NCT04907643

Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

StatusRecruiting

PhaseNot applicable

SponsorCedars-Sinai Medical Center

Primary completionMar 31, 2027 (estimated)

At risk: Primary completion moved at least 2 months later.

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Record History

All 15 versions: 11 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Nov 9, 2026 Eligibility criteria expanded, about 8 words
- Primary completion pushed from Jan 1, 2027 to Mar 31, 2027
- Study completion pushed from Mar 16, 2027 to Apr 16, 2027
- Secondary endpoints: details revised at 1 of 4 entries
Notable Feb 18, 2026 Primary completion date: Apr 1, 2026 to Jan 1, 2027
- Study completion date: Jun 16, 2026 to Mar 16, 2027
v14
Minor Oct 29, 2025 Primary completion date: Jan 16, 2026 to Apr 1, 2026
- Study completion date: Feb 16, 2026 to Jun 16, 2026
- Collaborators: 1 to 2
v13
Notable Oct 29, 2024 Primary completion date: Jun 2025 to Jan 16, 2026
- Study completion date: Mar 2026 to Feb 16, 2026
v12
Notable Jun 6, 2023 Phase: Phase 2 to Not applicablev10

Show 5 earlier versionsHide 5 earlier versions

Notable Jan 10, 2023 Eligibility criteria shortened, about 7 words
- Study description shortened, about 22 words
- Site contact updated
v8
Notable Aug 9, 2022 Eligibility criteria shortened, about 1 wordv7
Notable Jul 18, 2022 Eligibility criteria shortened, about 2 words
- Study description expanded, about 18 words
- Collaborators expanded, about 4 words
v6
Notable Jan 10, 2022 Phase: Not applicable to Phase 2
- Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Oct 2021 to Oct 5, 2021
- Site details revised
v4
Minor Aug 11, 2021 Site contact updatedv3

May 26, 2021 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain over 30 days from the baseline

Timeframe: Over 30 days from the baseline

Secondary (4)

Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain

Daily pain intensity

Patient-Reported Outcomes Measurement Information System Global physical and mental health

Opioid prescriptions of Morphine Milligram Equivalents (MME)

Arms and interventions

Virtual Reality Program AExperimental

This arm will include software that provides immersive skills-based content for pain reduction.

Virtual Reality Program BExperimental

This arm will include software that provides immersive distraction based content for pain reduction.

Virtual Reality Program CSham comparator

This arm will include software that provides nonimmersive distraction based content for pain reduction.

Devices: PICO G2 4k

Sites

1 site in 1 country

Cedars-Sinai Medical CenterLos Angeles, California, United States

About this trial

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.

Trial details

Enrollment: 360 participants (estimated)
Started: Oct 5, 2021
Study completion: Apr 16, 2027 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, triple blind, supportive care
Oversight: Data monitoring committee, FDA-regulated device
Conditions: Anus Neoplasms, Appendiceal Neoplasms, Bile Duct Neoplasms, Biliary Tract Neoplasms, Cancer Pain, Carcinoid Tumor, Colonic Neoplasms, Esophageal Neoplasms +85 more
Collaborators: National Cancer Institute (NCI), University of California, Los Angeles
Official title: Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
First posted: Jun 1, 2021
Registry updated: Nov 12, 2026
Last verified: Feb 2026

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