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临床试验/NCT03306693
NCT03306693终止不适用

Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers as Compared to Standard Management

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
23
试验地点
1
主要终点
Change in patient emotional skills from baseline to 15 days after intervention

研究概览

简要总结

The aim of this study is to test whether a short educational intervention about emotional skills can improve survivor cancer patient emotional skills and quality of life. Half of participants will follow the educational intervention about emotional skills, while the other half will practice relaxation followed by a non-directive talking group. The educational intervention should give better results on patient emotional skills and quality of life than the control group.

详细描述

After the end of treatments, cancer patients face a difficult time because it is expected that they return to normal, but at the same time they still have to struggle with the aftermath of cancer and fear of recurrence. This is why there is room in this period for an intervention designed to help patients to cope with their emotions. . Patient emotional skills are patient abilities to identify, express and manage their emotions for the best possible psychological adjustment. In general population, emotional skills have been shown to be highly related to a better quality of life. In this randomized controlled study, bronchopulmonary and oesogastric cancer patients between 6 months and 2 years after the end of treatments will undergo either the emotional skills intervention (intervention group) or the relaxation group (control group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Oesogastric or bronchopulmonary cancer patients between 6 months and 2 years after the end of cancer treatments
  • Patient of the CHRU (Regional Teaching Hospital) of Lille,
  • Registered with a social security scheme
  • Speak and understand French language
  • Signature of the informed consent to participate in the study.

排除标准

  • Cognitive disorders or unstabilized psychiatric disorders that may impair the ability of reasoning and thinking necessary to complete the questionnaires and attend workshops
  • Difficulty or deficiency that prevent the patient from a good understanding of the imperatives of the research
  • Any situation likely to significantly affect emotional competence during the study according to the investigator's judgment (in particular, ongoing psychotherapy )
  • Patients under judicial protection (guardianship or curators).

结局指标

主要结局

Change in patient emotional skills from baseline to 15 days after intervention

时间窗: Baseline and 15 days after the end of the intervention

Variation of patient-reported Short Profile of Emotional Competence (S-PEC)questionnaire score from baseline to 15 days after the intervention (between 1 and 3 months)

次要结局

  • Patient adherence to exercises to do at home between sessions(Between 2 weeks and 2 months)
  • Patient participation in workshops(Between 2 weeks and 2 months)
  • Patient emotional skills long term(T1 (15 days after the end of the intervention) and T2 (2 months after T1) : 2 months)
  • Patient satisfaction(T1 (15 days after the end of the intervention) and T2 (2 months after T1))
  • Quality of life by Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)(Baseline (T0), 15 days after the end of the intervention (T1), 2 months)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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