Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

June 6, 2023 updated by: Brennan Spiegel, Cedars-Sinai Medical Center

Randomized Controlled Trial of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Program A
This arm will include software that provides immersive skills-based content for pain reduction.
Device: 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.
Experimental: Virtual Reality Program B
This arm will include software that provides immersive distraction based content for pain reduction.
Device: 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.
Sham Comparator: Virtual Reality Program C
This arm will include software that provides nonimmersive distraction based content for pain reduction.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Over 30 days from the baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Over 60 days
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).
At baseline, week of Day 30, and week of Day 60
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)
Over 60 days
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.
In a 60-day period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Over 60 days
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).
Over 60 days
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)
Over 60 days
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).
Over 60 days
Steps taken per day
Time Frame: Continuous for 60 days
Steps taken per day over time as measured by Fitbit smartwatch.
Continuous for 60 days
Minutes of sleep over time
Time Frame: Continuous for 60 days
Minutes of sleep over time as measured by Fitbit smartwatch.
Continuous for 60 days
Pain coping skills survey
Time Frame: Day 60
Assessment of pain coping skills over time as measured by a custom pain coping skills survey.
Day 60
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).
Over 60 days
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
Continuous for 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Brennan Spiegel, MD, MSHS, Cedars-Sinai Medical Center
  • Principal Investigator: Scott Irwin, MD, PhD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001363
  • R01CA252211 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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