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

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy; Other: Video

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Other (radiation therapy, videos); Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Radiation: Radiation Therapy; Undergo RT; Other Names: Cancer Radiotherapy; Irradiate; Irradiated; Irradiation; Radiation; Radiation Therapy, NOS; Radiotherapeutics; RT; Therapy, Radiation; RADIOTHERAPY; Other: Video; Watch video of choice during RT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: National Cancer Institute (NCI); Oregon Health and Science University
• Investigators: Principal Investigator: Jerry J Jaboin, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2018
• Primary Completion (ACTUAL): September 25, 2019
• Study Completion (ACTUAL): September 25, 2019

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (ACTUAL): September 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: STUDY00018053 (OTHER: OHSU Knight Cancer Institute); P30CA069533 (U.S. NIH Grant/Contract); NCI-2018-01505 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No