A Randomized Controlled Trial of Symptom Screening by Children With Cancer and Feedback to Providers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 345
- 试验地点
- 2
- 主要终点
- SSPedi (Symptom Screening in Pediatrics) Total Scores
研究概览
简要总结
Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application which builds upon the Symptom Screening in Pediatrics Tool (SSPedi) and consists of two components: (1) a symptom screening component centered on SSPedi; and (2) a supportive care clinical practice guideline (CPG) component. This proposal is a randomized controlled trial that compares daily completion of SSPedi via SPARK for 5 days with symptom feedback to healthcare providers compared with standard of care
详细描述
Participants will be children with cancer or hematopoietic stem cell transplantation (HSCT) recipients who are 8-18 years of age and who can understand English, and who are expected to be in hospital or in clinic daily for 5 days. This will be a multi-center RCT in which we will randomize children to either undergo daily symptom screening for 5 days with symptom reports provided to the healthcare team or standard of care. The primary outcome will be the self-reported day 5 total SSPedi score (range 0-60; higher worse). Secondary outcomes will be the day 5 self-reported individual symptom, pain and QoL scores, and documentation of symptoms and provision of interventions for symptoms over the 5 day trial. We will enroll 345 participants over 4 years from 7 Canadian centers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •8 to 18 years of age
- •Diagnosis of cancer or have received or about to receive HSCT
- •Understand English
- •Expected to be in hospital or clinic for 5 day
排除标准
- •illness severity
- •cognitive disability
- •visual impairment
结局指标
主要结局
SSPedi (Symptom Screening in Pediatrics) Total Scores
时间窗: Measure will be completed by all participants at baseline (day 1) and day 5±1 day.
The primary outcome will be the self-reported total SSPedi score on day 5. The total SSPedi score is a validated measure that reflects the total burden of bothersome symptoms experienced. The total score is the sum of each of the 15 items' Likert scores which range from 0 (not at all bothered) to 4 (extremely bothered) to yield a total score that ranges from 0 (no bothersome symptoms) to 60 (worst bothersome symptoms).
次要结局
- Faces Pain Scale-Revised(Measure will be completed by all participants on day 1 (baseline) and day 5±1 day)
- PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module(Measure will be completed by all participants on day 1 (baseline) and day 5±1 day)
- PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module(Measure will be completed by all participants on day 1 (baseline) and day 5±1 day)
- Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom(Measure will be completed by all participants on baseline (day 1) and day 5±1 day.)
- Faces Pain Scale-Revised(Measure will be completed by all participants on day 1 (baseline) and day 5±1 day)
研究者
Lillian Sung
Pediatric Oncologist
The Hospital for Sick Children