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)

NCT05466994 | Completed Phase 2 DMC

• 2 other identifiers: 2022-0336NCI-2022-05979
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Pediatric ALL; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1(Spellbound)

OTHER

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

Group 2 (Spellbound)

OTHER

Participants will play the game using augmented reality

Other: Augmented Reality

Interventions

IPAD OTHER

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

Group 1(Spellbound)

Augmented Reality OTHER

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

Group 2 (Spellbound)

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 5-15
• English and Spanish-speaking parents/legal guardians and patients
• 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
• Expected to be prescribed postoperative inpatient opioids
• Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
• 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.
• 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.

You may not qualify if:

• Patients with any daily opioid use within 30 days before surgery.
• History of documented peripheral neuropathy secondary to cancer treatment
• Inability to demonstrate an understanding of the game from English instructions
• Any additional concerns based on the study physicians' assessments

Sponsors & Collaborators

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

Study Sites (2)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Juan Cata, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 20, 2022
• Study Start: August 19, 2022
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (2)