Study Results
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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COMPLETED
NA
200 participants
INTERVENTIONAL
2007-05-31
2010-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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controle
patient without fatigue education program
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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) 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
18 Years
80 Years
ALL
No
Sponsors
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Institut de Cancérologie de la Loire
OTHER
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
CHOLLET
Clermont-Ferrand, , France
ZANETTA
Dijon, , France
BACHELOT Thomas
Lyon, , France
BLAY
Lyon, , France
LAFONT
Lyon, , France
CLAVREUL
Saint-Etienne, , France
Countries
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Other Identifiers
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2007-A00147-46
Identifier Type: -
Identifier Source: org_study_id
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