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临床试验/NCT02896790
NCT02896790已完成不适用

From the Model to the Adaptation of a Therapeutic Education Program in Cancer Research: the Case of Renal Cancer Patients Treated by Oral Treatments, Multidisciplinary Approach

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年3月9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
24
试验地点
1
主要终点
Health quality of life with QLQC30 questionnaire

研究概览

简要总结

The use of oral targeted therapies draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals [1,2]. These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this "learning" [3]. Nevertheless, in France, the therapeutic educational programs, built according to the "standards" of the therapeutic education (TE), are still very rare in cancer research [4]. In May 2012, a therapeutic educational program for these patients has been developed in the oncology department of the Teaching Hospital of Bordeaux through a multidisciplinary team. This program, dedicated to metastatic renal cancer patients treated by oral targeted therapies, becomes here an object of research: MODAP (action-research).

详细描述

At the diagnosis, 25 to 30 % of renal cancer patients present a metastatic disease. The prognosis remains dark in spite of the advent of the targeted therapies from 2007. Actually, the use of oral targeted therapies, most of the time carried out on an outpatient basis (sunitinib in particular), draws new medical management but also new practices for the patients (compliance), their family and the healthcare professionals [1,2].

These therapies have sometimes heavy toxicity: side effects to identify, to treat, and for the patient to learn to manage. This situation underlines the importance of a therapeutic education to accompany this "learning" [3]. Nevertheless, the therapeutic educational programs, built according to the "standards" of the therapeutic education (TE), are still very rare in cancer research [4]: multiplicity of the pathology (a cancer, cancers), multiplicity of the patients' experiences, the difficulty of implementation? In May 2012, in front of the experience told by the patients and the professionals in the context of metastatic renal cancer, the members of the oncology department of the Teaching Hospital of Bordeaux, the therapeutic educational Federation, the Coordination Cancer Centre (3C), an anthropologist, an expert patient and a patient's association developed a therapeutic educational program for these patients [current approval].

This program, built on the model of the TE in France, becomes here an object of research: MODAP (action-research).

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Age = 18 years old
  • Metastatic Renal cancer (carcinoma with clear cells and other subcategories)
  • Indication of a first line of treatment of therapy targeted by Sutent ©
  • General WHO 0-2 state
  • Life expectancy = 12 weeks
  • Agree to participate in MODAP (Therapeutic Education)

排除标准

  • History of other cancer
  • History of severe psychiatric affection

结局指标

主要结局

Health quality of life with QLQC30 questionnaire

时间窗: Three years

次要结局

  • Participation rate to the program stages(Two years)
  • Number of rendez-vous changed by the healers(Two years)
  • Number of calls by nurses(Two years)
  • Number of rendez-vous changed by the patient(Two years)
  • Number of therapeutic education procedures stages versus the number realized(Two years)

研究者

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

研究点 (1)

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