Background/Objectives: Informed consent is a crucial part of the clinical trial enrollment process in which patients are asked to understand and provide approval for medical interventions. Consent forms can be complex and hinder patient comprehension, highlighting the need for novel tools to improve the patient enrollment experience. This feasibility study aimed to develop an immersive technology to enroll human subjects in oncology clinical trials and provide 3D avatar-based informed consent in a virtual reality (VR) environment.Methods: Clinical feasibility and the effects of head-mounted VR devices on motion sickness and educational quality were evaluated in adult oncology patients enrolled in an intravenous (IV) port placement intervention study. Participants received before- and after-questionnaires to measure their understanding of the information received in VR. A follow-up questionnaire was given four weeks post-consent to measure knowledge retention.Results: Clinical staff reported that VR technology was manageable to use. Among 16 adult participants, all reported that VR was well tolerated with no motion sickness. The mean pre-intervention knowledge score was 64.6%, with an immediate post-intervention knowledge score of 97.9%. A mean knowledge score of 93.3% four-weeks post-consent was observed among 10/16 participants who completed a follow-up questionnaire.Conclusions: These findings support that VR is well tolerated and effective at delivering information during the informed consent process for oncology clinical trials. Key limitations include the small sample size and single clinical population. Further trials are warranted to compare efficacy over traditional consenting mechanisms and include more diverse clinical populations among a wider participant pool.
背景/目的：知情同意是临床试验入组流程中的关键环节，患者需在此过程中理解医疗干预措施并予以确认。传统同意书内容复杂可能影响患者理解，凸显了采用创新工具改善患者入组体验的必要性。本可行性研究旨在开发一种沉浸式技术，用于肿瘤临床试验受试者入组，并在虚拟现实环境中提供基于三维虚拟形象的知情同意流程。 方法：在一项静脉输液港置入干预研究中，对入组的成年肿瘤患者进行临床可行性评估，并考察头戴式VR设备对晕动症及教育质量的影响。参与者需在VR干预前后填写问卷以评估其对所获信息的理解程度，并在知情同意四周后通过随访问卷测量知识保留情况。 结果：临床工作人员反馈VR技术易于操作管理。在16名成年参与者中，所有受试者均表示VR体验耐受性良好且未出现晕动症状。干预前知识测试平均得分为64.6%，干预后即时测试得分达97.9%。在完成随访问卷的10名参与者中，知情同意四周后的平均知识保留得分为93.3%。 结论：研究结果表明在肿瘤临床试验知情同意过程中，VR技术具有良好的耐受性且能有效传递信息。主要局限性包括样本量较小及临床人群单一。未来需开展进一步试验，比较VR与传统知情同意机制的效果差异，并在更广泛的参与者群体中纳入更多样化的临床人群。
肿瘤(癌症)患者之家