Defining Symptom Trajectories to Inform Risk-Stratified Approaches to Symptom Management in Children With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 228
- 试验地点
- 5
- 主要终点
- Change in Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE)
研究概览
简要总结
The goal of this observational study is to understand how cancer makes children feel over time. The main things the researchers hope to learn are:
- When and how often do children have different feelings or sickness;
- Why do these feelings happen; and,
- How these feelings change a child's overall health.
Participants will answer simple surveys about their health.
详细描述
The use of conventional and novel therapeutics to treat children with advanced cancer leads to burdensome physical and psychological symptoms. Advanced cancer is metastatic upon initial diagnosis, relapsed, progressed, or refractory to treatment, resulting in an uncertain and prolonged disease course. Symptom burden and associated suffering are amplified for these children due to disease burden, intense therapy, and often lengthy treatment. Symptom patterns (trajectories) have been identified in children diagnosed with early-stage cancer, but research characterizing symptom patterns over time in the understudied patient population of children with advanced cancer is sparse.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children:
- •Aged 8-18 years
- •Diagnosis of advanced cancer of any type made by the hematology, oncology, or cellular therapy team
- •Undergoing cancer treatment or comfort care
- •Be English or Spanish literate
- •Inclusion Criteria - Caregivers:
- •Aged >18
- •Caregiver of a child diagnosed with advanced cancer
- •English or Spanish literate
- •Identified as being substantially involved in caring for the child
排除标准
- •Any condition that would prevent participants from completing surveys
研究组 & 干预措施
Children with advanced cancer
干预措施: Health surveys (Other)
结局指标
主要结局
Change in Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE)
时间窗: Baseline, bi-weekly for 4 months
Ped-PRO-CTCAE evaluates pediatric cancer symptoms using patient or caregiver reports scored on a 0-to-3 scale across attributes like frequency, severity, and interference. 38 items are scored 0-3, where 0 = never (or equivalent) and 3 = all the time (or equivalent). Scores range from 0 to 114, with higher scores indicating worse symptoms. This score will be used to measure the trajectory of symptoms over time.
次要结局
- Change in PROMIS Pediatric Global Health 7(Baseline, bi-weekly for 4 months)
- Change in PROMIS Pediatric Mobility - Short Form 7a(Baseline, bi-weekly for 4 months)
- Change in PROMIS Pediatric Physical Stress Experiences - Short Form 8a(Baseline, bi-weekly for 4 months)