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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03991156
• Other study ID #: IRB-47864
• Secondary ID: PEDSVAR0050IRB-4
• Status: Active, not recruiting
• Start date: May 28, 2019
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Audio-Visual Assisted Therapeutic Ambience in Radiotherapy
Audio Visual System

Other:
• Quality of Life Survey, PedsQL3.0
Quality of life survey using the PedsQL 3.0 Cancer Module
• Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)
Yale Preoperative Anxiety Scale Short Form (mYPAS-SF).[24] is a survey to measure anxiety

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Indiana University	Bloomington	Indiana
United States	Dana Farber Cancer Institute/Brigham & Women Children Hospital	Boston	Massachusetts
United States	University North Carolina	Chapel Hill	North Carolina
United States	Cincinnati Children's/UC Health Proton Therapy Center	Cincinnati	Ohio
United States	St. Jude Children Hospital	Memphis	Tennessee
United States	University of Minnesota	Minnesota	Minnesota
United States	Oregon Health and Science University	Portland	Oregon
United States	University of Rochester School of Medicine	Rochester	New York
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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