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临床试验/NCT04244955
NCT04244955终止不适用

Observational Study Evaluating the Psychic Impact of the Diagnostic Announcement and Care for Children Treated for Cancer

Centre Leon Berard1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
1
主要终点
Analyze of significant psychological difficulties in children aged 6 to 16

研究概览

简要总结

The cancer diagnostic announcement and cancer care are both physical and psychological highlights. The main objective is to analyze significant psychological difficulties in children aged 6 to 16 treated for cancer.

详细描述

Symptoms of post traumatic stress disorder in young children are often underdiagnosed because the criteria of DSM-IV and ICD-10 are not suitable for these children. These symptoms are nightmares, sleep problems, compulsive and joyless gambling, regression, hyper attention, anxiety over new separation, and new fears. It is also known that the disorders are readily more marked at the start of treatment and then subside throughout the first year. Some may appear afterwards after treatment.

To our knowledge, no study has evaluated the prevalence of mental disorders linked to diagnosis and care during treatment and their link with the practice of care. This study will focus on disorders during treatment. We will study the psychic impact of the announcement of diagnosis and care, whether they belong to the traumatic dimension or not. For this, we will use the validated French version of the Child Post-Traumatic Stress Reaction Index (CPTS-RI) scale. It is the most widely used scale in clinical research of trauma and reactive mental disorders in children 6 to 16 years of age. We will also assess the most disturbing elements for the child and the main clinical manifestations found in order to improve the detection of mental disorders and the care support for these children.

This research will allow us to assess the prevalence of mental disorders in connection with the care practiced within the Institute of Pediatric Hematology and Oncology (IHOPe) and, subsequently, to establish a another intervention research protocol to improve our practices and the care of these patients.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient aged 6 to 16 years;
  • Patient diagnosed for a malignant pathology for at least one month and maximum 2 months;
  • Patient treated at the IHOPe;
  • Non-opposition of the parents and the child under study.

排除标准

  • Difficulty speaking and understanding French;
  • Patient who is not able to express himself because the somatic medical conditions do not allow a verbal exchange.

结局指标

主要结局

Analyze of significant psychological difficulties in children aged 6 to 16

时间窗: 30 minutes

Score at the Child Post-Traumatic Stress Reaction Index (CPTS-RI) questionnaire. A score strictly greater than 24 on the CPTS-RI questionnaire will be considered clinically significant for the primary endpoint

次要结局

  • Evaluation of the most disturbing elements for the child and the main clinical manifestations found.(30 minutes)
  • Collection of the opinion of the caregivers (doctors, nurses) of each patient on the psychic impact of care on the child.(30 minutes)
  • Evaluation of the agreement between the levels of difficulty rated by the child and his caregivers.(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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