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Virtual Reality Therapy for Gastrointestinal Cancer Pain

N/A
Recruiting
Led By Scott Irwin, MD, PhD
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
Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, week of day 30, and week of day 60
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 type is one of the following: adenocarcinoma, squamous cell, neuroendocrine, or mesenchymal.
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain over 30 days from the baseline
Secondary outcome measures
Daily pain intensity
Opioid prescriptions of Morphine Milligram Equivalents (MME)
Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain
+1 more
Other outcome measures
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
497 Previous Clinical Trials
164,199 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,987 Total Patients Enrolled
Scott Irwin, MD, PhDPrincipal InvestigatorCedars-Sinai Medical Center
3 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

Virtual Reality Clinical Trial Eligibility Overview. Trial Name: NCT04907643 — N/A
Gallbladder Cancer Research Study Groups: Virtual Reality Program A, Virtual Reality Program B, Virtual Reality Program C
Gallbladder Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment extend to individuals who are 45 years or older?

"This medical study is seeking out individuals aged 18 or higher and below 99 years old."

Answered by AI

Is enrollment available for this experiment?

"As per current information posted on clinicaltrials.gov, this research project is still accepting participants. The trial was originally published on October 5th 2021 and has since undergone one revision, occurring August 9th 2022."

Answered by AI

Has the FDA acknowledged PICO G2 4k as a certified medical device?

"Though there is preliminary evidence of safety, no clinical data confirms efficacy so our team has ranked PICO G2 4k with a score of 2."

Answered by AI

To whom does the eligibility criteria for this trial apply?

"To be accepted into this clinical study, applicants should have a diagnosis of gallbladder cancer and must lie between 18-99 years old. A total of 360 patients need to be enrolled in the trial."

Answered by AI

How many people are partaking in this experimental research?

"Affirmative. Per the information hosted on clinicaltrials.gov, this trial is actively accruing patients and was first made available on October 5th 2021. The study has a target of 360 participants that need to be enrolled at a single medical centre before it can begin."

Answered by AI
~117 spots leftby Jun 2025