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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677531
• Other study ID #: STUDY00018053
• Secondary ID: NCI-2018-01505ST
• Status: Completed
• Phase: Phase 1
• Start date: May 31, 2018
• Est. completion date: September 25, 2019

Study information

• Verified date: April 2020
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 25, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Radiation:
• Radiation Therapy
Undergo RT

Other:
• Video
Watch video of choice during RT

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of sedation use calculated using number of treatment sessions	A 1-sided binomial test will be used.	Up to 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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