OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
NCT Number: NCT03677531
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.
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Notify Me3 year–13 year
All sexes
Interventional
Phase 1
Portland, Oregon, 97239, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Undergo RT
Other names: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation
Watch video of choice during RT
Time frame: Up to 1 year
A 1-sided binomial test will be used.
Time frame: Up to 1 year
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
Time frame: Up to 1 year
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
Time frame: Up to 1 year
A multivariate analysis will be used to determine which variables correlate with increased sedation use
Time frame: Up to 1 year
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
Time frame: Up to 1 year
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
Time frame: Up to 1 year
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
Time frame: Up to 1 year
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
OHSU Knight Cancer Institute
Other
VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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