An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients

Feasibility of a Dual English/Spanish Mobile Augmented Reality Pain Assessment App to Reduce Postoperative Prescription Opioid Use in Hispanic/Latino Pediatric and Adolescent Cancer Patients

In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Pediatric Cancer
• Intervention / Treatment: Device: AR Pain assessment

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77054
      • Md Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ages 7-17 years old
• child able to provide assent, and a legal guardian able to provide informed consent
• current diagnosis of pediatric cancer
• undergoing surgery for cancer treatment requiring postoperative inpatient hospitalization
• prescribed or expected to be prescribed opioids during inpatient perioperative period
• sufficient mental capacity to comprehend and interact with the game in English or Spanish.

Exclusion Criteria:

• the inability to play with the SpellBound app from English or Spanish instructions
• daily opioid use within 30 days prior to surgery
• any concerns from the treatment team.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmented reality-enabled pain assessment deployed on a mobile; Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration	Device: AR Pain assessment; Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary; Percent of enrolled patients who activated/used the app during the PACU stay	Feasibility measured as activation/usage of the app recorded by the device ID for each patient	immediately after the intervention/procedure/surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total time spent playing on the AR app during the PACU stay	Length of time (minutes) of app usage recorded by the device ID for each patient	immediately after the intervention/procedure/surgery
Recorded responses about pain assessment from the app	Pain scale score in English or Spanish through the app	immediately after the intervention/procedure/surgery
Recorded responses about nausea/vomit assessment from the app	Baxter animated retching scale score in English or Spanish through the app	immediately after the intervention/procedure/surgery
Inpatient opioid consumption	Calculated as morphine equivalent dose of all opioids given	immediately after the intervention/procedure/surgery
Length of stay	Total time (minutes) spent in the PACU after surgery	immediately after the intervention/procedure/surgery
Quality of life survey	PedsQL survey administered to child and/or adult caregiver stratified by age	immediately after the intervention/procedure/surgery
Rate of opioid prescription	The percentage of patients with opioid prescriptions at the time of discharge from the electronic health record	immediately after the intervention/procedure/surgery
Patient/caregiver satisfaction survey	Asked to the patient/caregiver by the study team - 1) How satisfied were you with regards to your pain management in PACU?, 2) How satisfied were you with regards to your nausea management in PACU?, 3) How satisfied were you with the use of the AR app to help assess your pain and nausea?	immediately after the intervention/procedure/surgery

Collaborators and Investigators

• Sponsor: ALTality, Inc.
• Collaborators: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Christina York, ALTality, Inc.

Publications and helpful links

General Publications

• Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National Trends in Hospitalizations for Opioid Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr. 2016 Dec 1;170(12):1195-1201. doi: 10.1001/jamapediatrics.2016.2154.
• Kamaladevi RK, Elakkumanan LB, Regmi S. Smart Anesthesia-Another Way of Communication During Emergence from Anesthesia Using a Smartphone. Anesth Analg. 2016 Aug;123(2):518. doi: 10.1213/ANE.0000000000001400. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1R43DA057744-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pediatric cancer diagnoses are rare and by definition could identify individual patients and violate patient privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No