Full Research Project 1: Testing the Efficacy of an eHealth Decision Support Tool to Help Cancer Patients Make informed Decisions About Tumor Genomic Testing

Project Summary Full Research Project 1 – Genomic Testing The use of tumor genomic profiling (TGP) to identify potential cancer treatments can also identify secondary hereditary risks the patient was unaware of. ASCO policy mandates communication of TGP risks and elicits patient preferences for managing these types of results. Some populations in our institutional catchment areas have increased cancer risk and mortality but are especially vulnerable to obstacles that would impede optimal decision making about secondary genetic risks. The primary goal of this study is to evaluate the efficacy of an electronic health (eHealth) decision support tool (DST) to improve informed decision making among patients of the institutional catchment area. This proposal builds on current RCT results of testing an eHealth DST called Gene Pilot and formative work with catchment area patients funded by the pilot mechanism of the current U54 Partnership. These studies use innovative commercial marketing methods to address TGP concerns, encourage informed decision making, and promote communication with providers about preferences for secondary genetic information. Grounded in the Ottawa Framework, the study will determine the efficacy of a revised DST, Gene PilotLX, compared to traditional decision support. Specific aims are: 1. Revise the Gene Pilot tool to reflect formative work. We will use formative results and establish Community and Scientific Advisory Boards to revise content based on formative findings. We will then conduct user testing with 25 cancer patients; 2. Test the impact of Gene PilotLX in a randomized trial. We will conduct a fully powered RCT with 232 cancer patients at four oncology sites in the catchment area. Intervention participants will have access to Gene PilotLX via a tablet or personal device; the comparison arm will receive non-targeted education materials about TGP. Primary outcomes include decision preparedness, decisional conflict, and communication of preferences with a doctor. Secondary outcomes include communication of preferences with family and changes in perceptions of TGP. H1: Those in the Gene PilotLX arm will have greater reduced decisional conflict and higher decision preparedness compared to the non-targeted decision aid. H2: Those in the Gene PilotLX arm will report communicating TGP preferences with their oncologist more when compared to the non-targeted information arm; and 3. Determine whether the effects of Gene PilotLX on primary and secondary outcomes are moderated by cultural values. H3: Gene PilotLX will have a larger effect on primary outcomes for those holding stronger values of family and those who are more acculturated than those with lower values. The reverse will occur with the value of fatalism. In line with the U54’s vision, this study focuses on specific challenges to engaging and communicating about TGP, thereby improving informed decision making in a population at high risk of cancer.