A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Tolerant Users Undergoing Surgery to Reduce Post-operative Opioid Use

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

Study Overview

• Status: Withdrawn
• Conditions: Cancer
• Intervention / Treatment: Device: IPAD; Device: Augmented Reality

Detailed Description

Primary Objective:

To assess the efficacy of SpellBound's AR-enabled scavenger hunt to reduce the rate of additional inpatient opioid use in pediatric cancer patients who are chronic/tolerant opioid users undergoing surgery compared to a control non-AR game in a randomized controlled trial.

Secondary Objectives:

To assess the impact 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 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 questionnaire designed by MD Anderson Cancer Center Child Life team
• Outpatient opioid use reported at 30, 60, 90 days.
• Outpatient pain scores reported at 30, 60, 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
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 11 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 surgery 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. Prescribed daily opioids for pain for a period equal to or longer than 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. Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
2. Inability to demonstrate an understanding of the game from English instructions
3. Any additional concerns based on the study physicians' assessments b. Setting: Academic tertiary cancer center: University of Texas - MD Anderson Cancer Center and Baylor College of Medicine - Texas Children's Hospital

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
Experimental: Group 1 (Spellbound); Participants will play SpellBound using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world.	Device: IPAD; Participants will play a game using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world.
Experimental: Group 2 (Spellbound); Participants will play the game using augmented reality.	Device: Augmented Reality; Participants will play a game through (device camera and application) that add virtual or digital characters and items that let participants view the real world.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Quality of Life Inventory	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.	through completion of study, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Juan Cata, MD, MD Anderson

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Actual): May 9, 2024
• Study Completion (Actual): May 9, 2024

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-0529; NCI-2022-08945 (Other Identifier: NCI- CTRP Clinical Trial 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