Pediatric CancerPhase 1GAMINGNCT04674150
A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients
A Phase 1 study testing ARISE with AR and ARISE without AR in people with Pediatric Cancer and Surgery, run by ALTality, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pediatric Cancer, Surgery
- What is being tested?
- ARISE with AR and ARISE without AR
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2021to 30 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
M.D. Anderson Cancer Center
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
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)
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.
- Conditions
- Pediatric Cancer, Surgery
- Being tested
- ARISE with AR, ARISE without AR
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARISE with ARDevice
An augmented reality game for mobile devices with AR experiences enabled
ARISE without ARDevice
An augmented reality game for mobile devices with AR experiences disabled as an control
| Study group | Role | What they receive |
|---|---|---|
| Non-AR Group | Sham comparator | 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. Receives: Device: ARISE without AR |
| AR Group | Active comparator | Patients randomized to the AR group will be able to use the iPad and SpellBound app to initiate the AR experiences in the game. Receives: Device: ARISE with AR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who receive the AR game who are able to initiate the game and activate any targets with 1% error rate
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
Measured: The patient's postoperative inpatient hospital stay, average 7 days
Secondary outcomes (10)
Inpatient opioid use
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
Measured: The patient's postoperative inpatient hospital stay, average 7 days
Outpatient opioid use
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.
Measured: The patient's postoperative inpatient hospital stay, average 7 days
Average daily inpatient pain score
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.
Measured: The patient's postoperative inpatient hospital stay, average 7 days
Number of opioid requests (rescue analgesia)
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.
Measured: The patient's postoperative inpatient hospital stay, average 7 days
Quality of life assessment
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.
Measured: The patient's postoperative inpatient hospital stay, average 7 days
Ambulation/ "out of bed" movement
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.
Measured: The patient's postoperative inpatient hospital stay, average 7 days
Discharge-ready status
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.
Measured: The patient's postoperative inpatient hospital stay, average 7 days
Patient experience
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.
Measured: The patient's postoperative inpatient hospital stay, average 7 days
Outpatient pain scores
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
Measured: 90 days after the patient is discharged from the hospital
Outpatient quality of life
Age-appropriate Pediatric Quality of Life Inventory (PedsQL) surveys will be administered to the patient (self-report) or guardian (proxy) by phone.
Measured: 90 days after the patient is discharged from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start13 Jan 2021
- Primary completion31 Aug 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALTality, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), M.D. Anderson Cancer Center, Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Christina York, Principal investigator, ALTality, Inc.Juan Cata, MD, Principal investigator, The University of Texas at Houston MD Anderson Cancer CenterJamie Sinton, MD, Principal investigator, The Texas Children's HospitalJae Eun Choi, Study director, ALTality, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674150
- Sponsor's protocol ID
- ARISE GAMING (Phase I)
- Other IDs
- 1R42DA050365-01A1
- Acronym
- GAMING
- Status last verified
- Aug 2021
- First submitted
- 8 Dec 2020
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified clinical data and statistical analyses included as a part of a publication will be shared with the scientific community per journal guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04674150
- Acronym / sponsor ID
- GAMING / ARISE GAMING (Phase I)
- Conditions
- Pediatric Cancer, Surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ALTality, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), M.D. Anderson Cancer Center, Baylor College of Medicine
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-AR Group | Sham comparator | Device: ARISE without ARPatients 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. |
| AR Group | Active comparator | Device: ARISE with ARPatients randomized to the AR group will be able to use the iPad and SpellBound app to initiate the AR experiences in the game. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARISE with ARAn augmented reality game for mobile devices with AR experiences enabled | Device | AR Group |
| ARISE without ARAn augmented reality game for mobile devices with AR experiences disabled as an control | Device | Non-AR Group |
Primary outcome
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
10 secondary outcomes
Inpatient opioid use
Time frame: 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
Average daily inpatient pain score
Time frame: 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
Quality of life assessment
Time frame: 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
Discharge-ready status
Time frame: The patient's postoperative inpatient hospital stay, average 7 days
Patient experience
Time frame: 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
Outpatient quality of life
Time frame: 90 days after the patient is discharged from the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: Yes. De-identified clinical data and statistical analyses included as a part of a publication will be shared with the scientific community per journal guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina York principal investigator
ALTality, Inc.
Juan Cata, MD principal investigator
The University of Texas at Houston MD Anderson Cancer Center
Jamie Sinton, MD principal investigator
The Texas Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARISE with AR and ARISE without AR in people with Pediatric Cancer and Surgery, run by ALTality, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.