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临床试验/NCT05293925
NCT05293925已完成不适用

Consultation d'Annonce d'Arrêt de la Chimiothérapie et Des Traitements Spécifiques en Contexte Ambulatoire: évaluation de l'Impact Psychologique et Des échanges d'Informations.

Institut Curie1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Emotions thermometers

研究概览

简要总结

The average 5-year survival rate for patients diagnosed with cancer in France is estimated at 53%. Nearly half of all patients diagnosed with cancer are not alive 5 years after diagnosis Discontinuation of anti-tumor treatments is therefore a major issue in their care. Discussing the discontinuation of specific treatments requires scientific oncological skills but also communication skills. The difficulties encountered by oncologists concerning communication about the end of life are linked to the doctors' personal discomfort with death, their fear of the responsibility of stopping chemotherapy, and their distrust of their colleagues. On the other hand, they may also come from patients who are supposedly reluctant to talk about the end of life, a reluctance that is heightened in the case of language barriers, young age or pressure from families. Finally, the place of practice could explain some of the difficulties in talking about the end of life, notably because of a lack of training in delivering bad news or a stigma attached to palliative care.

This exploratory work should make it possible to describe the characteristics of the announcement of the cessation of anti-tumor treatments in ambulatory patients, to evaluate distress, anxiety, depressive symptomatology, as well as the satisfaction of the patients concerning the management received.

详细描述

In this pilot study, we will describe for the first time the discontinuation of anti-tumour treatments in outpatients with advanced cancer and evaluate the psychological impact on patients following this announcement.

In outpatients patients, these announcements of treatment cessation will be made in a conventional oncology consultation or in Palliative Care Day Hospital.

This exploratory work should make it possible to describe the characteristics of the announcement of the cessation of anti-tumour treatments in ambulatory patients, to assess distress, anxiety, and the depressive symptomatology, as well as patient satisfaction with the treatment received.

The 2 hypotheses of this research work are the following:

  1. the announcement of the cessation of specific treatments can generate distress, anxiety and depressive symptoms for the patient, and may be a source of dissatisfaction with the quality of care received.
  2. the existence of an improvement in the quality of the announcement when it is made in HDJ SP in comparison with an announcement made in a conventional oncology consultation; reduction of the psychological impact for the patient, reduction in markers of aggressiveness of care at the end of end of life care. The doctors involved in this project have received training in listening to and supporting patients with advanced cancer in a palliative situation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 125 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major outpatients with advanced cancer for whom anti-tumour treatment is announced by the oncologist in a conventional oncology consultation or in Palliative Care Day Hospital.
  • Patient who speaks and understands the French language.
  • Patient over 18 years of age.
  • Patient informed and not opposed.

排除标准

  • Refusal of the patient or doctor to participate in the study.
  • Patient does not speak or understand the French language.
  • Patient under 18 years of age.
  • Persons deprived of liberty or under guardianship (including curatorship).
  • Persons of legal age under court protection.
  • Inability to participate in the study for geographical, social or psychological psychological reasons.

结局指标

主要结局

Emotions thermometers

时间窗: Day 7

These thermometers have a scale of 0 to 10 and will indicate the average level of distress, anxiety, depression, anger, and help needed for the past week including the current day. Higher scores mean a worse outcome

次要结局

  • EORTC QLQ PATSAT-C33 (Questions 1 to 10)(Day 7)
  • Hospital Anxiety and Depression Scale (HADS)(Day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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