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

NCT06635434 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: 1R43DA057744-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Total time spent playing on the AR app during the PACU stay

  immediately after the intervention/procedure/surgery

• Recorded responses about pain assessment from the app

  immediately after the intervention/procedure/surgery

• Recorded responses about nausea/vomit assessment from the app

  immediately after the intervention/procedure/surgery

• Inpatient opioid consumption

  immediately after the intervention/procedure/surgery

• Length of stay

  immediately after the intervention/procedure/surgery

Study Arms (1)

Augmented reality-enabled pain assessment deployed on a mobile

EXPERIMENTAL

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

Interventions

AR Pain assessment DEVICE

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

Augmented reality-enabled pain assessment deployed on a mobile

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ALTality, Inc.: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77054, United States

Location

Related Publications (2)

• 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.

  PMID: 27258079 BACKGROUND

• 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.

  PMID: 27802492 BACKGROUND

MeSH Terms

Conditions

Pain; Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christina York

  ALTality, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 10, 2024
• Study Start: February 5, 2023
• Primary Completion: October 31, 2024
• Study Completion: November 30, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)