Recruiting

Virtual Reality

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT04907643

Conditions

Cancer Pain

Visceral Pain

Gastrointestinal Neoplasms

Cancer of Gastrointestinal Tract

Small Intestine Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PICO G2 4k

Study Details

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 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.

Conditions

Cancer Pain

Visceral Pain

Gastrointestinal Neoplasms

Cancer of Gastrointestinal Tract

Small Intestine Cancer

Study ID

NCT04907643

Start date

Oct 5, 2021

Status verified date

Feb, 2026

Completion date

Mar 16, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Virtual Reality Program A

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

experimental: Virtual Reality Program B

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

sham comparator: Virtual Reality Program C

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

Interventions

PICO G2 4k

Participants will use the Pico G2 4K VR audio and visual head-mounted device. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.

Primary outcome measure

  • Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain over 30 days from the baseline [ Time Frame: Over 30 days from the baseline ]

Central Contacts and Locations

Central contacts

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • Virtual Reality
  • VR
  • support
  • GI cancer
  • cancer pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-02-20.