Baseline anxiety patterns in children receiving radiation therapy

Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort

This project will track how anxiety changes during radiation treatment in children ages 2–12 to see if specific visits or conditions make anxiety worse.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 2 Years to 12 Years
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07575815 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort of children ages 2–12 undergoing radiation therapy at MD Anderson Cancer Center. Anxiety will be measured with the Modified Yale Preoperative Anxiety Scale Short Form (mYPAS-SF) at standardized milestones: simulation, first week of treatment, mid-treatment, and final treatment week. The study will also record treatment-related contextual factors such as treatment fraction number, anesthesia use, child-life support, caregiver presence, waiting times of 30 minutes or longer, and time of day to explore associations with observed anxiety patterns. No experimental interventions are given; the goal is to map procedural anxiety trajectories to inform future supportive care strategies.

Who should consider this trial

Good fit: Children aged 2–12 who are scheduled to start radiation therapy at MD Anderson, whose parents can provide signed consent (and assent from children aged 7 and older), and who have not yet completed the simulation session are ideal candidates.

Not a fit: Children outside the 2–12 age range, those already past their simulation session, patients treated at other centers, or those without parental consent/child assent are unlikely to gain benefit from participation.

Why it matters

Potential benefit: If successful, the findings could identify when children are most anxious and which modifiable factors contribute, enabling targeted supports to reduce distress and potentially decrease anesthesia use.

How similar studies have performed: Prior observational studies using the mYPAS in perioperative and procedural settings have documented anxiety patterns and risk factors, but longitudinal trajectories specifically during pediatric radiation therapy are less well characterized.

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.

Where this trial is running

Houston, Texas

• UT MD Anderson — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Susan L McGovern, MD, PHD — UT MD Anderson
• Study coordinator: Susan L McGovern, MD, PHD

Conditions Anxiety; Radiation