The ASPIRES Study: Activating Cancer Survivors and their Primary Care Providers to Increase Colorectal Cancer Screening

Project Summary Childhood cancer survivors treated with abdominal or pelvic radiotherapy (RT) are almost four times more likely to develop colorectal cancer (CRC) compared to the general population with their elevated risk evident by the age of 30 years with no plateau. Since earlier detection of precancerous lesions (i.e. adenomas) or CRC is strongly associated with improved survival, screening with colonoscopy or multitarget stool DNA testing (mt- sDNA) with a colonoscopy after a positive test is recommended starting at age 30. Unfortunately, the vast majority of survivors at high-risk for CRC are not adherent to recommended screening. Magnifying this problem, most childhood cancer survivors are no longer followed at a cancer center, are unaware of their risks and are being followed by primary care providers (PCPs) who are not informed about the recommended follow-up care. In order to improve adherence to CRC screening guidelines in high-risk childhood cancer survivors, we propose the ASPIRES (Activating cancer Survivors and their Primary care providers to Increase coloREctal cancer Screening) Study, which is the first known intervention to attempt to increase CRC screening rates in this population using a remote digital mHealth intervention. This is a 3-arm randomized controlled trial to evaluate the utility of patient activation with and without added PCP activation to increase CRC screening. We propose to randomize 315 survivors, who are at least 30 years of age, with a history of abdominal or pelvic radiation for a childhood cancer and without a history of CRC. The primary outcome is obtaining CRC screening with colonoscopy or mt-sDNA during the 12-month study period. We will determine the comparative effectiveness of (1) a mHealth patient activation intervention and (2) patient activation plus PCP activation, compared to control. Secondary aims include (1) conducting a multi-stakeholder mixed-methods Consolidated Framework for Implementation Research (CFIR)-informed evaluation to understand patient, provider and system factors associated with uptake of the intervention, to explore enablers and barriers to uptake of CRC screening, and to generate recommendations for future adaptation, scalability and sustainability; (2) identify potential moderators and mediators of uptake of CRC screening; and (2) estimate the cost-effectiveness of the intervention. The proposed ASPIRES Study brings together a research team with necessary expertise and experience in survivorship, CRC screening, dissemination and implementation, and mHealth intervention research with the unique resource of the 31-institution Childhood Cancer Survivor Study (CCSS). Notably, the CCSS represents the single largest cohort of survivors in the target population and the infrastructure to conduct the proposed study. Results from this intervention will have important implications for patients at high-risk for CRC and we expect that findings from this study will provide the evidence for implementation and dissemination of our CRC screening interventions targeting these populations.