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Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort

NCT07575815 · M.D. Anderson Cancer Center
In plain English

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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
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.
Study design
Enrollment target: 20 participants
Age groups: child
Timeline
Starts: 2026-05-06
Estimated completion: 2029-03-01
Last updated: 2026-05-11
Primary outcomes
  • Safety and Adverse Events (AEs) (Through study completion; an average of 1 year.)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactSusan L McGovern, MD, PHD · contact · slmcgove@mdanderson.org · (713) 563-2336
InvestigatorSusan L McGovern, MD, PHD · principal_investigator, UT MD Anderson
All locations (1)
UT MD AndersonRecruiting
Houston, Texas, United States
Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort · TrialPath