Using virtual reality to help manage pain in GI cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.