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NCT Number: NCT07575815

Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort

This is a prospective, observational cohort study of pediatric patients ages 2-12 undergoing radiation therapy at MD Anderson Cancer Center.

Recruiting

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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UT MD Anderson

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Susan L McGovern, MD, PHD

CONTACT

[email protected]

713-563-2336

Susan L McGovern, MD, PHD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Susan L McGovern, MD, PHD

CONTACT

[email protected]

(713) 563-2336

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
May 8, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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