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

Sponsor
Stanford University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03991156
Collaborator
(none)
80
Enrollment
11
Locations
1
Arm
39.2
Anticipated Duration (Months)
7.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Audio-Visual Assisted Therapeutic Ambience in Radiotherapy
  • Other: Quality of Life Survey, PedsQL3.0
  • Other: Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study
Actual Study Start Date :
May 28, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

    Outcome Measures

    Primary Outcome Measures

    1. Success rate of AVATAR system [24 months]

      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.

    Secondary Outcome Measures

    1. Measure Fractional Success using AVATAR system [24 months]

      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.

    2. Determine the difference in patient anxiety between successful AVATAR patients and not-successful patients. [24 months]

      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.

    3. Compare the rates of anesthesia with historical controls [24 months]

      Compare the rates of anesthesia use between patients using AVATAR to historical controls who were not introduced to AVATAR.

    4. Determine the rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR [24 months]

      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.

    5. Difference in health quality of life between subjects with or without anesthesia [24 months]

      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)

    6. Assess predictability for AVATAR patient success [24 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94304
    2 Indiana University Bloomington Indiana United States 47405
    3 Johns Hopkins University Baltimore Maryland United States 21218
    4 Dana Farber Cancer Institute/Brigham & Women Children Hospital Boston Massachusetts United States 02215
    5 University of Minnesota Minnesota Minnesota United States 55455
    6 St. Louis Children's Hospital Saint Louis Missouri United States 63110
    7 University of Rochester School of Medicine Rochester New York United States 14642
    8 University North Carolina Chapel Hill North Carolina United States 27599
    9 Cincinnati Children's/UC Health Proton Therapy Center Cincinnati Ohio United States 45229
    10 Oregon Health and Science University Portland Oregon United States 97239
    11 St. Jude Children Hospital Memphis Tennessee United States 38105

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Susan M Hiniker, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT03991156
    Other Study ID Numbers:
    • IRB-47864
    • PEDSVAR0050
    • IRB-47864
    First Posted:
    Jun 19, 2019
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Stanford University
    Radiotherapy

    Study Results

    No Results Posted as of Feb 11, 2022