Symptom Trajectory Approaches to Research (STAR)
2026年9月1日 更新者：University of Wisconsin, Madison
Defining Symptom Trajectories to Inform Risk-Stratified Approaches to Symptom Management in Children With Advanced Cancer
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
228
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Sabrina Cordon-Royer
- 邮箱：cordonroyer@wisc.edu
学习地点
-
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California
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Los Angeles、California、美国、90027
- Children's Hospital Los Angeles
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New York
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New York、New York、美国、10032
- New York -Presbyterian Morgan Stanley Children's Hospital
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Ohio
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Columbus、Ohio、美国、43205
- Nationwide Children's Hospital
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Oregon
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Portland、Oregon、美国、97239
- OHSU Doernbecher Children's Hospital
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Wisconsin
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Madison、Wisconsin、美国、53705
- American Family Children's Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
取样方法
非概率样本
研究人群
Potential participants will be identified through the pediatric hematology/oncology research team and/or clinicians.
描述
Inclusion Criteria - 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
Exclusion Criteria:
- Any condition that would prevent participants from completing surveys
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Children with advanced cancer
|
Participants will complete several surveys about their quality of life and health.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE)
大体时间：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.
|
Baseline, bi-weekly for 4 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in PROMIS Pediatric Global Health 7
大体时间：Baseline, bi-weekly for 4 months
|
PROMIS Pediatric Global Health 7 is a 7-item survey used to measure overall physical, mental, and social health in children and adolescents.
It is scored using a 5-point Likert scale, where 1 = poor and 5 = excellent.
Scores range from 7 to 35, with higher scores indicating better global health.
|
Baseline, bi-weekly for 4 months
|
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Change in PROMIS Pediatric Mobility - Short Form 7a
大体时间：Baseline, bi-weekly for 4 months
|
PROMIS Pediatric Mobility is a 7-item questionnaire that evaluates self-perceived physical mobility and functioning in children and adolescents.
It uses a 5-point Likert scale ranging from "Without no trouble" to "Not able to do".
Raw scores range from 7 to 35.
Raw scores are translated into normalized T-scores with a US population-level mean of 50 and a standard deviation (SD) of 10.
A T-score of 50 represents average mobility for the general population.
Scores above 50 mean better-than-average mobility, while scores below 50 indicate greater impairment.
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Baseline, bi-weekly for 4 months
|
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Change in PROMIS Pediatric Physical Stress Experiences - Short Form 8a
大体时间：Baseline, bi-weekly for 4 months
|
PROMIS Physical Stress Experiences is an 8-item questionnaire designed to measure physical symptoms of stress in children and adolescents.
It is scored by summing the raw item responses (ranging from 8 to 40) and converting that total into a standardized T-score.
The raw score maps to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10 for the general population.
Higher T-scores reflect a greater level of physical stress.
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Baseline, bi-weekly for 4 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Kathleen (Kitty) Montgomery, PhD, RN, PCNS-BC、University of Wisconsin, Madison
- 首席研究员：Kristine Kwekkeboom, PhD, RN, FAAN、University of Wisconsin, Madison
- 首席研究员：Roger Brown, PhD、University of Wisconsin, Madison
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年12月1日
初级完成 (估计的)
2031年5月31日
研究完成 (估计的)
2031年5月31日
研究注册日期
首次提交
2026年9月1日
首先提交符合 QC 标准的
2026年9月1日
首次发布 (实际的)
2026年9月4日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月1日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2026-0259
- UWMSN | Nursing | Administrati (其他标识符：UW Madison)
- 1R01CA307143 (美国 NIH 拨款/合同)
- Protocol Version 2/11/26 (其他标识符：UW Madison)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.