Improving Quality of Life of Children With Cancer Through Psychosocial Screening and Improved Communication in Health Care Providers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 3
- 主要终点
- Change from baseline psychological distress at pediatric cancer diagnosis to six months later
研究概览
简要总结
In Canada, approximately 1450 children are diagnosed with cancer annually. Diagnosis of childhood cancer and its aggressive treatment can have devastating psychosocial effects on the whole family (e.g. unpleasant feelings or emotions that impact your daily activities). It is not known whether health care providers who treat these children use and value psychosocial tools or how beneficial the use of these tools is for these families. This research team will test the benefits of using psychosocial screening on the quality of life of treated children, parents and siblings.
详细描述
In Canada approximately 1450 children are diagnosed with cancer annually. Childhood cancer diagnosis and treatment can have devastating psychosocial effects on the family. Tools to screen for psychosocial risks (PSR) in pediatric oncology are rare. Our preliminary work adapted the Psychosocial Assessment Tool (PAT) for the Canadian population, PATrevised (PATrev), and developed the Psychosocial Care Checklist (PCCL). The PATrev is completed by parents of children with cancer, and yields a summary of the psychosocial needs of the patient, parents, and siblings. The PCCL assesses HCPs knowledge of family's psychosocial needs and services. Importantly, psychosocial screening is associated with reduced parental anxiety and improved child's quality of life (QOL). Demonstration of the tool's ability to maximize patient and family psychosocial outcomes is needed. Participants will be parents of children newly diagnosed with cancer, (patients and siblings (> 8 years), if available). Design: RCT with concealed allocation to experimental group (EG) and control group (CG), with repeated measures (after diagnosis= T1, 6 months later=T2). The EG treating team will receive a summary of PATrev risk information based on parent report. No risk information will be provided in the CG. Parents in both groups will complete the PATrev, family environment questionnaire, self--report and proxy reported QoL, distress and mood measures for the patient and one sibling. Patients and siblings will self-report on QOL, distress and mood. Patient charts will be reviewed (T2) to determine treatment intensity and documented psychosocial services for each family.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents of children newly diagnosed with cancer, within 2 to 4 weeks post-diagnosis.
- •Siblings of children newly diagnosed with cancer, within 2-4 weeks post-diagnosis, between the ages of 8 years and 16 years, able to complete outcome measures, without a physical chronic condition.
- •Children with cancer, newly diagnosed, within 2 to 4 weeks post-diagnosis, between the ages of 8 and 16 years, able to complete outcome measures.
排除标准
- •Parents of children not diagnosed with cancer.
- •Sibling of children not diagnosed with cancer
- •Children not diagnosed with cancer.
结局指标
主要结局
Change from baseline psychological distress at pediatric cancer diagnosis to six months later
时间窗: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Measured by Hospital Anxiety and Depression Scale (HADS). A standardized measure of symptoms of anxiety and depression in adults. The HADS is suitable for all ages from 17+. The HADS consists of 14 questions, which are ranked according to a 4 point Likert type scale.
次要结局
- Change from baseline distress at pediatric cancer diagnosis to six months following(T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis))
- Change from baseline quality of life at pediatric cancer diagnosis to six months (Parent Self-Report)(T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis))
- Change from baseline family climate at pediatric cancer diagnosis to six months(T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis))
- Change from baseline quality of life at pediatric cancer diagnosis to six months (Self) report(T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis))
- Change from baseline quality of life at pediatric cancer diagnosis to six months (Proxy Report)(T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis))
- Pediatric Distress Thermometer(T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis))
- Pediatric Index of Emotional Distress (PI-ed)(T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis))
研究者
Maru Barrera
Psychologist
The Hospital for Sick Children