Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT04907643
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • PICO G2 4k — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 5, 2021
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Mar 16, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Virtual Reality Program A
    This arm will include software that provides immersive skills-based content for pain reduction.
  • Experimental: Virtual Reality Program B
    This arm will include software that provides immersive distraction based content for pain reduction.
  • Sham Comparator: Virtual Reality Program C
    This arm will include software that provides nonimmersive distraction based content for pain reduction.

Primary Outcome Measure

Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain over 30 days from the baseline [ Time Frame: Over 30 days from the baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Karisma Kothari, MD
[email protected]
310-423-0714

Find similar trials in Los Angeles, CA

By condition
Neuroendocrine tumorsColorectal cancerLiver cancerGastric cancer
By specialty
OncologyGI oncologyHepatology
By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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