Cancer Fatigue Education Program

NCT ID: NCT01278147

Last Updated: 2011-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Patient With Histologically Confirmed Malignancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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controle

patient without fatigue education program

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

fatigue education program

Intervention Type BEHAVIORAL

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.

Interventions

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fatigue 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Cancérologie de la Loire

OTHER

Sponsor Role lead

Responsible Party

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Institut de Cancérologie de la Loire

Principal Investigators

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Franck CHAUVIN, Pr

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de la Loire

Locations

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PIVOT

Besançon, , France

Site Status

CHOLLET

Clermont-Ferrand, , France

Site Status

ZANETTA

Dijon, , France

Site Status

BACHELOT Thomas

Lyon, , France

Site Status

BLAY

Lyon, , France

Site Status

LAFONT

Lyon, , France

Site Status

CLAVREUL

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2007-A00147-46

Identifier Type: -

Identifier Source: org_study_id

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