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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03991156
Recruitment Status : Active, not recruiting
First Posted : June 19, 2019
Last Update Posted : February 8, 2024
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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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
Anesthesia 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 Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Audio-Visual Assisted Therapeutic Ambience in Radiotherapy Device: Audio-Visual Assisted Therapeutic Ambience in Radiotherapy
Audio Visual System
Other Name: 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
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Primary Outcome Measures :
  1. Success rate of AVATAR system [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991156


Locations
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United States, California
Stanford University
Stanford, California, United States, 94304
United States, Indiana
Indiana University
Bloomington, Indiana, United States, 47405
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21218
United States, Massachusetts
Dana Farber Cancer Institute/Brigham & Women Children Hospital
Boston, Massachusetts, United States, 02215
United States, Minnesota
University of Minnesota
Minnesota, Minnesota, United States, 55455
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, New York
University of Rochester School of Medicine
Rochester, New York, United States, 14642
United States, North Carolina
University North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's/UC Health Proton Therapy Center
Cincinnati, Ohio, United States, 45229
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Tennessee
St. Jude Children Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Susan M Hiniker Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT03991156    
Other Study ID Numbers: IRB-47864
PEDSVAR0050 ( Other Identifier: OnCore )
IRB-47864 ( Other Identifier: Stanford IRB )
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: February 8, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Stanford University:
Radiotherapy