PICO G2 4k for Gallbladder Cancer Stage II

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Gallbladder Cancer Stage II+79 MorePICO G2 4k - Device
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess the impact of immersive VR on pain and other patient-reported outcomes for people with digestive tract malignancies, as well as differences between skills-based VR therapy and distraction VR therapy.

Eligible Conditions
  • Gallbladder Cancer Stage II
  • Carcinoid Tumor
  • Esophageal Cancer, Recurrent
  • Cancer Pain
  • Metastatic Gastrointestinal Cancer
  • Anal Cancer
  • Rectal Cancer, Recurrent
  • Carcinoid Tumor of the Rectum
  • Neuroendocrine Tumors
  • Esophageal Cancer, Stage II
  • Liver Cancer
  • Small Intestinal Cancer
  • Pancreatic Cancer, Stage III
  • Metastatic Pancreatic Cancer
  • Esophageal Cancer, Stage IV
  • Stomach Cancer Recurrence
  • Gastric Cancer
  • Biliary Tract Cancer
  • Stomach Cancer
  • Carcinoid Tumor of the Pancreas
  • Bile Duct Cancer Stage IVB
  • Carcinoid Tumor of Liver
  • Colorectal Cancer
  • Gallbladder Cancer Stage I
  • Bile Duct Cancer Stage II
  • Stomach Cancer Stage III
  • Pancreatic Cancer
  • Malignant Peritoneal Neoplasm
  • Esophageal Cancer, Stage III
  • Gallbladder Cancer Stage IV
  • Pancreatic Cancer, Stage IV
  • Bile Duct Cancer Recurrent
  • Carcinoid Tumor of the Large Intestine
  • Carcinoid Tumor of the Cecum
  • Bile Duct Cancer Stage I
  • Gallbladder Cancer
  • Peritoneal Cancer
  • Bile Duct Cancer Stage IVA
  • Visceral Pain
  • Small Intestine Cancer Stage III
  • Anal Cancer Stage III
  • Esophageal Cancer
  • Esophageal Cancer, Stage I
  • Gastrointestinal Tumors
  • Pancreas Cancer, Recurrent
  • Carcinoid Tumor of Colon
  • Gallbladder Cancer Stage III
  • Anal Cancer Stage IV
  • Anal Cancer Recurrent
  • Anal Cancer Metastasis
  • Anal Cancer, Stage IIIA
  • Anal Cancer, Stage IIIB
  • Appendiceal Cancer
  • Ampullary Cancer
  • Cholangiocarcinoma
  • Bile Duct Cancer Stage III
  • Advanced Bile Duct Cancer
  • Gastrointestinal Cancer
  • Small Intestine Cancer
  • Colon Cancer
  • Small Intestine Cancer Stage IV
  • Recurrent Small Intestine Cancer
  • Liver Cancer Stage IIIa
  • Liver Cancer Stage IIIb
  • Liver Cancer Stage IIIc
  • Advanced Liver Cancer
  • Stage III Colon Cancer
  • Colon Cancer Stage IV
  • Stomach Cancer Stage IV

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: At baseline, week of Day 30, and week of Day 60

Day 60
Daily pain intensity
Continuous for 60 days
Dosage of VR (minutes per week)
Minutes of sleep over time
Steps taken per day
Day 60
Pain coping skills survey
In a 60-day period
Opioid prescriptions of Morphine Milligram Equivalents (MME)
Day 30
Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain over 30 days from the baseline
Over 60 days
Pain Catastrophizing scale 4 item short form.
Pain
Patient Global Impression of Change
Patient-Reported Outcomes Measurement Information System Gastrointestinal Belly Pain
Patient-Reported Outcomes Measurement Information System Global physical and mental health
Pain
Patient-Reported Outcomes Measurement Information System Social Isolation

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Trial Design

3 Treatment Groups

Virtual Reality Program B
1 of 3
Virtual Reality Program A
1 of 3
Virtual Reality Program C
1 of 3

Experimental Treatment

Non-Treatment Group

360 Total Participants · 3 Treatment Groups

Primary Treatment: PICO G2 4k · Has Placebo Group · Phase 2

Virtual Reality Program B
Device
Experimental Group · 1 Intervention: PICO G2 4k · Intervention Types: Device
Virtual Reality Program A
Device
Experimental Group · 1 Intervention: PICO G2 4k · Intervention Types: Device
Virtual Reality Program C
Device
ShamComparator Group · 1 Intervention: PICO G2 4k · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline, week of day 30, and week of day 60

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
457 Previous Clinical Trials
154,045 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,084 Previous Clinical Trials
41,141,286 Total Patients Enrolled
Scott Irwin, MD, PhDPrincipal InvestigatorCedars-Sinai Medical Center
3 Previous Clinical Trials
24 Total Patients Enrolled
Brennan Spiegel, MD, MSHSPrincipal InvestigatorCedars-Sinai Medical Center
8 Previous Clinical Trials
1,782 Total Patients Enrolled

Eligibility Criteria

Age 18 - 99 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Tumor types eligible for inclusion include adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin.
You experience clinically significant visceral pain, as indicated by a score of five or more points above the nationally-recognized standard on the NIH PROMIS GI Pain Scale.
You possess the capacity to read and write in English.
You have a primary malignant condition of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine or stomach without any intent to undergo resection during the research period.