Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort

M.D. Anderson Cancer Center20 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anxiety Radiation

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

UT MD Anderson

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame: Through study completion; an average of 1 year.

Central Contacts

Susan L McGovern, MD, PHD

CONTACT

(713) 563-2336 slmcgove@mdanderson.org

Data from ClinicalTrials.gov

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