Cancer Fatigue Education Program

Not Applicable

Completed

• Conditions: Patient With Histologically Confirmed Malignancy
• Interventions: Behavioral: fatigue education program

• Registration Number: NCT01278147
• Lead Sponsor: Institut de Cancérologie de la Loire

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-01
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Last Update Submitted: 2011-01-14
• Study First Posted: 2011-01-17
• Last Update Posted: 2011-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education program	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.

Primary Outcome Measures

Name	Time	Method
Education program	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).

Secondary Outcome Measures

Name	Time	Method
self-evaluation	8 weeks	One secondary efficacy variables will comprise self-evaluation of patient quality of life measured using the SF-36 scale
healthcare structures	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).

Trial Locations

Locations (7)

PIVOT; 🇫🇷 Besancon, France

BACHELOT Thomas; 🇫🇷 Lyon, France

BLAY; 🇫🇷 Lyon, France

ZANETTA; 🇫🇷 Dijon, France

LAFONT; 🇫🇷 Lyon, France

CLAVREUL; 🇫🇷 Saint-etienne, France

CHOLLET; 🇫🇷 Clermont-ferrand, France