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)

Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466994
• Other study ID #: 2022-0336
• Secondary ID: NCI-2022-05979
• Status: Recruiting
• Phase: Phase 2
• Start date: August 19, 2022
• Est. completion date: October 31, 2026

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Juan Cata, MD
• Phone: (713) 792-7452
• Email: jcata[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Pediatric ALL

Intervention

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
• Augmented Reality
Participants will play a game through (devices camera and application) let us participants view the real world

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center