Social Inequalities in the Participation and Activity in Children and Adolescents With Leukemia, Brain Tumors, and Sarcomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Level of quality of life
研究概览
简要总结
Aim of this study is to investigate the influence of social factors on participation and activity among children and adolescents aged 10-18 years with leukemia, brain tumors, and sarcomas. Furthermore personal and treatment-related factors and their impact on participation will be explored
详细描述
Background: About 2000 children and adolescents under the age of 18 develop cancer each year in Germany. Because of more differentiated diagnostics and standardized treatment protocols, a high survival rate can be reached for many types of the disease. Nevertheless, patients face a number of long-term effects related to the treatment. As a result, physical and psychological consequences have increasingly become the focus of research in recent years. Social dimensions of health have rarely been investigated in pediatric oncology so far. Yet, there are no robust results that allow an estimation of whether and to what extent the disease and treatment impair the participation of children and adolescents and which factors mediate this effect. Social participation is of great importance especially because interactions with peers and experiences in different areas of life are essential for the development of children and adolescents.
Methods: Data are collected in a longitudinal, prospective, observational multicenter study. For this purpose, all patients and their parents who are being treated for cancer in one of the participating clinics throughout Germany will be interviewed within the first month after diagnosis (t1), after completion of intensive treatment (t2) and half a year after the end of intensive treatment (t3) using standardized questionnaires. Analysis will be done by descriptive and multivariate methods.
Recruitment: Patients will be consecutively recruited in one of the participating clinics throughout Germany.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed with confirmed leukemia, brain tumor or sarcoma
- •age 10-18 years
- •written informed consent of the patient and of one of the parents if they are under the age of 18
排除标准
- •having a relapse or secondary tumor
- •insufficient command of German
- •profound cognitive and physical impairments
结局指标
主要结局
Level of quality of life
时间窗: Within the first month after diagnosis until half a year after intensive treatment
Questionnaire to assess Health Related Quality of Life in chronically ill Children and Adolescents, KINDL Subscales: physical well-being, emotional well-being, self-esteem, family, friends, school, and a total score Values: range from 0 to 100 (higher values represent better quality of life)
Social participation and activity
时间窗: Within the first month after diagnosis until half a year after intensive treatment
The Child and Adolescent Scale of Participation, CASP
次要结局
- Evaluation of the treatment(End of intensive treatment)
- Illness perception(Within the first month after diagnosis until half a year after intensive treatment)
- Self-efficacy(Within the first month after diagnosis until half a year after intensive treatment)
- Optimism(Within the first month after diagnosis until half a year after intensive treatment)
- Psychosocial problems and strengths(Within the first month after diagnosis until half a year after intensive treatment)
- Sense of coherence(Within the first month after diagnosis until half a year after intensive treatment)
- Self-concept(Within the first month after diagnosis until half a year after intensive treatment)
- Social support(Within the first month after diagnosis until half a year after intensive treatment)
- Fatigue(Within the first month after diagnosis until half a year after intensive treatment)
- Coping(Within the first month after diagnosis until half a year after intensive treatment)
- Mental health(Within the first month after diagnosis until half a year after intensive treatment)
- Autonomy(Within the first month after diagnosis until half a year after intensive treatment)
研究者
Julia Roick
Research Associate
Martin-Luther-Universität Halle-Wittenberg