Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

项目总结 消化道恶性肿瘤患者经常经历剧烈而持续的腹痛， 对身体、情感和社会功能以及与健康相关的生活质量(HRQOL)产生负面影响。 尽管内脏癌疼痛带来了沉重的负担，但现有的治疗方法在提供安全的 和有效的止痛。当其他治疗方法不能提供足够的药物时，患者经常转向阿片类药物 止痛，但经常发现阿片类药物也不能提供有意义的疼痛减轻或改善 HRQOL。对于那些确实从阿片类药物中获得有效止痛的人来说，他们仍然承担着巨大的风险。 与阿片类药物相关的发病率和死亡率。此外，在许多情况下，阿片类药物损害肠道功能，并可能恶化- 不是缓解--腹痛。因此，在管理来自消化道的内脏疼痛方面存在着严重的差距。 恶性肿瘤；至关重要的是，以一种使患者受益最大化的方式来解决这一证据差距，同时 将伤害风险降至最低。 治疗性虚拟现实(VR)已经成为一种很有前途的循证治疗方式 癌痛。VR的用户戴着一副护目镜，在眼睛前面有一个近距离屏幕，这创造了一种 被运送到逼真的三维世界的感觉。到目前为止，虚拟现实仅限于短期 癌症疼痛的临床试验。此外，关于基于理论的虚拟现实模式的研究也有限，不仅仅是 分心，例如采用接受和承诺疗法(ACT)的VR，其组件为 生物反馈和正念。为了弥合这些差距，本研究试图：(1)评估沉浸式VR的影响 关于患者报告的结果(PRO)，包括疼痛、活动指标和阿片类药物的使用 消化道恶性肿瘤引起的内脏疼痛；(2)评估专业知识、活动指标和阿片类药物使用的差异。 基于技能的VR疗法与分散注意力的VR疗法之间的关系；以及(3)确定VR患者水平的预测因素 内脏癌痛的治疗反应。 为了达到这些目标，这项研究将测量360名患者的专业药物和阿片类药物的使用情况，这些患者随机分为3组 小组并在注册后跟踪他们60天：(1)接受基于技能的虚拟现实的增强虚拟现实小组；(2) 基于分心的VR组，接收患者选择的VR视频；以及(3)使用VR的VR假对照组 带有2-D内容的耳麦。这一结果将为实施内脏癌VR的最佳实践提供参考 疼痛管理和指导选择患者量身定制的体验。

PROJECT SUMMARY Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Despite the substantial burden of visceral cancer pain, available therapies are limited in their ability to offer safe and effective analgesia. Patients frequently turn to opioids when other treatments fail to provide adequate analgesia, yet often discover that opioids also fall short in delivering meaningful pain reduction or improving HRQOL. For those who do achieve effective analgesia from opioids, they nonetheless assume a substantial risk of opioid-related morbidity and mortality. Further, in many cases, opioids impair bowel function and can worsen— not alleviate—abdominal pain. Hence, there is a critical gap in managing visceral pain from digestive tract malignancies; it is vital to address this evidence gap in a way that maximizes benefits for patients while minimizing the risk of harm. Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain. To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.