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NCT Number: NCT04907643

Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

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.

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Key information

Conditions

Cancer Pain Adenocarcinoma Ampullary Cancer Anal Cancer Anal Cancer Metastatic Anal Cancer Recurrent Anal Cancer Stage III Anal Cancer Stage IV Anal Cancer, Stage IIIA Anal Cancer, Stage IIIB Anus Diseases Anus Neoplasms Appendiceal Neoplasms Appendix Cancer Bile Duct Cancer Bile Duct Cancer Recurrent Bile Duct Cancer Stage I Bile Duct Cancer Stage II Bile Duct Cancer Stage III Bile Duct Cancer Stage IV Bile Duct Cancer Stage IVA Bile Duct Cancer Stage IVB Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Cancer of Gastrointestinal Tract Carcinoid Tumor Carcinoid Tumor of Cecum Carcinoid Tumor of Colon Carcinoid Tumor of GI System Carcinoid Tumor of Ileum Carcinoid Tumor of Large Intestine Carcinoid Tumor of Liver Carcinoid Tumor of Pancreas Carcinoid Tumor of Rectum Carcinoid Tumor of the Small Bowel Carcinoid Tumor of the Stomach Carcinoma Cecal Diseases Cecal Neoplasms Colon Cancer Colon Cancer Stage III Colon Cancer Stage IV Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Esophagus Cancer Esophagus Cancer, Recurrent Esophagus Cancer, Stage I Esophagus Cancer, Stage II Esophagus Cancer, Stage III Esophagus Cancer, Stage IV Gallbladder Cancer Gallbladder Cancer Stage I Gallbladder Cancer Stage II Gallbladder Cancer Stage III Gallbladder Cancer Stage IV Gallbladder Diseases Gallbladder Neoplasms Gastric (Stomach) Cancer Gastrointestinal Cancer Metastatic Gastrointestinal Cancers - Anus Gastrointestinal Cancers - Colorectal Gastrointestinal Cancers - Liver Gastrointestinal Cancers - Small Intestine Gastrointestinal Cancers - Stomach Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Large Intestine Cancer Liver Cancer Liver Cancer Stage IIIa Liver Cancer Stage IIIb Liver Cancer Stage IIIc Liver Cancer Stage IV Liver Diseases Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumor Neuroendocrine Tumors Neurologic Manifestations Nociceptive Pain Pain Pancreas Cancer Pancreas Cancer, Metastatic Pancreas Cancer, Recurrent Pancreas Cancer, Stage III Pancreas Cancer, Stage IV Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Cancer Peritoneum Cancer Rectal Cancer Rectal Diseases Rectal Neoplasms Rectum Cancer Rectum Cancer, Recurrent Recurrence Signs and Symptoms Small Intestine Cancer Small Intestine Cancer Stage III Small Intestine Cancer Stage IV Small Intestine Cancer, Recurrent Stomach Cancer Stomach Cancer Recurrent Stomach Cancer Stage III Stomach Cancer Stage IV Stomach Diseases Stomach Neoplasms Visceral Pain

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Karisma Kothari, MD

CONTACT

[email protected]

310-423-0714

About this study

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 therapy, such as opioids. This study will evaluate a novel technology called virtual reality (VR). Users of VR wear a pair of goggles with a three-dimensional screen that creates a sensation of being transported into lifelike worlds. Evidence shows that VR can reduce pain through many different mechanisms. Research shows that VR can also help train people in new skills, such as to meditate, breathe deeply, and learn how to cope with pain.

In this study, patients with GI cancer pain will be randomized into three groups of equal size: (1) immersive skills-based VR therapy; (2) immersive distraction VR therapy; and (3) non-immersive sham VR using 2D videos displayed in a VR headset. The skills-based treatment will use virtual healing environments to teach patients about meditation, breathing exercises, and pain management. The distraction treatment will use immersive videos that are designed to take the mind off of pain. The sham VR will use VR goggles, but patients will only watch a two-dimensional video rather than a 3D, immersive experience.

Eligible patients will have GI cancer pain, meaning belly pain at least 5 points above the national average on the NIH PROMIS GI Scale as well as having a GI cancer diagnosis. . The study will exclude people who are under 18 years of age, unable to understand the consent form, expected to live less than 3 months, brain tumors not responding to treatment, or injury that makes it difficult to wear something on their face.

