Actively Recruiting
Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Led by Cedars-Sinai Medical Center · Updated on 2026-02-20
360
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
Sponsors
C
Cedars-Sinai Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of virtual reality (VR) technology to help manage severe abdominal pain in patients with digestive tract cancers. This study seeks to compare how different VR approaches affect patient-reported outcomes such as pain levels, physical activity, and opioid use. The trial aims to identify which type of VR therapy—skills-based, distraction-based, or a non-immersive sham—offers the best support for managing visceral cancer pain and to understand which patients might benefit most from VR treatments. Participants will be randomly assigned to one of three groups: an immersive skills-based VR therapy that teaches meditation and pain coping techniques, an immersive distraction VR therapy featuring patient-selected videos, or a sham VR group receiving non-immersive 2D video content via VR goggles. All participants will use the Pico G2 4K standalone VR headset daily for four weeks. Additionally, patients will wear a Fitbit to monitor their step counts and sleep patterns. The study will follow participants for 60 days to assess changes. During the study, participants will complete weekly questionnaires sent by email to report on pain, physical and mental health, and social isolation. Researchers will collect data on opioid use, daily pain intensity, and patient satisfaction with pain treatment. The primary outcome is gastrointestinal belly pain measured by the NIH PROMIS questionnaire over 30 days. Secondary outcomes include continued pain assessment, physical activity, and opioid use over 60 days. The goal is to develop a model to predict who benefits most from VR therapy for cancer pain.
CONDITIONS
Brief Title
Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin are eligible
- Have clinically significant visceral pain measured as at least 5 points above the national average on the NIH PROMIS GI Pain Scale
- Ability to read and write in English
You will not qualify if you...
- Have a condition interfering with VR use, such as seizures, facial injury preventing safe headset placement, or visual impairments
- Have cognitive impairment affecting study participation as assessed during screening
- Have brain metastases
- Have a prognosis of less than 3 months from enrollment as determined by treating oncologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants use VR headsets daily for four weeks to receive immersive skills-based VR therapy, immersive distraction VR therapy, or non-immersive sham VR. They also wear a Fitbit watch to monitor step counts and sleep, and complete weekly questionnaires sent via email.
Weekly questionnaire visits via email
Duration - Up to 8 weeks after treatment
Participants continue to be monitored for outcomes including gastrointestinal belly pain, physical and mental health, opioid use, and pain intensity over a total period of up to 60 days from baseline.
Questionnaire assessments at baseline, week 4, and week 8
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
S
Samuel Eberlein, MSHS
K
Karisma Suchak, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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