Status:
RECRUITING
Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
University of California, Los Angeles
Conditions:
Cancer Pain
Visceral Pain
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of l...
Detailed Description
GI cancer pain is a prevalent and costly condition. Medical therapy is not always effective for managing GI cancer pain; there is a need for drug-free alternative to complement or even replace medical...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 16 2026
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04907643
Start Date
October 5 2021
End Date
June 16 2026
Last Update
October 30 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048