Rehabilitation Including Social Activity and Education in Children and Teenagers With Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Level of educational achievement
研究概览
简要总结
The purpose of this study is to determine whether early rehabilitation intervention including educational and social activities with a class mate at two weeks intervals at the ped.onc. center will increase children with cancer's level of education performance.
详细描述
Background In Denmark 200 children under the age of 18 are diagnosed annually with cancer and the prevalence of patients undergoing anticancer therapy is 300. The expected five-year survival rate is 80%, but since the treatment is intensive with a high risk of life-threatening infections, these patients are frequently isolated at home or in hospital during their 1-2 years of therapy, which means reduced contact with their normal school environment, leisure activities and friends. Long-term survivors of childhood cancer frequently have compromised age-appropriate social relationships and psychosocial development, difficulties with resuming physical activities, and poor self-esteem leading to reduced quality of life. Intervention studies designed to improve physical and social function during treatment of children with cancer are lacking.
Aim To develop an interactive rehabilitation programme that a) preserve the educational, physical and psychosocial life of the patients or even obtains "growth with cancer", b) maintains the child's everyday life (e.g. normal social relationships), and c) improves long-term physical performance, social competences, higher grade educational enrollment, and later integration into the labour market.
Theoretical basis This project is inspired by Erving Goffman's interactional theory on normality and related concepts of stigma and frame analysis as well as Thomas Scheff's theory on the concept of emotional and social bonds and the development of the sociology of emotions.
Material and methods Intervention group: Children aged 6.0-18.0 years diagnosed with cancer 2013-2015 at Rigshospitalet (covers eastern part of Denmark (approximately 50% of total population)).
Control group:
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed with cancer and treated at the pediatric oncology units in Denmark (Rigshospitalet, Odense University hospital, Aarhus University Hospital and Aalborg University Hospital)
- •Children diagnosed with non-malignant diseases treated with surgery, chemotherapy or irradiation similar to cancer (e.g. benign CNS tumors, langerhans cell histiocytosis, Myelodysplastic Syndrome (MDS)) and treated at the pediatric oncology units in Denmark (Rigshospitalet, Odense University hospital, Aarhus University hospital and Aalborg University Hospital).
- •Attend school at the time of diagnosis
- •Able to communicate in Danish
排除标准
- •Mental retardation at the time of diagnosis (including Down syndrome). Terminal illness at the time of diagnoses. Severe co-morbidity.
研究组 & 干预措施
Intervention group
The intervention components includes (real time sequence):
An educational session where the child is educated on his/her cancer disease An education session in the child's school where the child´s teachers, classmates and their parents are educated on the child´s cancer disease.
Appointment of two classmates as "ambassadors" Continued individualized education at the hospital school or at home that parallels/copies the educational curriculum in the child regular school At two weks intervals joined education, physical (separate study) and social activity days at the hospital with together with one of the ambassadors
干预措施: Intervention group (Behavioral)
Standard educational programme
The children receive the standard of care with respect to education this include education in the hospitals school or at home without a class mate and no specific activity to secure continuous linkage with community school and class mates
结局指标
主要结局
Level of educational achievement
时间窗: 1 year after cessation of first-line cancer treatment
The child´s level of education in Danish (1. language and reading) and math is measured on a five point scale including outstanding level of performance, high level of performance, satisfactory level of performance, needs improvement in level of performance, and unsatisfactory level of performance. Maximum 10% of the children in the intervention group receiving the integrated education program with their regular class mate's will experience a decrease of one or more levels on the five point performance scale.
次要结局
- Quality of life(diagnosis, 6 months after diagnoses, 1 year post treatment)
研究者
Kjeld Schmiegelow
Professor
Rigshospitalet, Denmark