Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anxiety, Radiation. Basic parameters: 2 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- Safety and Adverse Events (AEs) [Time frame: Through study completion; an average of 1 year.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- UT MD Anderson — Houston
Identifiers
NCT: NCT07575815 · 2026-0247 · NCI-2026-03503