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Completed

NCT Number: NCT01278147

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.

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Key information

Conditions

Patient With Histologically Confirmed Malignancy Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PIVOT, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fatigue education program

Behavioral

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 outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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).

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de la Loire

Other

Registry information

Official study title

Development and Implementation of a Cancer Fatigue Education Program

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 17, 2011
Registry last updated
Jan 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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