- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04674150
A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients (GAMING)
August 13, 2021 updated by: ALTality, Inc.
A Pilot Randomized Controlled Trial to Determine the Feasibility of Administering an auGmented reAlity gaMe to pediatrIc caNcer Patients underGoing Surgery (A GAMING Study)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Texas Children's Hospital
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Houston, Texas, United States, 77030
- M.D. Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 3-18
- English speaking parents/legal guardians and patients
- 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
- Expected to be prescribed postoperative inpatient opioids
- Have never taken opioids or have had no daily opioid use within the last 30 days
- 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.
- Both child and a legal guardian are willing and able to provide informed consent.
Exclusion Criteria:
- History of documented peripheral neuropathy secondary to cancer treatment
- Inability to demonstrate an understanding of the game from English instructions
- Have previous played the ARISETM digital scavenger hunt game
- Any additional concerns based on the study physicians' assessments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: Non-AR Group
Patients allocated to the control group will be able to interact with the iPad and visualize objects and decals in the walls but not able to initiate the AR technology.
In other terms, patients in this group will be provided with the same iPad to the AR group patients with the only exception that the AR technology will be off and will only see objects through the device camera in normal reality.
|
An augmented reality game for mobile devices with AR experiences disabled as an control
|
ACTIVE_COMPARATOR: AR Group
Patients randomized to the AR group will be able to use the iPad and SpellBound app to initiate the AR experiences in the game.
|
An augmented reality game for mobile devices with AR experiences enabled
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients who receive the AR game who are able to initiate the game and activate any targets with 1% error rate
Time Frame: The patient's postoperative inpatient hospital stay, average 7 days
|
Success defined as at least 80% of patients who receive the AR game being able to initiate the game and activate any targets with 1% error rate
|
The patient's postoperative inpatient hospital stay, average 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inpatient opioid use
Time Frame: The patient's postoperative inpatient hospital stay, average 7 days
|
The average daily inpatient MEDD (morphine equivalent dose) will be calculated from the electronic medical record as previously used in pediatric cancer surgical patients by the investigator
|
The patient's postoperative inpatient hospital stay, average 7 days
|
Outpatient opioid use
Time Frame: The patient's postoperative inpatient hospital stay, average 7 days
|
We will record whether the patient has any active opioid prescription 90-days (±10 Days) after surgery.
This data will be confirmed by direct contact to patients' caregivers or via pharmacy registries on filled prescriptions.
|
The patient's postoperative inpatient hospital stay, average 7 days
|
Average daily inpatient pain score
Time Frame: The patient's postoperative inpatient hospital stay, average 7 days
|
Age-appropriate pain-intensity scores will be determined using Visual and Colored Analogue Scales (VAS).
This is a 10-point colored scaled validated for measuring pain intensity in pediatric populations and will be assessed twice daily at 9AM and 5PM.
|
The patient's postoperative inpatient hospital stay, average 7 days
|
Number of opioid requests (rescue analgesia)
Time Frame: The patient's postoperative inpatient hospital stay, average 7 days
|
We will record the total number of times opioids were required by patients to nurses and the patient-controlled analgesia infusion pumps during the inpatient period as recorded in the electronic medical record.
|
The patient's postoperative inpatient hospital stay, average 7 days
|
Quality of life assessment
Time Frame: The patient's postoperative inpatient hospital stay, average 7 days
|
Age-appropriate Pediatric Quality of Life Inventory (PedsQL) paper surveys will be administered to the patient (self-report) or guardian (proxy) when patients reach discharge-ready status.
|
The patient's postoperative inpatient hospital stay, average 7 days
|
Ambulation/ "out of bed" movement
Time Frame: The patient's postoperative inpatient hospital stay, average 7 days
|
Distance (meters) achieved "out of bed" (ambulatory or non-ambulatory/wheelchair) during their inpatient stay while interacting with the app will be calculated by hand, based on how many times patient activated specific targets.
|
The patient's postoperative inpatient hospital stay, average 7 days
|
Discharge-ready status
Time Frame: The patient's postoperative inpatient hospital stay, average 7 days
|
The number of days to discharge-ready status will be determined by the study physicians.
This status will be assessed twice daily at 9AM and 5PM.
|
The patient's postoperative inpatient hospital stay, average 7 days
|
Patient experience
Time Frame: The patient's postoperative inpatient hospital stay, average 7 days
|
In the patients who receive the AR game, responses to an electronic survey on the patient's experience designed by the MDACC Child Life team will be recorded when patients reach discharge-ready status.
|
The patient's postoperative inpatient hospital stay, average 7 days
|
Outpatient pain scores
Time Frame: 90 days after the patient is discharged from the hospital
|
We will record average pain intensity experience by the patient during the 90-day (±10 Days) post surgery period.
This data will be confirmed by direct contact to patient's guardian or as recorded in the electronic medical record during the patient's follow-up clinic visit
|
90 days after the patient is discharged from the hospital
|
Outpatient quality of life
Time Frame: 90 days after the patient is discharged from the hospital
|
Age-appropriate Pediatric Quality of Life Inventory (PedsQL) surveys will be administered to the patient (self-report) or guardian (proxy) by phone.
|
90 days after the patient is discharged from the hospital
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: Through study completion, average 4-month time period
|
Any adverse events clinically determined to be related to the use of AR (i.e., falls) will be recorded
|
Through study completion, average 4-month time period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christina York, ALTality, Inc.
- Principal Investigator: Juan Cata, MD, The University of Texas at Houston MD Anderson Cancer Center
- Principal Investigator: Jamie Sinton, MD, The Texas Children's Hospital
- Study Director: Jae Eun Choi, ALTality, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 13, 2021
Primary Completion (ANTICIPATED)
August 31, 2021
Study Completion (ANTICIPATED)
November 30, 2021
Study Registration Dates
First Submitted
December 8, 2020
First Submitted That Met QC Criteria
December 13, 2020
First Posted (ACTUAL)
December 19, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 16, 2021
Last Update Submitted That Met QC Criteria
August 13, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ARISE GAMING (Phase I)
- 1R42DA050365-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified clinical data and statistical analyses included as a part of a publication will be shared with the scientific community per journal guidelines.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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