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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anesthesia

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Audio-Visual Assisted Therapeutic Ambience in Radiotherapy<br> | Device: Audio-Visual Assisted Therapeutic Ambience in Radiotherapy<br>* Audio Visual System<br>* Other names: AVATAR;Other: Quality of Life Survey, PedsQL3.0<br>* Quality of life survey using the PedsQL 3.0 Cancer Module<br>Other: Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)<br>* Yale Preoperative Anxiety Scale Short Form (mYPAS-SF).[24] is a survey to measure anxiety<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy