Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

NCT04907643 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY00001363R01CA252211
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Gastrointestinal Cancers - Small Intestine; 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 Stage III; Ampullary Cancer; Bile Duct Cancer; Bile Duct Cancer Stage III; Bile Duct Cancer Stage IVA; Bile Duct Cancer Stage IVB; Bile Duct Cancer Recurrent; Carcinoid Tumor of Pancreas; Esophagus Cancer, Stage II; Gallbladder Cancer Stage I; Gallbladder Cancer Stage II; Bile Duct Cancer Stage I; Bile Duct Cancer Stage II; 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; Small Intestine Cancer Stage III; Small Intestine Cancer Stage IV; Anal Cancer; Anal Cancer Stage IV; Anal Cancer Recurrent; Anal Cancer Metastatic; Anal Cancer, Stage IIIA; Anal Cancer, Stage IIIB; Appendix Cancer; Bile Duct Cancer Stage IV; Carcinoid Tumor; 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

Keywords

Virtual Reality; VR; support; GI cancer; cancer pain

Outcome Measures

Primary Outcomes (1)

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

  Gastrointestinal Belly Pain over time as measured by Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain 5a delivered on a weekly basis (T-Scored, Continuous, 1-5, higher the worse).

  Over 30 days from the baseline

Secondary Outcomes (4)

• Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain

  Over 60 days

• Daily pain intensity

  At baseline, week of Day 30, and week of Day 60

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

  Over 60 days

• Opioid prescriptions of Morphine Milligram Equivalents (MME)

  In a 60-day period

Other Outcomes (9)

• Patient-Reported Outcomes Measurement Information System Pain Interference 4a

  Over 60 days

• Patient Global Impression of Change

  Over 60 days

• Patient-Reported Outcomes Measurement Information System Social Isolation

  Over 60 days

Study Arms (3)

Virtual Reality Program A

EXPERIMENTAL

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

Device: PICO G2 4k

Virtual Reality Program B

EXPERIMENTAL

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

Device: PICO G2 4k

Virtual Reality Program C

SHAM COMPARATOR

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

Device: PICO G2 4k

Interventions

PICO G2 4k DEVICE

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.

Virtual Reality Program A; Virtual Reality Program B; Virtual Reality Program C

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Cancer Institute (NCI): collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Links

• Study web portal for more information and a self-assessment for eligibility

MeSH Terms

Conditions

Cancer Pain; Visceral Pain; Gastrointestinal Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Colonic Neoplasms; Biliary Tract Neoplasms; Stomach Neoplasms; Rectal Neoplasms; Recurrence; Neoplasm Metastasis; Anus Neoplasms; Appendiceal Neoplasms; Bile Duct Neoplasms; Carcinoid Tumor; Esophageal Neoplasms; Gallbladder Neoplasms; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nociceptive Pain; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Biliary Tract Diseases; Stomach Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Neoplastic Processes; Anus Diseases; Cecal Neoplasms; Cecal Diseases; Bile Duct Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Head and Neck Neoplasms; Esophageal Diseases; Gallbladder Diseases

Study Officials

• Brennan Spiegel, MD, MSHS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Scott Irwin, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Eberlein, MSHS

CONTACT

3104236721; samuel.eberlein@cshs.org

Karisma Suchak, MD

CONTACT

3104230714; karisma.suchak@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Health Services Research

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: June 1, 2021
• Study Start: October 5, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 16, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)