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临床试验/NCT03675997
NCT03675997已完成不适用

GRAFted Patients' anxieTY Report (GRAFTY)

Institut de Cancérologie de la Loire1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Anxiety and depression measure

研究概览

简要总结

Autograft is a technique requiring several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. In this study, level of anxiety will be reported weekly throughout hospitalizations for autologous transplant, to detect the most stressful period.

详细描述

Autograft is one of hematological malignancies treatment, such as lymphoma and myeloma. This technique requires several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. According to the medical and scientific report of the Biomedicine Agency in 2016, 3 043 patients were involved in an autologous transplant, which represents a significant number of patients potentially exposed to these types of anxiety.

That is why it will be interesting in this study to report weekly the level of anxiety throughout their hospitalization for the autologous transplant, to detect the most stressful period.

A validated questionnaire will be used: the HAD (Hospital Anxiety and Depression) scale of anxiety and depression.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Autograft indication according to the Multidisciplinary Concertation Meeting

排除标准

  • Incapacity to complete surveys

结局指标

主要结局

Anxiety and depression measure

时间窗: 30 days

The aim of this study is to measure patients anxiety and depression, using the HAD : Hospital Anxiety and Depression scale. Scores of the HAD scale can be defined as: * By adding the points of the answers: 1, 3, 5, 7, 9, 11, 13: we obtain the "Total A" which corresponds to the measure of the anxiety, then: * 7 or less: absence of symptomatology; * 8 to 10: doubtful symptomatology; * 11 and above: certain symptomatology. * By adding the points of the answers: 2, 4, 6, 8, 10, 12, 14: we obtain the "Total B" which corresponds to the measure of the depression, then: * 7 or less: absence of symptomatology; * 8 to 10: doubtful symptomatology; * 11 and above: certain symptomatology. The minimal score is 0 and the maximal total score is 42.

次要结局

未报告次要终点

研究者

发起方
Institut de Cancérologie de la Loire
申办方类型
Other
责任方
Sponsor

研究点 (1)

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