Strategies for Optimizing a Mailed FIT Program in Appalachia

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PROJECT SUMMARY Colorectal cancer (CRC) is the third most common cancer among both men and women and the second leading cause of cancer deaths in the United States (US). CRC screening is now recommended for average- risk adults ages 45-75, yet many adults in the US are not within screening guidelines. One recommended CRC screening approach is annual completion of a fecal immunochemical test (FIT). FIT can be completed at home and sent/returned via mail, making mailed FIT programs a promising way to reach people and increase CRC screening. Such programs may be especially important for geographic regions with lower access to healthcare and lack of public transportation, such as the Appalachian region of the US. Mailed FIT programs have been shown to increase CRC screening, but typically fewer than half of participants in these programs who were sent a FIT returned a completed test. This indicates that mailed FIT programs can be greatly improved upon by addressing common barriers to FIT return. A key next step in this field of research is to identify strategies that can address these barriers and subsequently increase FIT return in mailed programs. Our study team will build on our past research and take this key next step. In doing so, we will partner with health centers in Appalachian counties that are located in a CRC “hotspot” within the US (i.e., clusters of counties with high CRC rates). The proposed study will involve a mailed FIT program (called “FIT Starts at 45”) that includes 500 participants from Appalachia who are underscreened and ages 45-74. We will determine the efficacy and cost-effectiveness of two potential strategies for increasing FIT return: FIT kit materials (enhanced FIT kit that includes a video brochure vs. standard FIT kit) and patient navigation (PN) delivery mode (text message PN vs. telephone PN). In a 2x2 between-subjects factorial randomized trial, each participant will be randomized to one of the following study groups: standard FIT kit plus telephone PN; standard FIT kit plus text message PN; enhanced FIT kit plus telephone PN; or enhanced FIT kit plus text message PN. The proposed study will be one of the most innovative and comprehensive mailed FIT programs to date in the US, with each study aim making a significant research contribution. Aim 1 will determine the efficacy of FIT kit materials and PN delivery mode on increasing FIT return. FIT return will be defined as return of a completed FIT by participants within six weeks of FIT distribution. Aim 2 will determine if efficacy differs across key characteristics of participants and their communities (i.e., moderation). Aim 3 will compare the cost- effectiveness of FIT kit materials and PN delivery mode on increasing FIT return. Results will be impactful by providing an evidence base that can help optimize the design, implementation, scalability, and sustainability of future mailed FIT programs, including our own efforts to disseminate the FIT Starts at 45 program.