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Cancer Fatigue Education Program

Primary Purpose

Patient With Histologically Confirmed Malignancy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fatigue education program
Sponsored by
Institut de Cancérologie de la Loire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patient With Histologically Confirmed Malignancy focused on measuring cancer, fatigue program education

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PIVOT
  • CHOLLET
  • ZANETTA
  • BACHELOT Thomas
  • BLAY
  • LAFONT
  • CLAVREUL

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

controle

Education program

Arm Description

patient without 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.

Outcomes

Primary Outcome Measures

Education program
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
One secondary efficacy variables will comprise self-evaluation of patient quality of life measured using the SF-36 scale
healthcare structures
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).

Full Information

First Posted
January 14, 2011
Last Updated
January 14, 2011
Sponsor
Institut de Cancérologie de la Loire
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1. Study Identification

Unique Protocol Identification Number
NCT01278147
Brief Title
Cancer Fatigue Education Program
Official Title
Development and Implementation of a Cancer Fatigue Education Program
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut de Cancérologie de la Loire

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient With Histologically Confirmed Malignancy
Keywords
cancer, fatigue program education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
controle
Arm Type
No Intervention
Arm Description
patient without fatigue education program
Arm Title
Education program
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
fatigue education program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Education program
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
self-evaluation
Description
One secondary efficacy variables will comprise self-evaluation of patient quality of life measured using the SF-36 scale
Time Frame
8 weeks
Title
healthcare structures
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck CHAUVIN, Pr
Organizational Affiliation
Institut de Cancérologie de la Loire
Official's Role
Principal Investigator
Facility Information:
Facility Name
PIVOT
City
Besancon
Country
France
Facility Name
CHOLLET
City
Clermont-ferrand
Country
France
Facility Name
ZANETTA
City
Dijon
Country
France
Facility Name
BACHELOT Thomas
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
BLAY
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
LAFONT
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
CLAVREUL
City
Saint-etienne
ZIP/Postal Code
42100
Country
France

12. IPD Sharing Statement

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Cancer Fatigue Education Program

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