Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort
Purpose
This is a prospective, observational cohort study of pediatric patients ages 2-12 undergoing radiation therapy at MD Anderson Cancer Center.
Conditions
- Anxiety
- Radiation
Eligibility
- Eligible Ages
- Between 2 Years and 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
To be eligible to participate in this study, an individual must meet all of the following criteria: - Provision of signed and dated informed consent from a parent or legal guardian. - For children age 7 and older, provision of informed assent in addition to parental consent, consistent with institutional guidelines. - Stated willingness of parent/guardian and child (as appropriate) to comply with study procedures (i.e., observation during scheduled radiation therapy appointments). - Male or female, ages 2-12 years. - Scheduled to undergo radiation therapy at MD Anderson Cancer Center.
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study: - Has already completed the simulation session for radiation therapy prior to enrollment. - Declines parental consent or, when applicable, child assent.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
Detailed Description
Primary Objective: The primary objective of this study is to characterize procedural anxiety trajectories in pediatric patients ages 2-12 undergoing radiation therapy. Anxiety will be measured using the Modified Yale Preoperative Anxiety Scale Short Form (mYPAS-SF) at standardized clinical milestones (simulation, first week of treatment, mid-treatment, and final treatment week). Secondary Objectives: Secondary objectives are to explore associations between observed anxiety levels and treatment-related contextual factors, including: - Treatment fraction number - Anesthesia use - Child-life support - Parent or caregiver presence - Waiting times of 30 minutes or longer - Time of day
