Decision-making processes among patients with lung cancer considering participation in neoadjuvant immunotherapy clinical trials: A qualitative grounded theory study.

Objective: As neoadjuvant immunotherapy becomes increasingly incorporated into clinical trial protocols for lung cancer, patients are required to make complex decisions under conditions of uncertainty. However, the dynamic processes underlying their decision-making remain insufficiently understood. Methods: A qualitative study informed by grounded theory methodology was conducted at the Clinical Trial Center of the Cancer Hospital, Chinese Academy of Medical Sciences. In-depth, semi-structured interviews were performed with 16 patients with lung cancer who were undergoing neoadjuvant immunotherapy within clinical trials. Data were analyzed using open, axial, and selective coding to construct a theoretical model of the decision-making process. Results: The decision-making process evolved through five interrelated phases: initiation, deliberation and trade-off, commitment formation, adjustment, and post-decision evaluation. Decision-making satisfaction was shaped by both internal factors (e.g., personal beliefs, perceived risk tolerance, treatment expectations) and external influences (e.g., physician communication, family involvement, trial-related information). Conclusions: We developed a grounded theoretical model describing how patients with lung cancer navigate decisions regarding participation in neoadjuvant immunotherapy clinical trials. The findings highlight the need for stage-specific and culturally sensitive decision support strategies delivered by clinical research teams. Addressing both internal and contextual determinants may enhance decision quality and satisfaction among treatment-naïve patients considering trial participation.