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

Early Phase 1

Active, not recruiting

• Conditions: Pain; Pediatric Cancer
• Interventions: Device: AR Pain assessment

• Registration Number: NCT06635434
• Lead Sponsor: ALTality, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-05
• Study First Submitted: 2024-09-19
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2024-10-31
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Augmented reality-enabled pain assessment deployed on a mobile	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total time spent playing on the AR app during the PACU stay	immediately after the intervention/procedure/surgery	Length of time (minutes) of app usage recorded by the device ID for each patient
Recorded responses about pain assessment from the app	immediately after the intervention/procedure/surgery	Pain scale score in English or Spanish through the app
Recorded responses about nausea/vomit assessment from the app	immediately after the intervention/procedure/surgery	Baxter animated retching scale score in English or Spanish through the app
Inpatient opioid consumption	immediately after the intervention/procedure/surgery	Calculated as morphine equivalent dose of all opioids given
Length of stay	immediately after the intervention/procedure/surgery	Total time (minutes) spent in the PACU after surgery
Quality of life survey	immediately after the intervention/procedure/surgery	PedsQL survey administered to child and/or adult caregiver stratified by age
Rate of opioid prescription	immediately after the intervention/procedure/surgery	The percentage of patients with opioid prescriptions at the time of discharge from the electronic health record
Patient/caregiver satisfaction survey	immediately after the intervention/procedure/surgery	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?

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States