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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.

项目总结