Improving lung cancer decision-making using a conversation tool (iDECIDE): a stepped wedge pragmatic clinical trial

Lung cancer is a leading cause of cancer-related mortality. However, few treatment decision-making resources exist. In this study, we evaluate a low literacy lung cancer treatment conversation tool to enhance shared decision-making (SDM). The Improving Decision-Making Encounters in Lung Cancer (iDECIDE) pragmatic, stepped-wedge cluster randomized trial evaluates the effectiveness of a conversation tool for patients with lung cancer. Our primary outcome is SDM, a multifaceted outcome consisting of decisional conflict (DCS), decision self-efficacy (DSES), satisfaction with communication (COMRADE), and assessment of lung cancer knowledge. SDM is assessed 2 weeks, 3 months, and 6 months after patients’ treatment decision-making encounter. Each measure within the primary outcome will be assessed separately. We began recruiting patients in 2022 from four health care centers and will conduct outcome assessments at four timepoints over 6 months. We aim to recruit 230 patients by 2025. We seek to address the gaps in NSCLC decision-making support using an innovative trial design to determine whether our conversation tool improves SDM and other patient-centered outcomes. Clinical Trial Registration: NCT05407168 (clinicaltrials.gov) Lung cancer is one of the most deadly cancers. Although there are many treatment options, resources exist to help patients make decisions about treatment for their lung cancer. This study evaluates how well a decision aid helps improve decision-making conversations between patients with lung cancer and their providers. In our study, Improving Decision-Making Encounters In Lung Cancer (iDECIDE), we go through a lung cancer treatment decision aid with patients with lung cancer. We also measure patients’ decisional conflict, decision self efficacy, satisfaction with communication, and knowledge about lung cancer. We measure these concepts before patients make a treatment decision, and then 2 weeks, 3 months, and 6 months after they make their treatment decision. We began recruiting patients for our study in 2022 and recruit patients from four different hospitals in the Portland, Oregon area. Our goal is to recruit 230 patients by the end of 2025. We hope to address gaps in decision-making support for patients with lung cancer by evaluating whether our decision aid improves decision-making conversations between patients and providers.