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Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort

Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort

Recruiting
2-12 years
All
Phase N/A

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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.

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

Eligibility

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 details
    Anxiety
    Radiation

NCT07575815

M.D. Anderson Cancer Center

13 May 2026

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