Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Radiation; Anxiety

Study type: Observational

Funder types: Other

Identifiers

NCT07575815

2026-0247

NCI-2026-03503 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No 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.