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

January 14, 2011
January 14, 2011
May 2007
June 2010   (final data collection date for primary outcome measure)
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).
Same as current
No Changes Posted
  • 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).
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Patient With Histologically Confirmed Malignancy
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.
  • 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.
    Intervention: Behavioral: fatigue education program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01278147
2007-A00147-46
No
Professeur Franck Chauvin, Institut de Cancérologie de la Loire
Institut de Cancérologie de la Loire
Not Provided
Principal Investigator: Franck CHAUVIN, Pr Institut de Cancérologie de la Loire
Institut de Cancérologie de la Loire
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP