Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Project Number5R01CA252211-04
Former Number1R01CA252211-01
Contact PI/Project LeaderSPIEGEL, BRENNAN Other PIs
Awardee OrganizationCEDARS-SINAI MEDICAL CENTER
Description
Abstract Text
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.
Public Health Relevance Statement
PROJECT NARRATIVE
Patients with malignancy of the digestive tract often experience severe and unremitting abdominal pain that
negatively affects physical, emotional, and social function. 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 quality of life. This study will test the impact of therapeutic virtual reality
(VR)—an evidence-based treatment for pain—as a non-pharmacologic adjunctive treatment for cancer-related
pain in patients with malignancies of the digestive tract.
NIH Spending Category
No NIH Spending Category available.
Project Terms
3D worldAbdominal PainAbsence of pain sensationAcute PainAddressBiofeedbackBiometryBrainBreathing ExercisesCancer EtiologyCancer Pain ManagementCessation of lifeClinicalCognitive TherapyColorectalComplexControl GroupsDevicesEducational process of instructingEnrollmentEsophagusEsthesiaEvidence based treatmentEyeFunctional Magnetic Resonance ImagingFundingGastrointestinal tract structureGogglesHarm ReductionHelping to End Addiction Long-termHepatobiliaryHigh Performance ComputingHomeHospitalizationHydromorphoneImpairmentInterventionIntestinesLifeMalignant NeoplasmsMalignant neoplasm of gastrointestinal tractMeditationModalityMorbidity - disease rateMusculoskeletal PainNauseaOpioidOpioid AnalgesicsOutcomePainPain MeasurementPain managementPancreasPatient Outcomes AssessmentsPatient SelectionPatientsPersonsPhotic StimulationPhysical FunctionQuality of lifeRandomizedRandomized, Controlled TrialsResearchRiskSelf EfficacySensorySocial FunctioningSocial supportStimulusStudy SkillsTechnologyTestingTherapeuticTreatment EfficacyTreatment-Related CancerUnited States National Institutes of HealthVisceralVisceral painVisual CortexWorkbiopsychosocialcancer clinical trialcancer diagnosiscancer painchronic musculoskeletal painchronic painclinically significantcomorbiditycomparative effectiveness studycostcybersicknessdistractionemotional functioningexperiencefunctional statushealth related quality of lifehealthy volunteerimprovedmindfulnessmortalitynegative affectopioid usepain catastrophizingpain reductionpain reliefpain scorepatient subsetspost interventionprescription opioidprimary outcomerisk minimizationsatisfactionsecondary outcomeskillssociodemographic factorstheoriestreatment responsevirtual realityvirtual reality environmentvirtual reality headset
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