NCT07575815招募中不适用
Baseline Anxiety Trajectories in Pediatric Radiation Therapy Observational Cohort
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
This is a prospective, observational cohort study of pediatric patients ages 2-12 undergoing radiation therapy at MD Anderson Cancer Center.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
研究点 (1)
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