Cancer Fatigue Education Program

January 14, 2011 updated by: Institut de Cancérologie de la Loire

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France
        • PIVOT
      • Clermont-ferrand, France
        • CHOLLET
      • Dijon, France
        • ZANETTA
      • Lyon, France, 69000
        • BACHELOT Thomas
      • Lyon, France, 69000
        • BLAY
      • Lyon, France, 69000
        • LAFONT
      • Saint-etienne, France, 42100
        • CLAVREUL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Education program
Time Frame: 8 weeks
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).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-evaluation
Time Frame: 8 weeks
One secondary efficacy variables will comprise self-evaluation of patient quality of life measured using the SF-36 scale
8 weeks
healthcare structures
Time Frame: 8 weeks
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).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de la Loire

Investigators

  • Principal Investigator: Franck CHAUVIN, Pr, Institut de Cancerologie de la Loire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

January 17, 2011

Last Update Submitted That Met QC Criteria

January 14, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-A00147-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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