Social Inequalities in the Participation and Activity in Children and Adolescents With Hodgkin-lymphoma. A Prospective Multicenter Cohort Study of Social and Personal Influencing Factors
试验速览
- 阶段
- 不适用
- 入组人数
- 700
- 主要终点
- Social participation
研究概览
简要总结
Purpose of this study is to determine the influence of social factors on participation and activity among children and adolescents aged 10-18 years with hodgkin-lymphoma. Furthermore personal and treatment-related factors and their impact on participation will be explored.
详细描述
Hodgkin-lymphoma is a rare malignancy among children and adolescents (about 140 each year in Germany) which is highly curable. Beside this therapeutic success, a lot of therapy-related long-term problems arise (e.g. fertility disorders, thyroid diseases, secondary malignancies). While most of the studies focused on mental and physical impairments, little attention has been drawn to social dimensions of health. Due to the disease and the requirements of the therapy, participation of children with hodgkin-lymphoma can be impaired acutely or chronically. This can be of serious consequences, because participation in daily life is an important component of the development of children and adolescents. To determine the influence of social, personal and treatment-related factors on participation, all patients who were actual treated in the international therapy study EuroNet-PHL-C2 in all of Germany (N ≈ 700) and their parents will be interviewed. Statistical analyses will be done using descriptive and multivariate methods taking account of treatment-related issues (e.g. stage of disease, chemotherapy, radiotherapy, progression/relapse).
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
- •histologically confirmed primary diagnosis of classical Hodgkin's Lymphoma
- •10-18 years
- •written informed consent of the patient and/or the patient's parents or guardian according to national laws
排除标准
- •other (simultaneous) malignancies
结局指标
主要结局
Social participation
时间窗: one month after diagnosis until two years
The Child and Adolescent Scale of Participation, CASP
Quality of life
时间窗: one month after diagnosis until two years
Questionnaire to assess Health Related Quality of Life in chronically ill Children and Adolescents, KINDL
次要结局
- Understanding of illness(one month after diagnosis until two years)
- Autonomy(one month after diagnosis until two years)
- Satisfaction with treatment(one month after diagnosis until two years)
- Social support(one month after diagnosis until two years)
- Self-efficacy(one month after diagnosis until two years)
- Optimism(one month after diagnosis until two years)
- Coping(one month after diagnosis until two years)
- Sense of coherence(one month after diagnosis until two years)
- Behavioural disorders and strengths(one month after diagnosis until two years)
- Fatigue(one month after diagnosis until two years)
研究者
Julia Roick
MSc
Martin-Luther-Universität Halle-Wittenberg