Refinement and Early Evaluation of SPARK, an Approach to Enable Symptom Screening and Monitoring by Children Receiving Cancer Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of an RCT of symptom feedback to healthcare providers versus standard of care
研究概览
简要总结
Children with cancer and hematopoietic stem cell transplant (HSCT) recipients suffer from severe and bothersome symptoms because treatments are intense. So, the investigators developed SPARK (Supportive care Prioritization, Assessment and Recommendations for Kids), a website devoted to helping children track symptoms and providing a way to let doctors and nurses know which symptoms are bothersome. This study will examine the likelihood that children will complete SPARK once daily, help the investigators figure out how to improve the website so that children will use it, and help the investigators plan the large scale trial to test its efficacy in improving quality of life (QoL).
Participants will be children with cancer or HSCT recipients who are 8-18 years of age and who are expected to be in hospital or in clinic daily for 5 days.To determine the feasibility of a randomized controlled trial (RCT) of symptom feedback to healthcare providers
详细描述
Methods: Participants will be children with cancer or 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.
SPARK RCT will be a pilot 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. Feasibility will be met if at least 30 participants are enrolled within one year and at least 75% complete at least 60% of evaluations.
Quality of the Idea Children receiving cancer treatment have excellent survival outcomes, in part, related to the provision of intensive therapies. Unfortunately, most children suffer and experience severe and bothersome treatment-related symptoms. Symptoms not only impact on QoL and morbidity but, in addition, may negatively influence future psychosocial functioning.
Symptoms remain unaddressed even during healthcare encounters because children do not complain and clinicians fail to ask about them. We recently developed SSPedi, a pediatric-specific symptom screening tool on an iPad. SSPedi, however, consists only of the questions which ask about symptoms. SPARK is the web-based application which will facilitate access to SSPedi, encourage symptom screening, generate reports and allow children to track their symptoms. Careful thought to design is required to ensure SPARK optimizes future use and has clinical utility. The proposed project output is a product that facilitates longitudinal symptom screening and provides the groundwork for a future RCT of symptom feedback.
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
- •We will include children with cancer and HSCT recipients who are 8-18 years of age at enrollment and who can understand English.
- •Participants may be inpatients or outpatients, and may be actively receiving cancer treatment or may have completed treatment.
排除标准
- •Exclusion criteria will be illness severity, cognitive disability, or visual impairment that precludes utilization of SPARK according to the healthcare team.
结局指标
主要结局
Feasibility of an RCT of symptom feedback to healthcare providers versus standard of care
时间窗: Study will be enrolling for 1 year with a goal to enroll 30 participants. Feasibility will be determined once all 30 participants have completed the study after 1 year
Will be determined by both the number of patients who are recruited for this study, and the number of patients who complete at least 60% of evaluations. We will aim to enroll 30 participants at SickKids over one year. Outcome feasibility will be met if at least 30 participants are enrolled within one year and at least 75% complete at least 60% of evaluations
次要结局
- Pediatric Quality of Life (Peds QL) Cancer Module Acute Version(Measure will be completed by participant on day 5±1 day.)
- Symptom Screening in Pediatrics (SSPedi)(Those randomized to the intervention arm measure will be completed by participant every day for 5 days. Those randomized to control arm measure will be completed by participant on Days 1 and 5±1 day.)
- Faces Pain Scale Revised(Measure will be completed on day 5±1 day.)
研究者
Lillian Sung
Pediatric Oncologist
The Hospital for Sick Children