肿瘤患者在新辅助免疫治疗临床试验中的角色感知及体验的质性研究

目的 从患者视角深入了解已完成新辅助免疫治疗临床试验患者在其参与过程中的角色感知和体验,为新辅助免疫治疗方案临床试验设计中增加患者视角,进一步促进新辅助免疫治疗用药的发展及提升我国肿瘤患者的整体诊治水平提供参考和依据。方法 采用现象学研究方法,以目的抽样选取13例已完成新辅助免疫治疗临床试验患者,进行半结构式访谈,并运用Colaizzi7步分析法对资料进行分析。结果 患者参与新辅助免疫治疗临床试验的角色感知归纳为4个主题,分别为药物发展的“试验品”、新药实践的志愿者与促进者、新药方案的参与者与评价者、医学进步的受益者。患者在新辅助免疫治疗临床试验中的参与体验归纳为3个主题,分别为来自研究团队的关怀,新辅助免疫临床试验过程中的担心与困扰（免疫不良反应的不确定性、医疗资源的不便捷性、随访检查的频繁性）,医院、社会缺少对临床试验的相关宣传（试验获取途径受限、积极与支持环境的欠缺、尊重与理解的需求）。结论 患者在新辅助免疫治疗临床试验参与中尚需改善其“试验品”的负性感知,参与体验也反映了目前新辅助免疫治疗临床试验中存在的相关问题,护理人员需要重视患者在试验参与中的体验,针对患者需求完善健康教育方案,提升社会支持,进而提高我国新辅助免疫治疗临床试验的质量。

Role Perception and Participation Experience of Tumor Patients in Clinical Trials of Neoadjuvant Immunotherapy: A Qualitative Study

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.