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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: ARISE without AR
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.
Device: ARISE with AR
An augmented reality game for mobile devices with AR experiences enabled

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ALTality, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
M.D. Anderson Cancer Center
Baylor College of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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