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临床试验/NCT01922635
NCT01922635终止不适用

Validation of Metrological Properties of Questionnaire of Quality of Life LYMPHOQOL

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
37
试验地点
2
主要终点
Validation of the metrological properties of questionnaire of quality of life LYMPHOQOL

研究概览

简要总结

The constitutional lymphœdema is a rare disease with an annual incidence before the age of 20 years considered at 1,15/100 000. This chronic, incurable disease without hiring directly the prognosis for survival, alter the body image imposing a "visible" deformity and of which the treatment which aims at reducing and at stabilizing the physical deformation is binding and expensive. The lymphœdema is a crippling disease of the child. As such, it rings on the everyday life of the child and on the family environment. This question is all the more important, that all the studies show that the success of the treatment bases on the compliance in the concentration and in the care of hygiene. The parameters of the success of these treatments at the child are not known.

详细描述

In the literature we find no specific information on the psychic and social repercussions of the lymphœdema for the child who is affected. If the psychic and social repercussions of the secondary lymphœdema in the breast cancer are well known, very few things are it on those of the primary lymphœdema. Some studies estimate globally the quality of life of the patients with a lymphœdema whatever is the origin and the etiologie. These studies of money groups suggest that the psychic difficulties and of therapeutic care are not identical. A single study approaches the specific question of the lymphœdema of the child by focusing on the real-life experience of expanding child of a primary lymphœdema.The construction and the validation of a tool measuring the quality of life of the children and the young adults affected by lymphœdema congenital appears as a starting point. A tool which would first of all allow to make the current situation for the regional level, and then can envisage national actions common. According to recent studies, the evolution of the lymphoedema is different according to the forms of initial clinical expression of the lymphoedema, we wish we can thus know during this study the impact of these various clinical forms on the quality of life of the patients. A genetic collection will be realized for that purpose (genetic research).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Primary lymphedema, stage 2 or 3 ISL

排除标准

  • Primary lymphedema stage 1, secondary lymphedema, Minimum 6 years, maximum 25

结局指标

主要结局

Validation of the metrological properties of questionnaire of quality of life LYMPHOQOL

时间窗: 3 Years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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