Purpose: The overall goal of this study is to develop methods and gather preliminary data for a future R01 study that will test the efficacy of fecal immunochemical test (FIT) screening and telephone barriers counseling in rural Appalachia. ? Design: A prospective, clinic-based, participatory design will be used to determine acceptability of a provider-recommended, take-home FIT kit and screening adherence with and without follow-up telephone barriers counseling. The telephone barriers counseling is based upon the Cognitive-Social Health Information Processing (C-SHIP) theoretical model. ? Methods: A purposive sample of patients age 50 and older, at average CRC risk, and currently non- adherent for CRC screening (n=300) attending a regularly-scheduled, office visit in two rural, Appalachian primary care clinics will be recruited and complete the baseline questionnaire in the clinic waiting room. During the patient's exam/consultation the provider will recommend CRC screening and offer a take-home, FIT screening kit and educational brochure on CRC with a request for the completed test to be mailed to a central lab for processing within one week. Non-compliers will receive a single telephone barriers counseling session to address barriers reported at baseline and during the counseling session. Those who remain non- adherent following barriers counseling will receive a second, brief telephone assessment to determine reasons for non-compliance and encourage completion of screening. ? Analysis: Primary outcomes are patient acceptability of the intervention and screening adherence rates with and without barriers counseling. Secondary outcomes are CRC-related knowledge and barriers to screening assessed at baseline and 3-months follow-up. Screening outcomes will be evaluated by examining percentages of completed screening following provider recommendation of screening and following barriers counseling, compared to those in the literature. A process evaluation will assess overall feasibility of the intervention. ? Dissemination: Findings will be disseminated through the participating clinics and their local cancer coalitions, scientific meetings, and a manuscript submitted to a peer-reviewed journal. Findings will also be used as a foundation for the development of future studies and applications for extramural research support. ? Contributions: This research will provide an important contribution to the understanding of patient barriers to CRC screening, the primary care physician's role in increasing CRC screening, and the discovery of effective cancer control methods that ultimately may help reduce the cancer burden in Appalachia. ? ? ? ?
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