Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07575815

Enrollment

Registered

2026-05-08

Start date

2026-05-06

Completion date

2029-03-01

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Radiation

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and Adverse Events (AEs)	Through study completion; an average of 1 year.	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Countries

United States

Contacts

CONTACTSusan L McGovern, MD, PHD

slmcgove@mdanderson.org(713) 563-2336

PRINCIPAL_INVESTIGATORSusan L McGovern, MD, PHD

UT MD Anderson

Outcome results