Using virtual reality to help manage pain in GI cancer patients
Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
This study is testing if virtual reality can help people with GI cancer manage their severe abdominal pain better than standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04907643 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of therapeutic virtual reality (VR) in managing severe abdominal pain experienced by patients with gastrointestinal (GI) cancer. Participants will be randomized into three groups: one receiving immersive skills-based VR therapy focused on pain management techniques, another using immersive distraction VR to alleviate pain perception, and a control group experiencing non-immersive sham VR. The study aims to assess the impact of these interventions on patient-reported outcomes, including pain levels, activity metrics, and opioid use. By exploring innovative VR modalities, the research seeks to provide a drug-free alternative for pain management in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults with a diagnosis of GI cancer who experience clinically significant visceral pain.
Not a fit: Patients under 18 years of age or those with conditions that interfere with VR usage will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and quality of life for patients suffering from GI cancer.
How similar studies have performed: Previous studies have shown promising results for VR in pain management, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible * 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 * Ability to read and write in English Exclusion Criteria: * Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments * Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible. * Have brain metastases * Have a prognosis of \<3 months from the time of enrollment per treating oncologist
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Brennan Spiegel, MD, MSHS — Cedars-Sinai Medical Center
- Study coordinator: Samuel Eberlein, MSHS
- Email: samuel.eberlein@cshs.org
- Phone: 3104236721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.