Ideally, patient-centered trial information material encourages the discussion with the treating physician, and helps patients making trade-offs regarding treatment decisions In a situation of possible equivalent treatment options in terms of overall survival (OS), it can make it easier to weigh up advantages and disadvantages. Preferences for choice of treatment in esophageal cancer (EC) are complex, and no standardized assessment tools are available. We will explore patient’s factors for treatment choice and develop a comprehensive patient information leaflet for the inclusion into randomized controlled trials (RCT) on EC. We conduct a cross-sectional, observational study based on a mixed-methods design with patients suffering from non-metastatic EC with post-neoadjuvant complete response after neoadjuvant chemotherapy (nCT) or neoadjuvant chemoradiation (nCRT), to develop patient-centered trial information material. This pilot study is performed in a concept development phase and a subsequent pilot phase. We start with patient interviews (n = 10–15) in the concept development phase to evaluate patients’ needs, and develop a Preference and Decision Aid Questionnaire (PDAQ). We pre-test the PDAQ with another n = 10 patients with EC after nCT or nCRT, former patients from a self-help organization, and n = 10 medical experts for their comments on the questionnaire. In the pilot phase, a multicenter trial using the PDAQ and additional measures is carried out (n = 120). Based on evidence of a possible equivalence in terms of OS of the treatment options “surgery as needed” and “surgery on principle” in patients with post-neoadjuvant complete response of EC, this pilot study on patient participation is conducted to assess patient’s needs and preferences, and optimize patients’ inclusion in a planned RCT. The aim is to develop patient-centered trial information material for the RCT to increase patients’ consent and compliance with the randomized treatment. The trial is registered at the German Clinical Trials Register (DRKS00022050, October 15, 2020).

理想情况下，以患者为中心的试验信息材料鼓励与治疗医师的讨论，并帮助患者在治疗决策方面做出权衡优点和缺点。食管癌 (EC) 治疗选择的偏好很复杂，并且没有可用的标准化评估工具。我们将探索患者的治疗选择因素，并制定一份全面的患者信息手册，以纳入 EC 的随机对照试验 (RCT)。我们进行横断面，基于混合方法设计的观察性研究，研究对象为新辅助化疗 (nCT) 或新辅助放化疗 (nCRT) 后新辅助完全缓解的非转移性 EC 患者，以开发以患者为中心的试验信息材料。该试点研究在概念开发阶段和随后的试点阶段进行。我们从患者访谈开始（n= 10–15) 在概念开发阶段评估患者的需求，并制定偏好和决策辅助问卷 (PDAQ)。我们用另一个预测试 PDAQn = 10 名在 nCT 或 nCRT 后患有 EC 的患者，来自自助组织的前患者，以及n = 10 位医学专家对问卷的评论。在试点阶段，使用 PDAQ 和其他措施进行了多中心试验（n= 120)。基于对 EC 新辅助治疗后完全缓解患者的治疗方案“按需手术”和“原则手术”在 OS 方面可能等效的证据，进行了这项关于患者参与的初步研究，以评估患者的需求和偏好，并优化患者纳入计划中的 RCT。目的是为 RCT 开发以患者为中心的试验信息材料，以增加患者对随机治疗的同意和依从性。该试验已在德国临床试验登记处注册（DRKS00022050，2020 年 10 月 15 日）。