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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Besancon, 프랑스
- PIVOT
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Clermont-ferrand, 프랑스
- CHOLLET
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Dijon, 프랑스
- ZANETTA
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Lyon, 프랑스, 69000
- BACHELOT Thomas
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Lyon, 프랑스, 69000
- BLAY
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Lyon, 프랑스, 69000
- LAFONT
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Saint-etienne, 프랑스, 42100
- CLAVREUL
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: controle
patient without fatigue education program
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실험적: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Education program
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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self-evaluation
기간: 8 weeks
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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
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healthcare structures
기간: 8 weeks
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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).
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8 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Franck CHAUVIN, Pr, Institut de Cancérologie de la Loire
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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