A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients

Study Overview
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Brief Summary
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This is a pilot study to evaluate the feasibility of SpellBound's AR (augmented reality)-enabled scavenger hunt use among 20 pediatric cancer patients undergoing surgery.

Official Title
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A Pilot Randomized Controlled Trial to Determine the Feasibility of Administering an auGmented reAlity gaMe to pediatrIc caNcer Patients underGoing Surgery (A GAMING Study)

Conditions
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Pediatric Cancer, Surgery

Intervention / Treatment
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* Device: ARISE with AR
* Device: ARISE without AR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 3-18 English speaking parents/legal guardians and patients Undergoing major surgery for cancer requiring postoperative hospitalization defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night Expected to be prescribed postoperative inpatient opioids Have never taken opioids or have had no daily opioid use within the last 30 days Sufficient cognitive capacity to comprehend and interact with the game. This is defined as 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. Both child and a legal guardian are willing and able to provide informed consent. Exclusion Criteria: History of documented peripheral neuropathy secondary to cancer treatment Inability to demonstrate an understanding of the game from English instructions Have previous played the ARISETM digital scavenger hunt game Any additional concerns based on the study physicians' assessments

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Non-AR Group<br>Patients allocated to the control group will be able to interact with the iPad and visualize objects and decals in the walls but not able to initiate the AR technology. In other terms, patients in this group will be provided with the same iPad to the AR group patients with the only exception that the AR technology will be off and will only see objects through the device camera in normal reality. | Device: ARISE without AR<br>* An augmented reality game for mobile devices with AR experiences disabled as an control<br>|
| Active Comparator: AR Group<br>Patients randomized to the AR group will be able to use the iPad and SpellBound app to initiate the AR experiences in the game. | Device: ARISE with AR<br>* An augmented reality game for mobile devices with AR experiences enabled<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who receive the AR game who are able to initiate the game and activate any targets with 1% error rate | Success defined as at least 80% of patients who receive the AR game being able to initiate the game and activate any targets with 1% error rate | The patient's postoperative inpatient hospital stay, average 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inpatient opioid use | The average daily inpatient MEDD (morphine equivalent dose) will be calculated from the electronic medical record as previously used in pediatric cancer surgical patients by the investigator | The patient's postoperative inpatient hospital stay, average 7 days | 
| Outpatient opioid use | We will record whether the patient has any active opioid prescription 90-days (±10 Days) after surgery. This data will be confirmed by direct contact to patients' caregivers or via pharmacy registries on filled prescriptions. | The patient's postoperative inpatient hospital stay, average 7 days | 
| Average daily inpatient pain score | Age-appropriate pain-intensity scores will be determined using Visual and Colored Analogue Scales (VAS). This is a 10-point colored scaled validated for measuring pain intensity in pediatric populations and will be assessed twice daily at 9AM and 5PM. | The patient's postoperative inpatient hospital stay, average 7 days | 
| Number of opioid requests (rescue analgesia) | We will record the total number of times opioids were required by patients to nurses and the patient-controlled analgesia infusion pumps during the inpatient period as recorded in the electronic medical record. | The patient's postoperative inpatient hospital stay, average 7 days | 
| Quality of life assessment | Age-appropriate Pediatric Quality of Life Inventory (PedsQL) paper surveys will be administered to the patient (self-report) or guardian (proxy) when patients reach discharge-ready status. | The patient's postoperative inpatient hospital stay, average 7 days | 
| Ambulation/ out of bed movement | Distance (meters) achieved out of bed (ambulatory or non-ambulatory/wheelchair) during their inpatient stay while interacting with the app will be calculated by hand, based on how many times patient activated specific targets. | The patient's postoperative inpatient hospital stay, average 7 days | 
| Discharge-ready status | The number of days to discharge-ready status will be determined by the study physicians. This status will be assessed twice daily at 9AM and 5PM. | The patient's postoperative inpatient hospital stay, average 7 days | 
| Patient experience | In the patients who receive the AR game, responses to an electronic survey on the patient's experience designed by the MDACC Child Life team will be recorded when patients reach discharge-ready status. | The patient's postoperative inpatient hospital stay, average 7 days | 
| Outpatient pain scores | We will record average pain intensity experience by the patient during the 90-day (±10 Days) post surgery period. This data will be confirmed by direct contact to patient's guardian or as recorded in the electronic medical record during the patient's follow-up clinic visit | 90 days after the patient is discharged from the hospital | 
| Outpatient quality of life | Age-appropriate Pediatric Quality of Life Inventory (PedsQL) surveys will be administered to the patient (self-report) or guardian (proxy) by phone. | 90 days after the patient is discharged from the hospital |