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Virtual Reality Therapy for Gastrointestinal Cancer Pain

N/A
Recruiting
Led By Brennan Spiegel, MD, MSHS
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Must not have
Have brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, week of day 30, and week of day 60

Summary

This trial will assess the impact of immersive VR on pain and other patient-reported outcomes for people with digestive tract malignancies, as well as differences between skills-based VR therapy and distraction VR therapy.

Who is the study for?
This trial is for adults with certain types of digestive tract cancers (like colon, liver, or stomach cancer) who are not planning surgery soon and have significant pain. They must be able to read/write in English and score high on a specific pain scale. People can't join if they have seizures, severe visual impairments, cognitive issues that affect understanding the study, brain metastases, or a life expectancy less than 3 months.
What is being tested?
The trial tests how virtual reality (VR) affects patient-reported outcomes like pain levels and opioid use in patients with visceral cancer pain. It compares three groups: one using VR with skills training; another using VR for distraction; and a control group watching 2-D content on VR headsets.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort from wearing the headset, dizziness or motion sickness from VR usage. However, these side effects are generally mild.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is in the digestive system and surgery isn't planned.
Select...
I experience significant stomach pain, scoring 5 points above the average on a pain scale.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, week of day 30, and week of day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, week of day 30, and week of day 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain over 30 days from the baseline
Secondary study objectives
Daily pain intensity
Opioid prescriptions of Morphine Milligram Equivalents (MME)
Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain
+1 more
Other study objectives
Dosage of VR (minutes per week)
Minutes of sleep over time
Pain Catastrophizing scale 4 item short form.
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Virtual Reality Program BExperimental Treatment1 Intervention
This arm will include software that provides immersive distraction based content for pain reduction.
Group II: Virtual Reality Program AExperimental Treatment1 Intervention
This arm will include software that provides immersive skills-based content for pain reduction.
Group III: Virtual Reality Program CPlacebo Group1 Intervention
This arm will include software that provides nonimmersive distraction based content for pain reduction.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PICO G2 4k
2020
N/A
~390

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
512 Previous Clinical Trials
163,004 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,779 Total Patients Enrolled
Brennan Spiegel, MD, MSHSPrincipal InvestigatorCedars-Sinai Medical Center
8 Previous Clinical Trials
1,782 Total Patients Enrolled

Media Library

Virtual Reality Clinical Trial Eligibility Overview. Trial Name: NCT04907643 — N/A
Gastrointestinal Tumors Research Study Groups: Virtual Reality Program C, Virtual Reality Program B, Virtual Reality Program A
Gastrointestinal Tumors Clinical Trial 2023: Virtual Reality Highlights & Side Effects. Trial Name: NCT04907643 — N/A
Virtual Reality 2023 Treatment Timeline for Medical Study. Trial Name: NCT04907643 — N/A
~92 spots leftby Jan 2026
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