NCT07575815RecruitingNot Applicable
Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 20
- Locations
- 1
Study Overview
Brief Summary
This is a prospective, observational cohort study of pediatric patients ages 2-12 undergoing radiation therapy at MD 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- 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.
Investigators
Study Sites (1)
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