Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Public ClinicalTrials.gov record NCT04907643. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain. To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.
Study identification
- NCT ID
- NCT04907643
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 360 participants
Conditions and interventions
Conditions
- Cancer Pain
- Visceral Pain
- Gastrointestinal Neoplasms
- Cancer of Gastrointestinal Tract
- Small Intestine Cancer
- Pancreas Cancer
- Liver Cancer
- Colon Cancer
- Biliary Tract Cancer
- Stomach Cancer
- Rectum Cancer
- Peritoneal Cancer
- Gastrointestinal Cancer Metastatic
- Gastrointestinal Cancers - Anus
- Gastrointestinal Cancers - Stomach
- Gastrointestinal Cancers - Colorectal
- Gastrointestinal Cancers - Small Intestine
- Small Intestine Cancer Stage III
- Small Intestine Cancer Stage IV
- Small Intestine Cancer, Recurrent
- Pancreas Cancer, Stage III
- Pancreas Cancer, Stage IV
- Pancreas Cancer, Metastatic
- Pancreas Cancer, Recurrent
- Liver Cancer Stage IIIa
- Liver Cancer Stage IIIb
- Liver Cancer Stage IIIc
- Liver Cancer Stage IV
- Colon Cancer Stage III
- Colon Cancer Stage IV
- Stomach Cancer Stage III
- Stomach Cancer Stage IV
- Stomach Cancer Recurrent
- Rectum Cancer, Recurrent
- Gastrointestinal Cancers - Liver
- Anal Cancer
- Anal Cancer Stage III
- Anal Cancer Stage IV
- Anal Cancer Recurrent
- Anal Cancer Metastatic
- Anal Cancer, Stage IIIA
- Anal Cancer, Stage IIIB
- Appendix Cancer
- Ampullary Cancer
- Bile Duct Cancer
- Bile Duct Cancer Stage III
- Bile Duct Cancer Stage IV
- Bile Duct Cancer Stage IVA
- Bile Duct Cancer Stage IVB
- Bile Duct Cancer Recurrent
- Carcinoid Tumor
- Carcinoid Tumor of Pancreas
- Carcinoid Tumor of Large Intestine
- Carcinoid Tumor of GI System
- Carcinoid Tumor of Colon
- Carcinoid Tumor of Liver
- Carcinoid Tumor of Cecum
- Carcinoid Tumor of Ileum
- Carcinoid Tumor of Rectum
- Carcinoid Tumor of the Small Bowel
- Carcinoid Tumor of the Stomach
- Large Intestine Cancer
- Esophagus Cancer
- Esophagus Cancer, Stage III
- Esophagus Cancer, Stage IV
- Esophagus Cancer, Recurrent
- Gallbladder Cancer
- Gallbladder Cancer Stage III
- Gallbladder Cancer Stage IV
- Gastric (Stomach) Cancer
- Neuroendocrine Tumor
- Peritoneum Cancer
- Rectal Cancer
- Esophagus Cancer, Stage I
- Esophagus Cancer, Stage II
- Gallbladder Cancer Stage I
- Gallbladder Cancer Stage II
- Bile Duct Cancer Stage I
- Bile Duct Cancer Stage II
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 4, 2021
- Primary completion
- Dec 31, 2026
- Completion
- Mar 15, 2027
- Last update posted
- Feb 19, 2026
2021 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04907643, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 19, 2026 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04907643 live on ClinicalTrials.gov.