Malignant Neoplasm
Conditions
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.
Interventions
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
RADIATIONRadiation Therapy
Undergo RT
OTHERVideo
Watch video of choice during RT
Sponsors
National Cancer Institute (NCI)
Oregon Health and Science University
OHSU Knight Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of sedation use calculated using number of treatment sessions | Up to 1 year | A 1-sided binomial test will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed