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A Pilot Clinical Trial to Determine the Feasibility of Administering an Electronic Tool to Assess Postoperative pAin, Nausea, and Vomiting in English or Spanish-Speaking Pediatric Patients With Neoplastic Conditions.

Primary Purpose

Neoplastic Conditions

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Augmented reality (AR)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplastic Conditions

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ages 7-17 years old, Able to provide assent, and a legal guardian able to provide informed consent Current diagnosis of pediatric cancer or benign neoplasm, Surgery with an estimated duration longer than 2 hours, An expected prescription of opioids during the inpatient perioperative period Demonstrate capacity to comprehend and interact with the game in English or Spanish. Exclusion criteria: Any concerns from the principal investigator or primary team about the use of the app, Inability or refusal from the parents to provide written informed consent.

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Augmented reality (AR)

Arm Description

Augmented reality (AR) Participants will view the real world through a device's camera and application ("app") but adds virtual or digital characters and items to the image

Outcomes

Primary Outcome Measures

Activation and use of the technology (YES versus NO)

Secondary Outcome Measures

Full Information

First Posted
June 19, 2023
Last Updated
June 27, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Institute of Drug Abuse
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1. Study Identification

Unique Protocol Identification Number
NCT05933252
Brief Title
A Pilot Clinical Trial to Determine the Feasibility of Administering an Electronic Tool to Assess Postoperative pAin, Nausea, and Vomiting in English or Spanish-Speaking Pediatric Patients With Neoplastic Conditions.
Official Title
A Pilot Clinical Trial to Determine the Feasibility of Administering an Electronic Tool to Assess Postoperative pAin, Nausea, and Vomiting in English or Spanish-Speaking Pediatric Patients With Neoplastic Conditions.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
December 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Institute of Drug Abuse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The feasibility of using an electronic tool to measure pain, nausea, and vomiting after surgery in English or Spanish-speaking pediatric cancer patients.
Detailed Description
Primary Objective: To determine the feasibility of administering an AR-based electronic tool to assess postoperative pain, nausea, and vomiting in English or Spanish-speaking pediatric patients with neoplastic conditions. Secondary Objectives: To evaluate the willingness to use the AR app, To evaluate the time spent using the AR app (recorded in the study device), To calculate the difference (delta) between pain and nausea intensity recorded from the app and those gathered by nursing personnel, To evaluate app recorded responses to pain intensity, To evaluate app recorded responses to nausea intensity, To assess the frequency of vomiting, To measure the length of stay in PACU (calculated from the EMR), To determine the rate (number) of assessments completed, To calculate PACU opioid use, To calculate opioid use during hospitalization, To assess the quality of life using the PedsQL Cancer Module survey responses (administered by the study team), To evaluate patient/caregiver satisfaction following the PACU stay To assess nursing experience with AR tool following patient discharge from PACU. Exploratory Objectives: To assess the primary/secondary outcomes for the English and Spanish-speaking patients separately. To correlate pain-reported intensity to the analgesia nociception index (ANI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplastic Conditions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Augmented reality (AR)
Arm Type
Experimental
Arm Description
Augmented reality (AR) Participants will view the real world through a device's camera and application ("app") but adds virtual or digital characters and items to the image
Intervention Type
Other
Intervention Name(s)
Augmented reality (AR)
Intervention Description
an app on an iPad every 15 minutes
Primary Outcome Measure Information:
Title
Activation and use of the technology (YES versus NO)
Time Frame
through study completion; an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 7-17 years old, Able to provide assent, and a legal guardian able to provide informed consent Current diagnosis of pediatric cancer or benign neoplasm, Surgery with an estimated duration longer than 2 hours, An expected prescription of opioids during the inpatient perioperative period Demonstrate capacity to comprehend and interact with the game in English or Spanish. Exclusion criteria: Any concerns from the principal investigator or primary team about the use of the app, Inability or refusal from the parents to provide written informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Cata, MD
Phone
(713) 792-7452
Email
jcata@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Cata, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Cata, MD
Phone
713-792-7452
Email
jcata@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Juan Cata, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

A Pilot Clinical Trial to Determine the Feasibility of Administering an Electronic Tool to Assess Postoperative pAin, Nausea, and Vomiting in English or Spanish-Speaking Pediatric Patients With Neoplastic Conditions.

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