Development and Implementation of a Cancer Fatigue Education Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Education program
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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.
排除标准
- •- 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
结局指标
主要结局
Education program
时间窗: 8 weeks
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).
次要结局
- self-evaluation(8 weeks)
- healthcare structures(8 weeks)