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

基本信息

批准号：
10617207
负责人：
SCOTT A IRWIN
金额：
$ 62.33万
依托单位：
CEDARS-SINAI MEDICAL CENTER
依托单位国家：
美国
项目类别：
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/10617207
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 Educational process of instructing Enrollment Esophagus Esthesia Evidence based treatment Eye Functional Magnetic Resonance Imaging Funding Gastrointestinal tract structure Goggles Harm Reduction Helping to End Addiction Long-term Hepatobiliary High Performance Computing Home Hospitalization Hydromorphone Impairment Intervention Intestines Life Malignant Neoplasms Malignant neoplasm of gastrointestinal tract Meditation Modality Morbidity - disease rate Musculoskeletal Pain Nausea Opioid Opioid Analgesics Outcome Pain Pain Measurement Pain management Pancreas Patient Outcomes Assessments Patient Selection Patients Persons Photic Stimulation 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 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

项目摘要

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.

项目概要消化道恶性肿瘤患者经常会出现剧烈且持续的腹痛，对身体、情感和社会功能以及健康相关的生活质量 (HRQOL) 产生负面影响。尽管内脏癌疼痛造成巨大负担，但现有疗法在提供安全治疗方面的能力有限。当其他治疗无法提供足够的镇痛效果时，患者经常转向阿片类药物。镇痛，但经常发现阿片类药物在有效减轻或改善疼痛方面也达不到要求 HRQOL。对于那些确实通过阿片类药物实现有效镇痛的人来说，他们仍然承担着巨大的风险。此外，在许多情况下，阿片类药物会损害肠道功能，并可能导致病情恶化—— 因此，在控制消化道内脏疼痛方面存在着重大差距。恶性肿瘤；以最大限度地为患者带来利益的方式解决这一证据差距至关重要最大限度地减少伤害风险。治疗虚拟现实 (VR) 已成为一种有前途且基于证据的治疗方式 VR 的用户佩戴一副护目镜，眼睛前面有一个近距离屏幕，可以产生一种视觉效果。迄今为止，VR 仅限于短期体验。此外，针对癌症疼痛的临床试验仅限于基于理论的 VR 模式。分心，例如采用接受与承诺疗法（ACT）的 VR 为了弥合这些差距，本研究旨在：(1) 评估沉浸式 VR 的影响。患者报告的结果 (PRO)，包括疼痛、活动指标和阿片类药物使用情况消化道恶性肿瘤引起的内脏疼痛；(2) 评估 PRO、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 疗法之间的比较；(3) 确定患者层面的 VR 预测因素内脏癌疼痛的治疗反应。为了实现这些目标，该研究将测量 360 名患者的 PRO 和阿片类药物的使用情况，这些患者随机分为 3 组组并在注册后对其进行 60 天的跟踪：(1) 增强型 VR 组接受基于技能的 VR；(2) 基于分心的 VR 组接收患者选择的 VR 视频；(3) 使用 VR 的 VR 假对照组；具有 2D 内容的耳机。研究结果将为实施内脏癌 VR 的最佳实践提供参考。疼痛管理并指导选择适合患者的体验。