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

Surgery Clinical Trial

— GAMING  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04674150
• Other study ID #: ARISE GAMING (Phase I)
• Secondary ID: 1R42DA050365-01A
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 13, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: August 2021
• Source: ALTality, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Ages 3-18

2. English speaking parents/legal guardians and patients

3. 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

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

6. 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.

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

Exclusion Criteria:

1. History of documented peripheral neuropathy secondary to cancer treatment

2. Inability to demonstrate an understanding of the game from English instructions

3. Have previous played the ARISETM digital scavenger hunt game

4. Any additional concerns based on the study physicians' assessments

Related Conditions & MeSH terms

• Pediatric Cancer
• Surgery

Intervention

Device:
• ARISE with AR
An augmented reality game for mobile devices with AR experiences enabled
• ARISE without AR
An augmented reality game for mobile devices with AR experiences disabled as an control

Locations

Country	Name	City	State
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
ALTality, Inc.	Baylor College of Medicine, M.D. Anderson Cancer Center, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Any adverse events clinically determined to be related to the use of AR (i.e., falls) will be recorded	Through study completion, average 4-month time period
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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