A Novel Community-Based Study Promoting Colorectal Cancer Screening in Underserved Appalachian Kentucky Communities: A Study Protocol for a Randomized Control Trial

Colorectal cancer is the second leading cancer cause of death in Kentucky and the United States. Appalachian Kentuckians have the greatest burden of colorectal cancer, higher incidence and mortality from colorectal cancer. While clinical trials have reported the beneficial effects of annual FIT testing comprable to colonoscopy and improved CRC screening with patient navigation, the effectiveness of these approaches in community-based studies remains understudied, particularly among Applachian adults over age 50. To address this concern, the Rural Cancer Prevention Center funded by the CDC's Prevention Research Center offers a two-parallel-arm randomized controlled trial that will compare the effect of a brief, targeted motivational video (video) + community nurse navigator (CNN) outreach intervention versus a video +CNN+targeted patient media enhanced intervention (the patient media adds targeted newsletters and an information-rich social networking site patient portal) to increase the demand for FIT testing, appropriate follow-up colonoscopy, and timely, repeat FIT-testing in a medically underserved population. Approximately 400 adults over 50 who have not had a FIT test in the apst year will be randomly assigned to one of the two study conditions. This innovative research design allows each intervention to serve as the control for the other.  This novel, simultaneous testing of two community-based interventions in a randomized fashion is an economical and yet rigorous strategy that also enhances the acceptability of the project.  The primary outcomes will be 1) patient acceptance and return of FIT kits and 2) CRC screening rates at six months.