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Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

ConditionsCancer PainVisceral PainGastrointestinal NeoplasmsCancer of Gastrointestinal TractSmall Intestine CancerPancreas CancerLiver CancerColon CancerBiliary Tract CancerStomach CancerRectum CancerPeritoneal CancerGastrointestinal Cancer MetastaticGastrointestinal Cancers - AnusGastrointestinal Cancers - StomachGastrointestinal Cancers - ColorectalGastrointestinal Cancers - Small IntestineSmall Intestine Cancer Stage IIISmall Intestine Cancer Stage IVSmall Intestine Cancer, RecurrentPancreas Cancer, Stage IIIPancreas Cancer, Stage IVPancreas Cancer, MetastaticPancreas Cancer, RecurrentLiver Cancer Stage IIIaLiver Cancer Stage IIIbLiver Cancer Stage IIIcLiver Cancer Stage IVColon Cancer Stage IIIColon Cancer Stage IVStomach Cancer Stage IIIStomach Cancer Stage IVStomach Cancer RecurrentRectum Cancer, RecurrentGastrointestinal Cancers - LiverAnal CancerAnal Cancer Stage IIIAnal Cancer Stage IVAnal Cancer RecurrentAnal Cancer MetastaticAnal Cancer, Stage IIIAAnal Cancer, Stage IIIBAppendix CancerAmpullary CancerBile Duct CancerBile Duct Cancer Stage IIIBile Duct Cancer Stage IVBile Duct Cancer Stage IVABile Duct Cancer Stage IVBBile Duct Cancer RecurrentCarcinoid TumorCarcinoid Tumor of PancreasCarcinoid Tumor of Large IntestineCarcinoid Tumor of GI SystemCarcinoid Tumor of ColonCarcinoid Tumor of LiverCarcinoid Tumor of CecumCarcinoid Tumor of IleumCarcinoid Tumor of RectumCarcinoid Tumor of the Small BowelCarcinoid Tumor of the StomachLarge Intestine CancerEsophagus CancerEsophagus Cancer, Stage IIIEsophagus Cancer, Stage IVEsophagus Cancer, RecurrentGallbladder CancerGallbladder Cancer Stage IIIGallbladder Cancer Stage IVGastric (Stomach) CancerNeuroendocrine TumorPeritoneum CancerRectal CancerEsophagus Cancer, Stage IEsophagus Cancer, Stage IIGallbladder Cancer Stage IGallbladder Cancer Stage IIBile Duct Cancer Stage IBile Duct Cancer Stage II
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorCedars-Sinai Medical Center

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

360 Participants
are divided into 3 treatment groups
Group A: Virtual Reality Program AExperimental treatment 1 intervention
Group B: Virtual Reality Program BExperimental treatment 1 intervention
Group C: Virtual Reality Program CSham comparator 1 intervention

Trial outcomes

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).

Time frame
Over 30 days from the baseline

Secondary outcomes

1

Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain

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).

Time frame
Over 60 days
2

Daily pain intensity

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).

Time frame
At baseline, week of Day 30, and week of Day 60
3

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

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)

Time frame
Over 60 days
4

Opioid prescriptions of Morphine Milligram Equivalents (MME)

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

Time frame
In a 60-day period

Other outcomes

1

Patient-Reported Outcomes Measurement Information System Pain Interference 4a

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).

Time frame
Over 60 days
2

Patient Global Impression of Change

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).

Time frame
Over 60 days
3

Patient-Reported Outcomes Measurement Information System Social Isolation

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)

Time frame
Over 60 days
4

Pain Catastrophizing scale 4 item short form.

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).

Time frame
Over 60 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

University of California, Los Angeles

Collaborator

Source ClinicalTrials.gov
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