跳至主要内容
临床试验/NCT04422730
NCT04422730已完成不适用

Evolution of Body Connection and Identity Post-surgery: The Pancreas Cancer Case

Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2020年6月30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
129
试验地点
1
主要终点
comparaison of quality of life score between 4 groups

研究概览

简要总结

Evaluation of psychological impact of patients after pancreatectomy because of cancer diagnosis. Patients will be evaluated with questionnaires after and before intervention. 3 control groups will be used to compare de psychological impact.

研究设计

研究类型
Observational
观察模型
Case Control
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
否

入选标准

  • •Patient is older than 18 years old
  • •With a good understanding and practice of the French language
  • •And depending on the group, experimental or control, presenting:
  • •pancreatic cancer expected to be treated with pancreatectomy or planned to be treated with pancreatectomy excluding cancer or breast cancer scheduled to be treated with mastectomy or acute leukaemia at a recent diagnosis (21 days).
  • •No patient's opposition to the information provided
  • •Affiliated to the social security plan or beneficiary

排除标准

  • •Other medical or psychiatric condition,
  • •Level of cognitive efficiency incompatible with response to questions about himself,
  • •A person in an emergency situation, a person under legal protection or unable to express the non opposition to their participation to research.

结局指标

主要结局

comparaison of quality of life score between 4 groups

时间窗: 12 months

score from 0 to 60

comparaison of Test IES-R score between 4 groups

时间窗: 12 months

score from 0 to100

comparaison of Hospital Anxiety and Dépression score between 4 groups

时间窗: 12 months

score from 0 to 21

comparaison of psychological interview between 4 groups

时间窗: 12 months

measured by an psychologist interpretation

comparaison of Scale of Body Connection score between 4 groups

时间窗: 12 months

score from 0 to 5

次要结局

未报告次要终点

研究者

发起方
Institut Paoli-Calmettes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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