A Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of an Intervention to Promote Guideline-Concordant Colorectal Cancer Surveillance

ABSTRACT The transition from curative-intent treatment to survivorship can be an overwhelming and confusing time for patients with colorectal cancer (CRC). Surveillance for cancer recurrence is a critically important part of CRC survivorship care, as CRC recurrences are common and may be curable if detected early. However, up to 60% of the 1.5 million CRC survivors in the U.S. fail to receive surveillance as recommended by the American Society for Clinical Oncology and the National Comprehensive Cancer Network. Among CRC survivors, there are gaps in knowledge about the purpose of surveillance and the risk of cancer recurrence. Particularly because CRC surveillance is a “package” of three separate components (CEA blood test, imaging, endoscopy), knowledge about surveillance is key to survivors’ self-efficacy for managing surveillance. To improve knowledge about and self-efficacy for managing surveillance and to promote effective supporter engagement in surveillance, we developed an intervention prototype, Current Together After Cancer (CTAC), for CRC survivors and their supporters. The objectives of the R01 are to evaluate the effectiveness of CTAC in 1) improving knowledge about and self-efficacy for managing surveillance and 2) improving receipt of surveillance, while assessing factors that influence its implementation in diverse community oncology practices. Our proposed study will leverage the resources of the NCI Community Oncology Research Program (NCORP) and the SWOG Cancer Research Network to conduct a pragmatic randomized controlled trial of CTAC vs. static online cancer survivorship information in 654 survivors with Stages II and III CRC. Survivors will be randomized 2:1 to the CTAC arm and will be given the option to invite their supporter to participate with them in the CTAC intervention. This innovative study has the following aims: (1) To determine the effect of CTAC on key clinical outcomes: knowledge about and self-efficacy in managing surveillance, and receipt of surveillance; (2) To explore the association of supporter inclusion in CTAC with survivors’ knowledge about and self-efficacy for managing surveillance, receipt of surveillance, and satisfaction with supporter engagement in surveillance; (3) To assess factors related to use of CTAC across diverse survivors and community oncology practice settings. Through this series of Aims we expect to demonstrate the effectiveness of CTAC in improving knowledge about and self-efficacy in managing, and receipt of, surveillance in a cohort of survivors of stages II and III CRC. In addition, we expect to obtain new knowledge that will support the future population- based implementation of CTAC. Improving knowledge about and self-efficacy in managing surveillance, and improving receipt of surveillance, will lead to improved clinical outcomes for the large and growing population of CRC survivors.