关键词: 肿瘤患者, 新辅助治疗, 免疫检查点抑制剂, 角色, 体验, 质性研究

Abstract: Objective To understand the role perception and experience of patients who have completed clinical trials of neoadjuvant immunotherapy, so as to provide reference for designing clinical trial of neoadjuvant immunotherapy from the perspective of patients, further promoting the development of neoadjuvant immunotherapy drugs and improving the overall diagnosis and treatment of tumor patients in China. Methods Phenomenological method was used and with purposive sampling, 13 patients who had completed the clinical trial were selected for semi-structured interviews, and the data were analyzed by Colaizzi 7-step analysis method. Results Patients’ role perception can be summarized into four themes: test samples of drug development, volunteers and promoters of new drug practice, participants and evaluators of new drug programs, and beneficiaries of medical progress. Patients’ participation experience in clinical trial of neoadjuvant immunotherapy can be summarized into three themes: care from the research team, worries and troubles in the clinical trial of neoadjuvant immunotherapy (uncertainty of adverse immune reactions, inconvenience of medical resources, and frequency of follow-up), inadequate publicity for clinical trials (limited access to trials, lack of positive and supporting environment, and need for respect and understanding). Conclusion Patients’ negative perception of test samples in the clinical trial of neoadjuvant immunotherapy needs to be improved. The participation experience also demonstrates problems existing in the current clinical trials of neoadjuvant immunotherapy. Nurses need to pay attention to the experience of patients in the trials, promote health education according to the needs of patients, improve social support, and then improve the quality of clinical trials of neoadjuvant immunotherapy in China.

Key words: tumor patient, neoadjuvant therapy, Immune checkpoint inhibitors, role, experience, qualitative research