analysis) using a one-sided alpha of 0.1 due to the preliminary nature of the study.
Time frame: At 2 months
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