A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Tolerant Users Undergoing Surgery to Reduce Post-operative Opioid Use

NCT05589857 | Withdrawn Phase 2

• 2 other identifiers: 2022-0529NCI-2022-08945
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Pediatric Quality of Life Inventory

  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.

  through completion of study, an average of 1 year

Study Arms (2)

Group 1 (Spellbound)

EXPERIMENTAL

Participants will play SpellBound using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world.

Device: IPAD

Group 2 (Spellbound)

EXPERIMENTAL

Participants will play the game using augmented reality.

Device: Augmented Reality

Interventions

IPAD DEVICE

Participants will play a game using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world.

Group 1 (Spellbound)

Augmented Reality DEVICE

Participants will play a game through (device camera and application) that add virtual or digital characters and items that let 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 surgery 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
• Prescribed daily opioids for pain for a period equal to or longer than 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:

• Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
• Inability to demonstrate an understanding of the game from English instructions
• Any additional concerns based on the study physicians' assessments b. Setting: Academic tertiary cancer center: University of Texas - MD Anderson Cancer Center and Baylor College of Medicine - Texas Children's Hospital

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms

Study Officials

• Juan Cata, MD

  MD Anderson

  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: October 17, 2022
• First Posted: October 21, 2022
• Study Start: October 25, 2022
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-05

Locations

US (1)