Randomization between groups will occur using a computer program called REDCap and will be performed after obtaining patient consent for participating in the study. The VR goggles will be shipped via FedEx to patients in all three groups, along with instructions for use. Patients will then be asked to actively use the headset for four weeks on a daily basis, following the specific instructions for their assigned intervention. In addition, patients will wear a Fitbit watch on their wrist during the study, as tolerated, to monitor step counts and sleep. Participants will fill out a set of weekly questionnaires that will be sent via email.

In order to show a difference between the active VR treatments and the sham VR control treatment, the investigator will recruit a minimum of 120 patients in each arm of the study. This calculation is sufficient to demonstrate clinically meaningful differences in the primary outcome, which is Gastrointestinal belly pain levels as measured by the NIH Patient Reported Outcome Measurement Information System, or PROMIS® questionnaire. PROMIS is a well-validated set of questionnaires that measure different aspects of quality of life; for this study the investigator will focus on PROMIS Gastrointestinal belly pain, Global physical and mental health, and Social isolation. Daily pain catastrophizing, Milligram morphine equivalent daily dose, Simulator sickness, Pain treatment satisfaction, Pain self-efficacy (PSEQ), baseline demographic information, Pain Diary, and Pain Behaviors will also be measured. The investigator will compare the number of steps taken per day and sleep levels among the three groups using statistical tests that account for potential difference among the groups. Finally, the investigator will perform statistical analyses to identify whether there are individual patient characteristics that predict response to VR therapy. The goal will be to develop a mathematical algorithm that optimized patient selection to make more precise treatment decisions with VR.

To learn more about the study and to assess your eligibility, please visit our study website at: https://virtualmedicine.org/research/current/gicancer

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain

    Time frame: Over 60 days

    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).

  2. Daily pain intensity

    Time frame: At baseline, week of Day 30, and week of Day 60

    Daily pain intensity for one week at baseline, week of Day 30, and week of Day 60 as measured by Daily Pain Intensity Scale (0-10, where 0 means no pain and 10 means the worst pain imaginable).

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

    Time frame: Over 60 days

    Global physical and mental health over time as measured by Patient-Reported Outcomes Measurement Information System Global Physical and Mental 2a. delivered on a weekly basis (1-5, higher the better)

  4. Opioid prescriptions of Morphine Milligram Equivalents (MME)

    Time frame: In a 60-day period

    Comparing the change from study baseline to Day 60 in weekly MME of prescribed medication.

Other outcomes

  1. Patient-Reported Outcomes Measurement Information System Pain Interference 4a

    Time frame: Over 60 days

    Pain interference over time as measured by Patient-Reported Outcomes Measurement Information System-Pain Interference 4a delivered on a weekly basis (T-Scored, Continuous, 1-5, higher the worse).

  2. Patient Global Impression of Change

    Time frame: Over 60 days

    Patient Global Impression of Change over time as measured by Patient Global Impression of Change Scale delivered on a weekly basis (PGIC, 1-7, higher the worse).

  3. Patient-Reported Outcomes Measurement Information System Social Isolation

    Time frame: Over 60 days

    Social Isolation over time as measured weekly by Patient-Reported Outcomes Measurement Information System Social Isolation short form 4a. delivered on a weekly basis (1-5, higher the worse)

  4. Pain Catastrophizing scale 4 item short form.

    Time frame: Over 60 days

    Pain catastrophizing over time as measured by Pain Catastrophizing scale (PCS) 4 item short form delivered on a weekly basis (0-4, from not at all to all the time, higher the worse).

  5. Steps taken per day

    Time frame: Continuous for 60 days

    Steps taken per day over time as measured by Fitbit smartwatch.

  6. Minutes of sleep over time

    Time frame: Continuous for 60 days

    Minutes of sleep over time as measured by Fitbit smartwatch.

  7. Pain coping skills survey

    Time frame: Day 60

    Assessment of pain coping skills over time as measured by a custom pain coping skills survey.

  8. Pain Self-Efficacy Questionnaire (PSEQ) 2-item short form

    Time frame: Over 60 days

    Pain self-efficacy over time as measured by The Pain Self-Efficacy Questionnaire (PSEQ) 2-item short form delivered on a weekly basis (0-6, higher the better).

  9. Dosage of VR (minutes per week)

    Time frame: Continuous for 60 days

    minutes of use per week will be extracted from the VR device via wifi network

Study contacts

Contact information is provided by the study sponsor or research team.

Karisma Suchak, MD

CONTACT

[email protected]

3104230714

Samuel Eberlein, MSHS

CONTACT

[email protected]

3104236721

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of California, Los Angeles

Registry information

Official study title

Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2021
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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