Background/Objectives: Informed consent is crucial in medical practice, especially for complex treatments such as postoperative radiotherapy for patients with breast cancer. Conventional consent procedures are often based on verbal declarations with a highly condensed but nevertheless large amount of information, which can exceed the recording capacity of patients and lead to misunderstandings. The aim of this study was to develop and test an educational video on breast cancer patients to enhance the informed consent process by improving patients’ understanding and reducing the duration of the subsequent consultation. Methods: The educational video was created after the underlying content was determined by a modified Delphi method in which a panellist of radiation oncologists, nurses, radiation therapists, and former patients participated in successive rounds of topic scoring. After achieving content consent, the video included 19 items to cover key aspects of postoperative radiotherapy in a patient-friendly manner. Fifty breast cancer patients scheduled for postoperative radiotherapy were randomised to watch the video prior to their verbal consultation (n= 25) or to the control group participating in the traditional informed consent process only (n= 25). The duration of the informed consent processes in both arms was recorded. To assess the educational effect of the video, a multiple-choice test was created. In addition, patients’ satisfaction was recorded using a separate questionnaire. Both questionnaires were completed by the patients one to two hours after signing the consent form. Results: The patients in the video group evidenced significantly higher knowledge scores than those who received standard verbal explanations (median number of correct answers 9 vs. 8 out of 10,p= 0.0039). The whole informed consent process was also completed faster in the video group (mean duration 34.7 vs. 46.2 min,p< 0.001). Median satisfaction scores were high in both groups (34 vs. 33 out of 35 points), with no significant differences observed (p> 0.05). Conclusion: The educational video effectively improved patient understanding and streamlined the informed consent process without compromising patients’ satisfaction. This approach also helps to standardise the delivery of complex medical information, and it can also be adapted to improve the informed consent process for other cancer treatments.
背景/目的：知情同意在医疗实践中至关重要，尤其对于乳腺癌患者术后放疗等复杂治疗。传统知情同意流程通常依赖口头告知，信息高度浓缩但内容庞杂，可能超出患者的信息接收能力并导致误解。本研究旨在开发并测试针对乳腺癌患者的教育视频，通过提升患者理解程度、缩短后续咨询时长来优化知情同意流程。方法：通过改良德尔菲法确定视频核心内容，由放射肿瘤科医师、护士、放射治疗师及康复患者组成的专家小组参与多轮主题评分。达成内容共识后，视频最终包含19个以患者友好方式呈现术后放疗关键要点的项目。将50名计划接受术后放疗的乳腺癌患者随机分为两组：视频组（n=25）在口头咨询前观看教育视频，对照组（n=25）仅参与传统知情同意流程。记录两组知情同意过程耗时，并通过设计多选题评估视频教育效果。另采用独立问卷收集患者满意度数据，两份问卷均在签署同意书后1-2小时内完成。结果：视频组患者知识测试得分显著高于接受标准口头解释的对照组（中位正确题数9/10 vs. 8/10，p=0.0039）。视频组完成整个知情同意流程耗时更短（平均时长34.7分钟 vs. 46.2分钟，p<0.001）。两组满意度评分中位数均处于高位（34/35分 vs. 33/35分），未观察到显著差异（p>0.05）。结论：教育视频在保障患者满意度的前提下，有效提升了患者认知水平并优化了知情同意流程效率。该方法有助于实现复杂医疗信息传递的标准化，亦可推广应用于其他癌症治疗的知情同意流程改进。
肿瘤(癌症)患者之家