RECRUITING

Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes

Conditions

Cancer 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 IIVirtual RealityVRsupportGI cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-05
Study Completion:2026-02-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04907643

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible
  3. * 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
  4. * Ability to read and write in English
  1. * Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments
  2. * 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.
  3. * Have brain metastases
  4. * Have a prognosis of \<3 months from the time of enrollment per treating oncologist

Contacts and Locations

Study Contact

Antwon Chaplin
CONTACT
3102486790
antwon.chaplin@cshs.org
Karisma Suchak, MD
CONTACT
3104230714
karisma.suchak@cshs.org

Principal Investigator

Brennan Spiegel, MD, MSHS
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Scott Irwin, MD, PhD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Brennan Spiegel, MD, MSHS, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center
  • Scott Irwin, MD, PhD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

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 Registration Dates

Study Start Date2021-10-05
Study Completion Date2026-02-16

Study Record Updates

Study Start Date2021-10-05
Study Completion Date2026-02-16

Terms related to this study

Keywords Provided by Researchers

  • Virtual Reality
  • VR
  • support
  • GI cancer
  • cancer pain

Additional Relevant MeSH Terms

  • 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