AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study
3 other identifiers
observational
80
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2019
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 28, 2019
CompletedFirst Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
June 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 13, 2026
April 1, 2026
7.5 years
June 12, 2019
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Measure Fractional Success using AVATAR system
24 months
Determine the difference in patient anxiety between successful AVATAR patients and not-successful patients.
24 months
Compare the rates of anesthesia with historical controls
24 months
Determine the rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR
24 months
Difference in health quality of life between subjects with or without anesthesia
24 months
- +1 more secondary outcomes
Study Arms (1)
Audio-Visual Assisted Therapeutic Ambience in Radiotherapy
Interventions
Yale Preoperative Anxiety Scale Short Form (mYPAS-SF).\[24\] is a survey to measure anxiety
Audio Visual System
Quality of life survey using the PedsQL 3.0 Cancer Module
Eligibility Criteria
The age range of patients is 3-10 years old, and there is no discrimination on ethnic background in recruitment for this study.
You may qualify if:
- Pediatric patients ages 3-10 receiving radiotherapy qualify for enrollment.
- The patient must speak English or Spanish.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Stanford University
Stanford, California, 94304, United States
Indiana University
Bloomington, Indiana, 47405, United States
Johns Hopkins University
Baltimore, Maryland, 21218, United States
Dana Farber Cancer Institute/Brigham & Women Children Hospital
Boston, Massachusetts, 02215, United States
University of Minnesota
Minneota, Minnesota, 55455, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
University of Rochester School of Medicine
Rochester, New York, 14642, United States
University North Carolina
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's/UC Health Proton Therapy Center
Cincinnati, Ohio, 45229, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
St. Jude Children Hospital
Memphis, Tennessee, 38105, United States
Related Publications (1)
Gutkin PM, Skinner L, Jiang A, Donaldson SS, Loo BW Jr, Oh J, Wang YP, von Eyben R, Snyder J, Bredfeldt JS, Breneman JC, Constine LS, Faught AM, Haas-Kogan D, Holmes JA, Krasin M, Larkin C, Marcus KJ, Maxim PG, McClelland S 3rd, Murphy B, Palmer JD, Perkins SM, Shen CJ, Terezakis S, Bush K, Hiniker SM. Feasibility of the Audio-Visual Assisted Therapeutic Ambience in Radiotherapy (AVATAR) System for Anesthesia Avoidance in Pediatric Patients: A Multicenter Trial. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):96-104. doi: 10.1016/j.ijrobp.2023.03.063. Epub 2023 Mar 30.
PMID: 37001762DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan M Hiniker
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2019
First Posted
June 19, 2019
Study Start
May 28, 2019
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share