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)

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05466994
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 34
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.4
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric ALL; Cancer	Other: IPAD; Other: Augmented Reality	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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)
• Actual Study Start Date: Aug 19, 2022
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pediatric Quality of Life Inventory Questionnaires [through completion of study, an average of 1 year]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Institutes of Health (NIH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05466994
• Other Study ID Numbers: 2022-0336; NCI-2022-05979
• First Posted: Jul 20, 2022
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 23, 2022