Supporting Patient Provider Communication for Children With Cancer and Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Patient-provider communication
研究概览
简要总结
Children with Cancer or congenital heart disease (CHD) experience complex, physical, psychosocial and behavioural symptoms and problems due to the illness, treatment, and medical procedures. To help children cope with their problems and prevent psychological distress, the investigators developed SiSom, a support system to help children with cancer or CHD report their symptoms and problems in an age-adjusted manner on a touch-pad, portable computer.
This quasi-experimental study with 202 children age 7-12 with CHD or cancer will test the following hypotheses: When children use SiSom to report their symptoms and problems, and this information is provided to their clinicians in their outpatient consultations:
- Children and parents will experience less anxiety.
- Children and parents will be more satisfied with the outpatient visit.
- There will be greater congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care.
To better understand the mechanisms by which these effects may occur, the investigators will also explore:
- Differences between control and experimental groups in patient-provider communication in terms of instrumental and affective behaviour, participation, initiative and person addressed;
- The relationships among outcomes of patient-provider communication, congruence between patients' reported symptoms and those addressed by their clinicians and children's and parents' anxiety and satisfaction; and how these relationships differ between treatment and control conditions.
Finally, the investigators will investigate time requirements, ease of use and usefulness of SiSom by children and clinicians.
For analyses the investigators will use inferential statistics and qualitative analyses of the video-taped consultation sessions. This study will contribute to improving patient-centred care for a particularly vulnerable population, and to a better understanding of the triadic communication and interactions among child-parent and clinician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 7 and 12 years.
- •Ethnic norwegian.
- •Undergoing treatment for cancer or diagnosed with a congenital heart disease.
排除标准
- •Receiving or have received radiation the brain as this may affect their abilities to use SiSom and communicate during consultations.
- •Syndromes, mental retardation, developmental disorders, language disorders, or cognitive disorders that affect their ability to report symptoms or communicate during consultations.
- •Other ethnic origin.
结局指标
主要结局
Patient-provider communication
时间窗: Single measure, video recording of medical consultation lasting approximately one hour
次要结局
- State anxiety(10 minutes pre and 10 minutes post intervention)
- Patient-provider communication(Single measure, video recording of medical consultation lasting approximately one hour)
- Time requirements, ease of use(Single measure, after collection of all patient data)
- Congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care.(Single measure, ten minutes post intervention)
研究者
Cornelia Ruland
Professor
Oslo University Hospital