Facilitating Early Integration of Palliative Care in Pediatric Oncology: Development and Implementation of a Nurse-initiated Conversation Program for Pediatric Cancer Patients and Their Families
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Scores of children's quality of life
研究概览
简要总结
This study aims to develop and implement a pediatric palliative care (PPC) program. It is an open-label, randomized trial (2:1 randomization) in pediatric oncology department of Children's Hospital of Fudan University. The intervention group will receive Nurse-initiated Conversations for Early Integration of Palliative Care in Pediatric Oncology (NiCE). The control group will receive routine PPC (will be scheduled to meet with the PPC team only when participants themselves, their families, or the attending oncologist requested an appointment). The intervention will take 6 months.
详细描述
Early integration of PPC, endorsed by a number of international societies, is well supported by evidence on providing multi-layer relief in children and their families over the course of any life-threatening illness. This study will leverage oncology nurses' role, culturally adapt the well-recognized St. Jude Children's Individualized Care Planning and Coordination (ICPC) Model to develop and evaluate a nurse-initiated conversation program to facilitate early integration of palliative care in pediatric oncology care.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children within eight weeks of initial oncologic diagnosis or within eight weeks of relapse/recurrent disease diagnosis
- •Children speaking Chinese
- •Children's family caregivers accompanying the child in the hospital (only one family member is eligible to take this role under current hospital policy)
- •Children's family caregivers speaking Chinese
- •Health care providers who are taking care of the eligible children, including but not limited to physicians, nurses, and social workers
排除标准
- •Children who, in the opinion of their physician, are not capable mentally or verbally of participating in the survey or interview
结局指标
主要结局
Scores of children's quality of life
时间窗: Measured every three months over six months.
Scores of children's quality of life will be measured by Peds Quality of Life TM4.0 scale. It encompasses four subscales: physical, emotional, social and school functioning. It asks how much of a problem each item has been during the past month. It comprised of parallel child self-report and parent proxy-report formats. Child self-report includes ages 5-7 years (young child), ages 8-12 years (child), and ages 13-18 years (adolescent). All items use a five-point Likert response set range from 'never' to 'almost always'. Items are reverse-scored and linear-early transformed to a scale of 0 to 100 (0 = 100, 1= 75, 2= 50, 3= 25, 4=0), so that higher scores indicate a better quality of life. It is a repeated measurement, will be measured at baseline, three months and six months, for three times.
次要结局
- Scores of children's family caregivers' care burden(Measured every three months over six months.)
- Scores of children's family caregivers' anxiety(Measured every three months over six months.)
- Scores of children's family caregivers' depression(Measured every three months over six months.)
- Appropriateness of the NiCE intervention(At the sixth month of the study.)
- Scores of children's mobility(Measured every three months over six months.)
- Acceptability of the NiCE intervention(At the sixth month of the study.)
- Incidence of adverse events(Measured every four weeks over six months.)
- Feasibility of the NiCE intervention(At the sixth month of the study.)
- Barriers and facilitators(At the sixth month of the study.)