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

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ClinicalTrials.gov Identifier: NCT03677531
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : May 4, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Oregon Health and Science University
Information provided by (Responsible Party):
Jerry Jaboin, OHSU Knight Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Therapy Other: Video Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation
Actual Study Start Date : May 31, 2018
Actual Primary Completion Date : September 25, 2019
Actual Study Completion Date : September 25, 2019
Arms and Interventions
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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 Name: 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
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation

Other: Video
Watch video of choice during RT


Outcome Measures
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Primary Outcome Measures :
  1. Rate of sedation use calculated using number of treatment sessions [ Time Frame: Up to 1 year ]
    A 1-sided binomial test will be used.


Secondary Outcome Measures :
  1. Patient age and association with decreased sedation use [ Time Frame: Up to 1 year ]
    A multivariate analysis will be used to determine which variables correlate with increased sedation use.

  2. Number of treatments and association with decreased sedation use [ Time Frame: Up to 1 year ]
    A multivariate analysis will be used to determine which variables correlate with increased sedation use.

  3. Beam "on-time" and association with decreased sedation use [ Time Frame: Up to 1 year ]
    A multivariate analysis will be used to determine which variables correlate with increased sedation use

  4. Oncologic diagnosis and association with decreased sedation use [ Time Frame: Up to 1 year ]
    A multivariate analysis will be used to determine which variables correlate with increased sedation use.

  5. Use of immobilization device and association with decreased sedation use [ Time Frame: Up to 1 year ]
    A multivariate analysis will be used to determine which variables correlate with increased sedation use.

  6. Pre-existing developmental delay or psychiatric diagnosis and association with decreased sedation use [ Time Frame: Up to 1 year ]
    A multivariate analysis will be used to determine which variables correlate with increased sedation use.

  7. Pain at time of first radiation treatment and association with decreased sedation use (on a scale of one to ten) [ Time Frame: Up to 1 year ]
    A multivariate analysis will be used to determine which variables correlate with increased sedation use.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677531


Locations
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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Oregon Health and Science University
Investigators
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Principal Investigator: Jerry J Jaboin OHSU Knight Cancer Institute
More Information
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Responsible Party: Jerry Jaboin, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT03677531    
Other Study ID Numbers: STUDY00018053
NCI-2018-01505 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STUDY00018053 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms