AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study

To determine the success rate of the AVATAR audio-visual system. All patients enrolled in the study will be counted, and each patient who is able to undergo at least one fraction without anesthesia will count as a success while each patient who does not have at least one fraction without anesthesia will count as a failure. The success rate will be the proportion of patients who are successes.

Study Overview

• Status: Active, not recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Device: Audio-Visual Assisted Therapeutic Ambience in Radiotherapy; Other: Quality of Life Survey, PedsQL3.0; Other: Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)

• Study Type: Observational
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford University
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute/Brigham & Women Children Hospital
  • Minnesota
    • Minnesota, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester School of Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University North Carolina
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's/UC Health Proton Therapy Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The age range of patients is 3-10 years old, and there is no discrimination on ethnic background in recruitment for this study.

Description

Inclusion Criteria:

• Pediatric patients ages 3-10 receiving radiotherapy qualify for enrollment.
• The patient must speak English or Spanish.

Exclusion Criteria:

• If parent/guardian is unable to take part in helping to complete questionnaires
• Patients with malignancies of the eye for which radiation is planned
• Patients that do not speak English or Spanish

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Audio-Visual Assisted Therapeutic Ambience in Radiotherapy	Device: Audio-Visual Assisted Therapeutic Ambience in Radiotherapy; Audio Visual System; Other Names: AVATAR; Other: Quality of Life Survey, PedsQL3.0; Quality of life survey using the PedsQL 3.0 Cancer Module; Other: Yale Preoperative Anxiety Scale Short Form (mYPAS-SF); Yale Preoperative Anxiety Scale Short Form (mYPAS-SF).[24] is a survey to measure anxiety

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of AVATAR system	Success rate will be determined as the proportion of patients who are successes. Success will be counted as each patient who is able to undergo at least one fraction without anesthesia while each patient who does not have at least one fraction without anesthesia will count as a failure.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure Fractional Success using AVATAR system	Fractional Success will be is counted as a fraction in which the patient does not require anesthesia will count as a fractional success, while a fraction in which the patient required anesthesia will be a fractional failure.	24 months
Determine the difference in patient anxiety between successful AVATAR patients and not-successful patients.	The difference in patient anxiety between successful AVATAR patients and not-successful patients will be determined. Anxiety will be assesed by modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF). mYPAS-SF measurement instrument uses 5 items, each representing a different domain of child anxiety, and is used at 4 points in time.	24 months
Compare the rates of anesthesia with historical controls	Compare the rates of anesthesia use between patients using AVATAR to historical controls who were not introduced to AVATAR.	24 months
Determine the rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR	The rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR will be determined. Conversion is determined by the fraction at which the patient switches from using anesthesia to not using anesthesia.	24 months
Difference in health quality of life between subjects with or without anesthesia	The difference between family-reported health-related quality of life between patients who were able to tolerate treatment without anesthesia using the AVATAR program and patients who required anesthesia for the entire treatment. The quality of life will be measured using Pediatric oncology quality of life inventory 3.0-cancer module (PedsQL 3.0 Cancer Module)	24 months
Assess predictability for AVATAR patient success	AVATAR patient success will be determined by using the predictability of the PedsQL3.0 Cancer and modified Yale Preoperative Assessment Survey Short Form (mYPAS-SF) questionnaires. mYPAS-SF measurement instrument uses 5 items, each representing a different domain of child anxiety, and is used at 4 points in time.	24 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Susan M Hiniker, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy
• Other Study ID Numbers: IRB-47864 (Other Identifier: Stanford IRB); PEDSVAR0050 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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