Clinical trial NCT04674150: A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients
Official title: A Pilot Randomized Controlled Trial to Determine the Feasibility of Administering an auGmented reAlity gaMe to pediatrIc caNcer Patients underGoing Surgery (A GAMING Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pediatric Cancer
Surgery
Lead sponsor: ALTality, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: M.D. Anderson Cancer Center
name: Baylor College of Medicine
First posted: 2020-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study to evaluate the feasibility of SpellBound's AR (augmented reality)-enabled scavenger hunt use among 20 pediatric cancer patients undergoing surgery.


Eligibility criteria: Inclusion Criteria:

1. Ages 3-18
2. English speaking parents/legal guardians and patients
3. Undergoing major surgery for cancer requiring postoperative hospitalization 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
6. Sufficient cognitive capacity to comprehend and interact with the game. This is defined as 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 child and a legal guardian are willing and able to provide informed consent.

Exclusion Criteria:

1. History of documented peripheral neuropathy secondary to cancer treatment
2. Inability to demonstrate an understanding of the game from English instructions
3. Have previous played the ARISETM digital scavenger hunt game
4. Any additional concerns based on the study physicians' assessments

Primary outcomes:
measure: Percentage of patients who receive the AR game who are able to initiate the game and activate any targets with 1% error rate
timeFrame: The patient's postoperative inpatient hospital stay, average 7 days
Secondary outcomes:
measure: Inpatient opioid use
timeFrame: The patient's postoperative inpatient hospital stay, average 7 days
measure: Outpatient opioid use
timeFrame: The patient's postoperative inpatient hospital stay, average 7 days
measure: Average daily inpatient pain score
timeFrame: The patient's postoperative inpatient hospital stay, average 7 days
measure: Number of opioid requests (rescue analgesia)
timeFrame: The patient's postoperative inpatient hospital stay, average 7 days
measure: Quality of life assessment
timeFrame: The patient's postoperative inpatient hospital stay, average 7 days
measure: Ambulation/ "out of bed" movement
timeFrame: The patient's postoperative inpatient hospital stay, average 7 days
measure: Discharge-ready status
timeFrame: The patient's postoperative inpatient hospital stay, average 7 days
measure: Patient experience
timeFrame: The patient's postoperative inpatient hospital stay, average 7 days
measure: Outpatient pain scores
timeFrame: 90 days after the patient is discharged from the hospital
measure: Outpatient quality of life
timeFrame: 90 days after the patient is discharged from the hospital
Other outcomes:
measure: Adverse events
timeFrame: Through study completion, average 4-month time period
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: ALTality, Inc.
name: Christina York
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas at Houston MD Anderson Cancer Center
name: Juan Cata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Texas Children's Hospital
name: Jamie Sinton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ALTality, Inc.
name: Jae Eun Choi
role: STUDY_DIRECTOR
References: