Video Distraction to Decrease Use of Sedation in Pediatric Participants During Radiation Therapy

Study Overview
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Brief Summary
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This phase I pilot trial studies how well video distraction works to decrease the use of sedation in pediatric participants during radiation therapy. Radiation treatment requires participants to lie very still (for accuracy). Many children cannot do this without sedation. Watching movies during radiation may distract children so they don't need sedation to complete treatment.

Detailed Description
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PRIMARY OBJECTIVE: I. To determine if the use of video distraction during radiation therapy (VidRT) during radiation for patients ages 3 to 13 decreases the rate of sedation use compared to patients previously treated without VidRT. SECONDARY OBJECTIVE: I. To determine which variables are associated with decreased need for sedation use. Variables will include patient age, length of treatment time (number of treatments and beam-on time), oncologic diagnosis, use of immobilization devices, pre-existing developmental or psychiatric diagnoses (attention deficit hyperactivity disorder [ADHD], dissociative disorders [DD], anxiety, depression, developmental delay, learning disability), pain scale ratings at time of first radiation treatment (0-10). EXPLORATORY OBJECTIVES: I. To determine the impact of VidRT on patient-reported quality of life prior to starting, during, and at the end of treatment using the pediatric quality of life inventory surveys including the Pediatric Quality of Life Inventory (PedsQL) - 4.0 Core and Peds QL- 3.0 brain tumor questionnaires. II. To determine the impact of VidRT on patient-reported anxiety throughout radiation treatment as monitored by Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric item bank version (v) 2.0 anxiety questionnaire. III. To determine if workup assessment category for patient being low, medium, or high risk of needing sedation correlates to actual sedation use. OUTLINE: Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.

Official Title
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VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Radiation: Radiation Therapy
* Other: Video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All races and genders will be included. Patients with all tumor types will be included. Exclusion Criteria: Patients < 3 years and > 13 years of age will be excluded. Patients with underlying movement disorders will be excluded.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 13 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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Other (radiation therapy, videos)<br>Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Radiation: Radiation Therapy<br>* Undergo RT<br>* Other names: Therapy, Radiation;Other: Video<br>* Watch video of choice during RT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of sedation use calculated using number of treatment sessions | A 1-sided binomial test will be used. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient age and association with decreased sedation use | A multivariate analysis will be used to determine which variables correlate with increased sedation use. | Up to 1 year | 
| Number of treatments and association with decreased sedation use | A multivariate analysis will be used to determine which variables correlate with increased sedation use. | Up to 1 year | 
| Beam on-time and association with decreased sedation use | A multivariate analysis will be used to determine which variables correlate with increased sedation use | Up to 1 year | 
| Oncologic diagnosis and association with decreased sedation use | A multivariate analysis will be used to determine which variables correlate with increased sedation use. | Up to 1 year | 
| Use of immobilization device and association with decreased sedation use | A multivariate analysis will be used to determine which variables correlate with increased sedation use. | Up to 1 year | 
| Pre-existing developmental delay or psychiatric diagnosis and association with decreased sedation use | A multivariate analysis will be used to determine which variables correlate with increased sedation use. | Up to 1 year | 
| Pain at time of first radiation treatment and association with decreased sedation use (on a scale of one to ten) | A multivariate analysis will be used to determine which variables correlate with increased sedation use. | Up to 1 year |