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
- 1
- 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
研究组 & 干预措施
SPARK Intervention
Participants will complete symptom screening using SPARK once daily on a study-supplied iPad. For inpatients, daily reminders to complete SSPedi will appear on the iPad. Reports will be available to the child at any time. For outpatients, clinical research associates will provide the iPad in person daily and reports may be viewed at those encounters. The intervention is daily symptom screening with provision of reports to the healthcare team. Severe symptoms will result in email alerts. More specifically, SSPedi reports will be printed daily and provided in the patient chart. On days 1 and 3, an alert will be emailed to the physician providing direct medical care if any symptom is "a lot" or "extremely" bothersome (score 3 or 4 on 0-4 scale). Reports and alerts will have links to SPARK-housed CPGs.
干预措施: SPARK (Other)
Standard of Care Arm
Participants randomized to the control arm will not complete daily symptom screening. They will complete SSPedi on days 1 and 5 to obtain the primary outcome. Health care providers will not be notified of their SSPedi scores and no symptom reports or symptom alerts will be generated.
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)
- 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)
- 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)
研究者
Lillian Sung
Pediatric Oncologist
The Hospital for Sick Children