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| ID | Type | Description | Link |
|---|---|---|---|
| 1R42DA050365-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| M.D. Anderson Cancer Center | OTHER |
| Baylor College of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARISE with AR | Device | An augmented reality game for mobile devices with AR experiences enabled |
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| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The patient's postoperative inpatient hospital stay, average 7 days |
| Outpatient opioid use |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Jae Eun Choi | ALTality, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| Texas Children's Hospital |
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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 11, 2022 | |
| Reset | Sep 1, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 11, 2022 | Sep 1, 2022 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ARISE without AR | Device | An augmented reality game for mobile devices with AR experiences disabled as an control |
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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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Houston |
| Texas |
| 77030 |
| United States |