RecruitingNot ApplicableNCT04907643

Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

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


Sponsor

Cedars-Sinai Medical Center

Enrollment

360 participants

Start Date

Oct 5, 2021

Study Type

INTERVENTIONAL

Conditions

Liver CancerBiliary Tract CancerColon CancerRectal CancerEsophagus CancerPancreas CancerGastric (Stomach) CancerCancer PainStomach CancerAnal CancerBile Duct CancerGallbladder CancerSmall Intestine CancerRectum CancerStomach Cancer RecurrentLiver Cancer Stage IVNeuroendocrine TumorGastrointestinal NeoplasmsAppendix CancerColon Cancer Stage IIIPeritoneum CancerVisceral PainCancer of Gastrointestinal TractPeritoneal CancerGastrointestinal Cancer MetastaticGastrointestinal Cancers - AnusGastrointestinal Cancers - StomachGastrointestinal Cancers - ColorectalGastrointestinal Cancers - Small IntestineSmall Intestine Cancer Stage IIISmall Intestine Cancer Stage IVSmall Intestine Cancer, RecurrentPancreas Cancer, Stage IIIPancreas Cancer, Stage IVPancreas Cancer, MetastaticPancreas Cancer, RecurrentLiver Cancer Stage IIIaLiver Cancer Stage IIIbLiver Cancer Stage IIIcColon Cancer Stage IVStomach Cancer Stage IIIStomach Cancer Stage IVRectum Cancer, RecurrentGastrointestinal Cancers - LiverAnal Cancer Stage IIIAnal Cancer Stage IVAnal Cancer RecurrentAnal Cancer MetastaticAnal Cancer, Stage IIIAAnal Cancer, Stage IIIBAmpullary CancerBile Duct Cancer Stage IIIBile Duct Cancer Stage IVBile Duct Cancer Stage IVABile Duct Cancer Stage IVBBile Duct Cancer RecurrentCarcinoid TumorCarcinoid Tumor of PancreasCarcinoid Tumor of Large IntestineCarcinoid Tumor of GI SystemCarcinoid Tumor of ColonCarcinoid Tumor of LiverCarcinoid Tumor of CecumCarcinoid Tumor of IleumCarcinoid Tumor of RectumCarcinoid Tumor of the Small BowelCarcinoid Tumor of the StomachLarge Intestine CancerEsophagus Cancer, Stage IIIEsophagus Cancer, Stage IVEsophagus Cancer, RecurrentGallbladder Cancer Stage IIIGallbladder Cancer Stage IVEsophagus Cancer, Stage IEsophagus Cancer, Stage IIGallbladder Cancer Stage IGallbladder Cancer Stage IIBile Duct Cancer Stage IBile Duct Cancer Stage II

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). 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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period
  • Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible
  • Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score
  • Ability to read and write in English

Exclusion Criteria4

  • Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments
  • Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.
  • Have brain metastases
  • Have a prognosis of \<3 months from the time of enrollment per treating oncologist

Interventions

DEVICEPICO G2 4k

Participants will use the Pico G2 4K VR audio and visual head-mounted device. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.


Locations(1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

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NCT04907643


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