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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Besancon、フランス
- PIVOT
-
Clermont-ferrand、フランス
- CHOLLET
-
Dijon、フランス
- ZANETTA
-
Lyon、フランス、69000
- BACHELOT Thomas
-
Lyon、フランス、69000
- BLAY
-
Lyon、フランス、69000
- LAFONT
-
Saint-etienne、フランス、42100
- CLAVREUL
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：controle
patient without fatigue education program
|
|
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実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Education program
時間枠：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).
|
8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
self-evaluation
時間枠：8 weeks
|
One secondary efficacy variables will comprise self-evaluation of patient quality of life measured using the SF-36 scale
|
8 weeks
|
|
healthcare structures
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Franck CHAUVIN, Pr、Institut de Cancérologie de la Loire
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
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