Cancer Fatigue Education Program
Development and Implementation of a Cancer Fatigue Education Program
The purpose of the present project is to develop, implement and evaluate a pilot regional patient education program on the management of one of the main side effects of chemotherapy in cancer patients, that is fatigue.
A carer (doctor or nurse) trained in educational techniques will be responsible for the patient. The carer will first identify modes of behavior and competences that the patient must acquire in order to optimize his/her management of fatigue ("educational diagnosis"). An education program, based on a contract of goals will be proposed after this diagnosis phase. The expected results are, in the short-term, a significant reduction in the mean level of fatigue in patients receiving chemotherapy who benefited from individual educational management. In the longer term, the aim is to evaluate the impact of this program on patient quality of life and use of healthcare structures in comparison with conventional management.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Besancon、法国
- PIVOT
-
Clermont-ferrand、法国
- CHOLLET
-
Dijon、法国
- ZANETTA
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Lyon、法国、69000
- BACHELOT Thomas
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Lyon、法国、69000
- BLAY
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Lyon、法国、69000
- LAFONT
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Saint-etienne、法国、42100
- CLAVREUL
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- - Age> 18 years.
- Patient with histologically confirmed malignancy, during initial treatment with chemotherapy, followed or not by surgery, or the first week of radiotherapy. Patients with hematologic malignancy (including non-Hodgkin's lymphoma or Hodgkin's disease) may be included in the study, except for patients with leukemia.
- Having a fatigue up during the week preceding the inclusion level measured by the average patient with 2 or more on a visual analogue scale (VAS) graded from 0 to 10 (0 expressing no fatigue and 10 the maximum fatigue imaginable ).
- Volunteered to participate in PEPs "Coping with fatigue."
- Usually followed as outpatients.
- Condition preserved (ECOG PS 2).
- Available for all meetings of the educational program (5 sessions of 2 hours over a period of 5 weeks).
- Able to read, write and understand French.
- Resident (s) in a 50 km radius around the center investigator.
- Can be contacted by phone.
- Compulsory membership of a social security system.
- Obtaining informed consent in writing, signed and dated.
Exclusion Criteria:
- - Patient (e) with the inclusion anemia with a hemoglobin level below 10 g/100 mL.
- Patient (e) having a documented history of cognitive or psychiatric disorders.
- Patient (e) can not be followed for family, social, geographical or psychological.
- Patient (e) deprived of their liberty by court or administrative
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：controle
patient without fatigue education program
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|
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实验性的：Education program
the carer will help the patient develop competences on the following points: how to evaluate the severity of the fatigue; learn to recognize symptoms or prodromes showing associated difficulties (anxiety, fear, depression); how to improve control of fatigue by setting up suitable strategies (management of periods of activity and rest, physical and/or intellectual exercises, dietary program, complementary therapy); learn to ask for and accept the help of close relations or carers.
|
the carer will help the patient develop competences on the following points: how to evaluate the severity of the fatigue; learn to recognize symptoms or prodromes showing associated difficulties (anxiety, fear, depression); how to improve control of fatigue by setting up suitable strategies (management of periods of activity and rest, physical and/or intellectual exercises, dietary program, complementary therapy); learn to ask for and accept the help of close relations or carers.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Education program
大体时间：8 weeks
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The main indicator of patient satisfaction after the education program will be the change during 8 weeks of follow-up in the mean fatigue score measured on a specific scale (FACT-F) (32).
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8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
self-evaluation
大体时间：8 weeks
|
One secondary efficacy variables will comprise self-evaluation of patient quality of life measured using the SF-36 scale
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8 weeks
|
|
healthcare structures
大体时间：8 weeks
|
The secondary efficacy variables will comprise evaluation of the use by patients of healthcare structures (phone calls, number of home visits, number of days of hospitalization, visits to emergency departments, other carers).
|
8 weeks
|
合作者和调查者
调查人员
- 首席研究员：Franck CHAUVIN, Pr、Institut de Cancérologie de la Loire
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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