A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)

To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Pediatric ALL
• Intervention / Treatment: Other: IPAD; Other: Augmented Reality

Detailed Description

Primary Objective:

•To assess the efficacy of SpellBound's AR-enabled scavenger hunt to reduce the rate of 90-day opioid use in pediatric cancer patients undergoing surgery compared to a control non-AR game in a randomized controlled trial.

Secondary Objectives:

To assess the effect of AR versus non-AR control technology in pediatric oncology patients, including:

• Inpatient opioid use
• Average daily inpatient pain score
• Number of opioid requests during the hospital stay
• Inpatient PedsQL (quality of life) questionnaire score
• Ambulation/"out of bed" movement
• Number days to discharge-ready status
• Patient experience assessed by satisfaction scores on a questionnaire designed by MD Anderson Cancer Center Child Life team.
• Outpatient opioid consumption reported at 30, 60, and 90 days
• Outpatient pain scores reported at 30, 60, and 90 days
• Outpatient PedsQL scores reported at 30, 60, and 90 days
• Potential adverse events related to the use of AR (i.e., falls).

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Juan Cata, MD; Phone Number: (713) 792-7452; Email: jcata@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Principal Investigator: Juan Cata, MD
      • Contact: Juan Cata, MD; Phone Number: 713-792-7452; Email: jcata@mdanderson.org
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Children's Hospital
      • Contact: Clinton Fuller, MD; Phone Number: 832-824-8584; Email: Clinton.fuller@bcm.edu
      • Principal Investigator: Clinton Fuller, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ages 5-15
2. English and Spanish-speaking parents/legal guardians and patients
3. Undergoing major surgery for cancer requiring postoperative hospitalization is defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night
4. Expected to be prescribed postoperative inpatient opioids
5. Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
6. Sufficient cognitive capacity to comprehend and interact with the game. This is defined as the ability to utilize mobile technology (use iPad with or without assistance) and activate and respond to AR experiences within the app as determined by the clinician.

7. Both the child and a legal guardian are willing and able to provide informed consent.

   • The range from 5-to 15 is based on a recent pilot RCT in which the PI found that older adolescents (>15 years of age) were disinterested in the interactive game.

Exclusion Criteria:

1. Patients with any daily opioid use within 30 days before surgery.
2. History of documented peripheral neuropathy secondary to cancer treatment
3. Inability to demonstrate an understanding of the game from English instructions
4. Any additional concerns based on the study physicians' assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1(Spellbound); Participants will play the game using the iPad's standard camera, which will show you your hospital room and the decals as they appear in the real world.	Other: IPAD; Participant will play a game through (standard camera) participants will be able to the hospital room and decals as they appear in the real world
Other: Group 2 (Spellbound); Participants will play the game using augmented reality	Other: Augmented Reality; Participants will play a game through (devices camera and application) let us participants view the real world

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Quality of Life Inventory Questionnaires	Quality of life assessment-Age-appropriate Pediatric Quality of Life Inventory (PedsQL)29 paper surveys will be administered to the patient (self-report) or guardian (proxy) when patients reach discharge-ready status. Score scales (0-4) 0-Never/4 Almost Always	through completion of study, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Juan Cata, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-0336; NCI-2022-05979 (Other Identifier: NCI-CTRP Clinical Trials Reporting Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No