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Cancer Fatigue Education Program

This study has been completed.
Sponsor:
Information provided by:
Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier:
NCT01278147
First received: January 14, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Patient With Histologically Confirmed Malignancy
 Behavioral: fatigue education program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Development and Implementation of a Cancer Fatigue Education Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut de Cancérologie de la Loire:

Primary Outcome Measures:
  • Education program [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • self-evaluation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    One secondary efficacy variables will comprise self-evaluation of patient quality of life measured using the SF-36 scale

  • healthcare structures [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 200
Study Start Date: May 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: controle
patient without fatigue education program
Experimental: 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.
 Behavioral: 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278147

Locations
France
PIVOT
Besancon, France
CHOLLET
Clermont-ferrand, France
ZANETTA
Dijon, France
LAFONT
Lyon, France, 69000
BACHELOT Thomas
Lyon, France, 69000
BLAY
Lyon, France, 69000
CLAVREUL
Saint-etienne, France, 42100
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
Principal Investigator: Franck CHAUVIN, Pr Institut de Cancérologie de la Loire
  More Information

No publications provided

Responsible Party: Professeur Franck Chauvin, Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT01278147     History of Changes
Other Study ID Numbers: 2007-A00147-46
Study First Received: January 14, 2011
Last Updated: January 14, 2011
Health Authority: French: Direction Générale de la Santé

Keywords provided by Institut de Cancérologie de la Loire:
cancer
fatigue program education

Additional relevant MeSH terms:
Neoplasms
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013