Clinical trial NCT01278147: Cancer Fatigue Education Program
Official title: Development and Implementation of a Cancer Fatigue Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient With Histologically Confirmed Malignancy
Keywords: cancer
fatigue program education
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Education program
timeFrame: 8 weeks
Secondary outcomes:
measure: self-evaluation
timeFrame: 8 weeks
measure: healthcare structures
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Besancon
country: France
facility: PIVOT
city: Clermont-ferrand
country: France
facility: CHOLLET
city: Dijon
country: France
facility: ZANETTA
city: Lyon
country: France
facility: BACHELOT Thomas
city: Lyon
country: France
facility: BLAY
city: Lyon
country: France
facility: LAFONT
city: Saint-etienne
country: France
facility: CLAVREUL
Study officials:
affiliation: Institut de Cancérologie de la Loire
name: Franck CHAUVIN, Pr
role: PRINCIPAL_INVESTIGATOR
References: