Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

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.

Conditions

• Cancer Pain
• Visceral Pain
• Gastrointestinal Neoplasms
• Cancer of Gastrointestinal Tract
• Small Intestine Cancer
• Pancreas Cancer
• Liver Cancer
• Colon Cancer
• Biliary Tract Cancer
• Stomach Cancer
• Rectum Cancer
• Peritoneal Cancer
• Gastrointestinal Cancer Metastatic
• Gastrointestinal Cancers - Anus
• Gastrointestinal Cancers - Stomach
• Gastrointestinal Cancers - Colorectal
• Gastrointestinal Cancers - Small Intestine
• Small Intestine Cancer Stage III
• Small Intestine Cancer Stage IV
• Small Intestine Cancer, Recurrent
• Pancreas Cancer, Stage III
• Pancreas Cancer, Stage IV
• Pancreas Cancer, Metastatic
• Pancreas Cancer, Recurrent
• Liver Cancer Stage IIIa
• Liver Cancer Stage IIIb
• Liver Cancer Stage IIIc
• Liver Cancer Stage IV
• Colon Cancer Stage III
• Colon Cancer Stage IV
• Stomach Cancer Stage III
• Stomach Cancer Stage IV
• Stomach Cancer Recurrent
• Rectum Cancer, Recurrent
• Gastrointestinal Cancers - Liver
• Anal Cancer
• Anal Cancer Stage III
• Anal Cancer Stage IV
• Anal Cancer Recurrent
• Anal Cancer Metastatic
• Anal Cancer, Stage IIIA
• Anal Cancer, Stage IIIB
• Appendix Cancer
• Ampullary Cancer
• Bile Duct Cancer
• Bile Duct Cancer Stage III
• Bile Duct Cancer Stage IV
• Bile Duct Cancer Stage IVA
• Bile Duct Cancer Stage IVB
• Bile Duct Cancer Recurrent
• Carcinoid Tumor
• Carcinoid Tumor of Pancreas
• Carcinoid Tumor of Large Intestine
• Carcinoid Tumor of GI System
• Carcinoid Tumor of Colon
• Carcinoid Tumor of Liver
• Carcinoid Tumor of Cecum
• Carcinoid Tumor of Ileum
• Carcinoid Tumor of Rectum
• Carcinoid Tumor of the Small Bowel
• Carcinoid Tumor of the Stomach
• Large Intestine Cancer
• Esophagus Cancer
• Esophagus Cancer, Stage III
• Esophagus Cancer, Stage IV
• Esophagus Cancer, Recurrent
• Gallbladder Cancer
• Gallbladder Cancer Stage III
• Gallbladder Cancer Stage IV
• Gastric (Stomach) Cancer
• Neuroendocrine Tumor
• Peritoneum Cancer
• Rectal Cancer
• Esophagus Cancer, Stage I
• Esophagus Cancer, Stage II
• Gallbladder Cancer Stage I
• Gallbladder Cancer Stage II
• Bile Duct Cancer Stage I
• Bile Duct Cancer Stage II

Interventions

DEVICE

PICO 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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of California, Los Angeles

  collaborator OTHER

• Cedars-Sinai Medical Center

  lead OTHER

Principal Investigators

• Brennan Spiegel, MD, MSHS · Cedars-Sinai Medical Center

• Scott Irwin, MD, PhD · Cedars-Sinai Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-05

Primary Completion

2027-01-01

Completion

2027-03-16

FDA Device

Yes

Countries

• United States

Study Locations