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

Active, not recruiting

• Conditions: Anesthesia
• Interventions: Device: Audio-Visual Assisted Therapeutic Ambience in Radiotherapy; Other: Quality of Life Survey, PedsQL3.0; Other: Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)

• Registration Number: NCT03991156
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-28
• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Audio-Visual Assisted Therapeutic Ambience in Radiotherapy	Quality of Life Survey, PedsQL3.0	-
Audio-Visual Assisted Therapeutic Ambience in Radiotherapy	Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)	-
Audio-Visual Assisted Therapeutic Ambience in Radiotherapy	Audio-Visual Assisted Therapeutic Ambience in Radiotherapy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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)
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.
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.
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.
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.

Trial Locations

Locations (11)

Stanford University; 🇺🇸 Stanford, California, 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

St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

University of Rochester School of Medicine; 🇺🇸 Rochester, New York, United States

University North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Cincinnati Children's/UC Health Proton Therapy Center; 🇺🇸 Cincinnati, Ohio, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

St. Jude Children Hospital; 🇺🇸 Memphis, Tennessee, United States

University of Minnesota; 🇺🇸 Minnesota, Minnesota, United States