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

Phase 1

Completed

• Conditions: Malignant Neoplasm
• Interventions: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy; Other: Video

• Registration Number: NCT03677531
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-05-31
• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Primary Completion: 2019-09-25
• Study Completion: 2019-09-25
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• All races and genders will be included.
• Patients with all tumor types will be included.

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Exclusion Criteria

• Patients < 3 years and > 13 years of age will be excluded.
• Patients with underlying movement disorders will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Other (radiation therapy, videos)	Questionnaire Administration	Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
Other (radiation therapy, videos)	Video	Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
Other (radiation therapy, videos)	Quality-of-Life Assessment	Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
Other (radiation therapy, videos)	Radiation Therapy	Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.

Primary Outcome Measures

Name	Time	Method
Rate of sedation use calculated using number of treatment sessions	Up to 1 year	A 1-sided binomial test will be used.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States