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临床试验/NCT03686592
NCT03686592已完成不适用

Psychological Effect of the pancréatectomy: a Feeling of Strangeness

Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Measurement of body awareness

研究概览

简要总结

The cancer of the pancreas represents 1,8 % of cancers in France, with 9040 new cases in 2011 (France). This cancer is known to be of dark forecast. Indeed, of late clinical expression, is diagnosed most of the time at a late stage . For that reason, the cancer of the pancreas is considered as the one who presents the least good prognosis for survival. He affects more frequently the men than the women (rate of incidence of 7,7 against 4,7 cases for 100 000). Between 1980 and 2005, the incidence increased by 3,8 % at the women, by 2,0 % at the men (INCA Source, on 2012). The number of cases of cancer of the pancreas in the world is estimated at 278 684, with 266 669 deaths a year (Cancer Incidence and Mortality Worldwide - Globocan, on 2008).

In these cases of very grave cancers, the surgery represents the unique treatment to curative aim, although always not warning of a risk of relapse, and susceptible of entrainer to complications. Thus the pancréatectomy establishes a modality of specific treatment. Remaining the ultimate chance of cure, it is only rarely possible. Indeed, only 10 in 20 % of the cancers of the pancreas exocrines can be handled by surgery when the latter establish 95 % of the cases of pancreatic cancer.

To date, the psychosomatic approach goes away from the search for the causes to be interested more and more in the psychological consequences of the somatic disorders, what we wish to study in the present search.

Once the surgical indication was put, one of the key elements in the psychological plan is the uncertainty as for the outcome of the ablation, as well as the consequences psychopathologiques which ensue from it. The mutilation of an organ, whatever it is, can have an impact on the identity of the person constituting at the same time a physical and narcissistic wound, while having psychological effect at the sick person such as of the anxiety, a depression, or another a state of post-traumatic stress.

More exactly, a study was able to show a positive relation between cancer of the pancreas and depression in a retrospective study. A review of literature concerning the specific relations between depression and cancer of the pancreas was also realized. Besides, 50 % of the patients have a significant level of anxiety and 15 % of depression. A study was nevertheless able to bring to light that the depression does not affect the survival of the patient. Finally, a study was also able to find a decrease marked with the quality of life of the patients during the next first 6 months the operation.

Various studies so studied the quality of life of the patients reached of a cancer of the pancreas in particular in comment surgery. It is also advisable to specify that besides the depression and the quality of life, the strategies of adaptation of the patients having undergone a pancréatectomy were also the object of studies. However, none documented, to date, the specific psychological consequences described clinically by certain patients, in particular the feeling of confusion and strangeness felt, and it in association with the possible presence of a state of post-traumatic stress in several weeks of the operation.

详细描述

The objective of this exploratory research is to identify and to describe the psychological specificities of the pancréatectomy which can in particular include the feeling of strangeness and confusion at the sick person towards its own body.

It will also be a question of estimating the relations of this experience with a possible state of post-traumatic stress. Indeed, the announcement of the cancer as well as the surgery in itself are two elements which can be considered as traumatic.

For it a double methodology will be used, with a design cross-sectionnal: a quantitative shutter(sector) (auto-questionnaires) allowing to study aspects of the psychosocial functioning, and qualitative shutter with a semi-structured interview concerning the subjective experience of the participants. For the interpretation of the meditative data of the conversations, we shall use the phenomenological interpretative analysis ( IPA) which will allow us to investigate in a comprehensive way the subjective experience of the participants by studying the way the people give meaning to the fact that they live.

研究设计

研究类型
Interventional
分配方式
Non 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
是

入选标准

  • •Patient of at least 18 years, presenting a good understanding and a practice of the French language,
  • •Having undergone a pancreatectomy (pancreatic cancer),
  • •Signed Consent of participation,
  • •Affiliating to a national social security or beneficiary of such regimen

排除标准

  • •Other medical or psychiatric affection,
  • •Level of incompatible cognitive efficiency with the answer to auto-questionnaires,
  • •Patient in emergency situation, major person being the object of a legal protective measure (major under guardianship, guardianship or protection(saving) of justice), or outside state to express its consent.

研究组 & 干预措施

pancreatectomized patients

Experimental

Patients with pancreatic cancer who underwent a pancreatectomy at Institut Paoli Calmettes

干预措施: Measurement of body awareness (Other)

Volunteers

Active Comparator

干预措施: Measurement of body awareness (Other)

结局指标

主要结局

Measurement of body awareness

时间窗: 1 day

body awareness will be measured thanks to a scale of Body Connection questionnaire

次要结局

  • Evaluation of post-traumatic stress(1 day)

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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