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临床试验/NCT03844347
NCT03844347终止不适用

Well-being and Stress Control After Colorectal Surgery

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2019年10月21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
154
试验地点
2
主要终点
Functional Assessment of Cancer Therapy Colorectal

研究概览

简要总结

The criteria usually considered to evaluate the quality of life are the presence or absence of a stomy, alteration of the transit or the sexual dysfunctions. Quality of life has been improved by introducing an Enhanced Postoperative Rehabilitation Program After Surgery (ERAS). It is a multidisciplinary medical and paramedical care aimed at minimizing the sources of stress allowing a significant reduction in postoperative complications and length of stay.

However, the emotional feelings of patients, their fatigue, the quality of their relationships with others and their experience of the disease are not usually considered. Nevertheless, these criteria influence the quality of life and constitute the fundamental bases of the psychological well-being, essential in the recovery processes.

We propose to enrich the ERAS program by introducing an individualized support of well-being and stress management aimed at increasing the quality of life of patients. The purpose is to make the patient more autonomous by allowing him/her, to implement stress management exercises.

The main goal of the project is to improve the psychological well-being of patients operated on for colorectal cancer by offering stress management sessions in order to promote postoperative rehabilitation.

The secondary objectives are to demonstrate the impact of stress management sessions on the length of stay and to study the link between the efficiency of these sessions and the quality of life of patients before the surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • Patient undergoing colorectal cancer surgery
  • Regulated surgery
  • With or without radiation treatment and / or preoperative chemotherapy.
  • Patient benefiting from a social protection scheme

排除标准

  • -- Limitation of linguistic or cognitive abilities interfering with the understanding of the study protocol
  • Absence of the consent form of the study
  • Emergency surgery
  • Stomy closure
  • Patient diagnosed psychotic.
  • Patient with "psychiatric disorder" left to the discretion of the investigator

结局指标

主要结局

Functional Assessment of Cancer Therapy Colorectal

时间窗: 5 days after surgery (the day of hospital leaving)

The general well-being questionnaire (FACTC), validated with patients with colorectal cancer, which will allow us to measure the subjective feelings (physical, emotional and social well-being) of patients before hospitalization and on leaving the hospital

Manifestations of Psychological Well-being Measurement

时间窗: 5 days after surgery (the day of hospital leaving)

Patient general quality of life measurement

次要结局

  • Pain assessment(1 day after surgery up to 5 days after surgery (the day of hospital leaving))
  • Fatigue measure(1 day after surgery up to 5 days after surgery (the day of hospital leaving))
  • Sleep quality assessment(1 day after surgery up to 5 days after surgery (the day of hospital leaving))
  • Physical activity evaluation(1 day after surgery up to 5 days after surgery (the day of hospital leaving))

研究者

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

研究点 (2)

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