NCT04674150

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

January 13, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

December 8, 2020

Last Update Submit

August 13, 2021

Conditions

Pediatric CancerSurgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • Inpatient opioid use

    The patient's postoperative inpatient hospital stay, average 7 days

  • Outpatient opioid use

    The patient's postoperative inpatient hospital stay, average 7 days

  • Average daily inpatient pain score

    The patient's postoperative inpatient hospital stay, average 7 days

  • Number of opioid requests (rescue analgesia)

    The patient's postoperative inpatient hospital stay, average 7 days

  • Quality of life assessment

    The patient's postoperative inpatient hospital stay, average 7 days

  • +5 more secondary outcomes

Other Outcomes (1)

  • Adverse events

    Through study completion, average 4-month time period

Study Arms (2)

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.

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.

Device: ARISE with AR

Interventions

ARISE with ARDEVICE

An augmented reality game for mobile devices with AR experiences enabled

AR Group
ARISE without ARDEVICE

An augmented reality game for mobile devices with AR experiences disabled as an control

Non-AR Group

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 19, 2020

Study Start

January 13, 2021

Primary Completion

August 31, 2021

Study Completion

November 30, 2021

Last Updated

August 16, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

De-identified clinical data and statistical analyses included as a part of a publication will be shared with the scientific community per journal guidelines.

Locations

US(2)