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

虚拟现实治疗胃肠癌疼痛的随机对照试验可改善患者报告的结果

• 批准号: 10383704
• 负责人: SCOTT A IRWIN
• 金额: $ 68.02万
• 依托单位: CEDARS-SINAI MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-05 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10383704
• 关键词: 3D world; Abdominal Pain; Absence of pain sensation; Acute Pain; Address; Biofeedback; Biometry; Brain; Breathing Exercises; Cancer Etiology; Cancer Pain Management; Cessation of life; Clinical; Cognitive Therapy; Colorectal; Complex; Control Groups; Devices; Enrollment; Esophagus; Esthesia; Evidence based treatment; Eye; Functional Magnetic Resonance Imaging; Funding; Gastrointestinal tract structure; Goggles; Harm Reduction; Health Status; Helping to End Addiction Long-term; Hepatobiliary; High Performance Computing; Home; Hydromorphone; Immersion; Impairment; Intervention; Intestines; Malignant Neoplasms; Malignant neoplasm of gastrointestinal tract; Meditation; Modality; Morbidity - disease rate; Musculoskeletal Pain; Nausea; Opioid; Opioid Analgesics; Outcome; Pain; Pain management; Pancreas; Patient Outcomes Assessments; Patient Selection; Patients; Persons; Physical Function; Quality of life; Randomized; Randomized Controlled Trials; Research; Risk; Self Efficacy; Sensory; Social Functioning; Social support; Stimulus; Study Skills; Technology; Testing; Therapeutic; Treatment Efficacy; Treatment-Related Cancer; United States National Institutes of Health; Visceral; Visceral pain; Visual Cortex; Work; base; biopsychosocial; cancer clinical trial; cancer diagnosis; cancer pain; chronic musculoskeletal pain; chronic pain; clinically significant; comorbidity; comparative effectiveness study; cost; cybersickness; distraction; emotional functioning; experience; falls; functional status; health related quality of life; healthy volunteer; improved; mindfulness; mortality; negative affect; opioid use; pain catastrophizing; pain reduction; pain relief; pain score; patient subsets; post intervention; prescription opioid; primary outcome; risk minimization; satisfaction; secondary outcome; skills; sociodemographic factors; theories; treatment response; virtual reality; virtual reality environment; virtual reality headset

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.

项目摘要 消化道恶性肿瘤的患者经常经历严重且不舒服的腹部partathat 负面影响身体，情感和社会功能以及与健康相关的生活质量（HRQOL）。 尽管内脏癌症的疼痛负担很大，但可用的疗法仍有其安全的能力 和有效的镇痛药。 镇痛，但经常发现阿片类药物在提供有意义的可支配恐惧的疼痛orimproving方面也没有 HRQOL。 在许多卡斯中，与毒品相关的发病率和死亡率进一步，阿片类药物会损害肠的功能 不是减轻腹部疼痛。 恶性肿瘤至关重要 最大程度地减少伤害风险。 治疗性虚拟现实（VR）已成为一种有前途和基于证据的治疗方式 癌症疼痛。 迄今为止，VR被运输到救生型世界中。 此外，对基于理论的VR模式的临床试验有限 分散注意力，例如VR，将接受和委托治疗（ACT）与成分的组成部分 生物反馈和正念弥合这些差距，本研究试图：（1） 在患者报告的结果（PRO）中，患者的疼痛，活动指标和阿片类药物使用 消化道恶性肿瘤的内脏疼痛； 在基于技能的VR疗法与干扰疗法之间 内脏癌症疼痛的治疗反应。 为了解决这些目的，该研究将衡量360名随机分组360名患者的优点和阿片类药物使用 小组并在注册后60天关注：（1）增强的VR组接受基于技能的VR； 基于分心的VR组接受患者选择的VR视频；（3）使用VR 带有二维内容的耳机结果将为内脏癌的工具提供最佳实践 疼痛管理和指导患者量身定年经验的选择。