Clinical trial NCT04907643: Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Official title: Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Gastrointestinal Cancers - Small Intestine
Small Intestine Cancer Stage III
Small Intestine Cancer Stage IV
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
Anal Cancer Stage III
Anal Cancer Stage IV
Anal Cancer Recurrent
Anal Cancer Metastatic
Anal Cancer, Stage IIIA
Anal Cancer, Stage IIIB
Appendix Cancer
Ampullary Cancer
Bile Duct Cancer
Bile Duct Cancer Stage III
Bile Duct Cancer Stage IV
Bile Duct Cancer Stage IVA
Bile Duct Cancer Stage IVB
Bile Duct Cancer Recurrent
Carcinoid Tumor
Carcinoid Tumor of Pancreas
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
Esophagus Cancer, Stage II
Gallbladder Cancer Stage I
Gallbladder Cancer Stage II
Bile Duct Cancer Stage I
Bile Duct Cancer Stage II
Keywords: Virtual Reality
VR
support
GI cancer
cancer pain
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-06-01
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain over 30 days from the baseline
timeFrame: Over 30 days from the baseline
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain
timeFrame: Over 60 days
measure: Daily pain intensity
timeFrame: At baseline, week of Day 30, and week of Day 60
measure: Patient-Reported Outcomes Measurement Information System Global physical and mental health
timeFrame: Over 60 days
measure: Opioid prescriptions of Morphine Milligram Equivalents (MME)
timeFrame: In a 60-day period
Other outcomes:
measure: Patient-Reported Outcomes Measurement Information System Pain Interference 4a
timeFrame: Over 60 days
measure: Patient Global Impression of Change
timeFrame: Over 60 days
measure: Patient-Reported Outcomes Measurement Information System Social Isolation
timeFrame: Over 60 days
measure: Pain Catastrophizing scale 4 item short form.
timeFrame: Over 60 days
measure: Steps taken per day
timeFrame: Continuous for 60 days
measure: Minutes of sleep over time
timeFrame: Continuous for 60 days
measure: Pain coping skills survey
timeFrame: Day 60
measure: Pain Self-Efficacy Questionnaire (PSEQ) 2-item short form
timeFrame: Over 60 days
measure: Dosage of VR (minutes per week)
timeFrame: Continuous for 60 days
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Brennan Spiegel, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Scott Irwin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: