Clinical trial NCT05466994: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pediatric ALL
Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-07-20
Enrollment: 29
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Pediatric Quality of Life Inventory Questionnaires
timeFrame: through completion of study, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Juan Cata, MD
role: PRINCIPAL_INVESTIGATOR
References: