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).