Embedded Model of Integrated Paediatric Palliative Care in Paediatric Oncology: Development and Testing its Effectiveness. (EMANCIPATION Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Feasibility and preliminary impact of a structured pediatric palliative care intervention on symptom burden and health-related quality of life in children with cancer
研究概览
简要总结
This sub-study WP9 aims to evaluate the feasibility and preliminary impact of integrating a structured pediatric palliative care intervention into routine oncology care for children with cancer. Using a non randomized controlled design with an interrupted time series approach, the study compares standard oncology care with an intervention comprising symptom management by a palliative nurse psychosocial support by a psychologist and use of validated assessment tools PQ MSAS and PedsQL 3.0 at baseline 4 weeks and 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Intervention Group 1 Children aged 2 to 18 years with cancer 2 Receiving care at participating hospitals 3 Eligible for palliative care as per treating team 4 Primary caregiver willing to consent and participate 5 Able to complete assessments at baseline 4 and 8 weeks Comparator Group 1 Children aged 2-18 years with cancer 2 Receiving routine oncology care without palliative care 3 Caregiver willing to participate and complete follow up.
排除标准
- •Intervention Group
- •Severe cognitive or developmental issues
- •Expected survival less then 4 weeks
- •Language barriers preventing tool use
- •Already receiving structured palliative care
- •Cognitive limitations
- •Language or logistical barriers
- •Caregiver not consenting or non-adherent to follow-up.
结局指标
主要结局
Feasibility and preliminary impact of a structured pediatric palliative care intervention on symptom burden and health-related quality of life in children with cancer
时间窗: Outcomes will be assessed at three time points baseline preintervention 4 weeks mid intervention and 8 weeks post intervention.
次要结局
未报告次要终点
研究者
Dr Naveen Salins
Kasturba Medical College, Manipal University