Development and Evaluation of a Cancer-Related Fatigue Patient Education Program (FIBS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by University of Bremen.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Institute of Public Health and Nursing Research (IPP)
German Federal Ministry of Education and Research
Bremer Krebsgesellschaft e.V.
Information provided by:
University of Bremen
ClinicalTrials.gov Identifier:
NCT00552552
First received: October 31, 2007
Last updated: November 1, 2007
Last verified: October 2007

October 31, 2007
November 1, 2007
January 2008
Not Provided
Fatigue [ Time Frame: Baseline, after the intervention, 6 months later ]
Same as current
Complete list of historical versions of study NCT00552552 on ClinicalTrials.gov Archive Site
Quality of Life, Depression and anxiety, physical activity [ Time Frame: Baseline, after the intervention, 6 months later ]
Same as current
Not Provided
Not Provided
 
Development and Evaluation of a Cancer-Related Fatigue Patient Education Program
Development and Evaluation of a Cancer-Related Fatigue Patient Education Program

The objective of this study is to develop a structured and evidence-based self-management program to cope with cancer-related fatigue and to assess the efficacy of the intervention in cancer survivors.

Background

Cancer-related fatigue (CRF) and its impact on patients quality of life has been an increasing subject of research. However, in Germany exists a lack of evidence-based interventions consistent with the multidimensional character of fatigue. The objective of this study is to develop and evaluate a self-management program for disease-free cancer patients to cope with CRF.

Methods

Based on evidence extracted from a literature review a curriculum for the self-management program was elaborated. The curriculum is currently being reviewed and validated by an expert group of oncologists, psycho-oncologists, nurses, social workers, physical therapists, health scientists, and patients. The modules will be pretested with a small number of patients, discussed in terms of feasibility and acceptance.

To determine the efficacy of the program a randomised controlled trial will be conducted: 300 patients will be allocated to an intervention or a waiting control group. Data will be collected before randomisation, after intervention, and after a follow-up of 6 months.

Results

As essential subjects for the curriculum were identified:

  • medical background and causes of CRF
  • physical activity and moderate exercise
  • restructuring daily schedules
  • energy conservation
  • stress-management and relaxation strategies
  • coping with negative emotions
  • integrating the new knowledge into every day life.

The program aims at impacting on health-related self-efficacy by the training of problem solving, goal setting, and cognitive techniques as knowledge transfer hasn't proved sufficient to achieve changes in behaviour. According to this we developed a curriculum wherein detailed information for every module concerning objectives, background, didactic methods and materials are provided. Based on the curriculum train-the-trainer seminars are held in order to educate on moderation techniques, group dynamics, and clinical background of CRF. The program will be administered by qualified health professionals in groups of eight patients. It includes six weekly sessions 90 minutes each dealing with the topics listed above.

The results of the pre-test are currently being analysed.

Discussion

Due to the fact that there are no comparable self-management programs for cancer survivors with fatigue the development of the curriculum has been complex. Therefore the critical appraisal by the experts was an important step to validate the program: their contributions have been integrated into the curriculum. The experts appreciated the program as filling in a gap of outpatient cancer care.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Cancer-Related Fatigue
  • Behavioral: Fatigue Patient Education Program (FIBS)
    6 weekly sessions, 90 min each
    Other Name: FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)
  • Behavioral: Fatigue Patient Education Program (FIBS)
    Participation in the program after the second follow-up
    Other Name: FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)
  • Experimental: 1
    Intervention: Behavioral: Fatigue Patient Education Program (FIBS)
  • 2
    waiting control group
    Intervention: Behavioral: Fatigue Patient Education Program (FIBS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
December 2009
Not Provided

Inclusion Criteria:

  • adult
  • malign neoplasms
  • ECOG performance status of 0-2
  • moderate or severe fatigue
  • stable condition after treatment
  • German speaking

Exclusion Criteria:

  • life expectancy < 1 year
  • patients with brain neoplasms
  • suicidal tendencies
  • severe psychiatric disorders
Both
18 Years and older
No
Contact: Karl Reif +49 421- 218 ext 9055 karlreif@uni-bremen.de
Contact: Nina Egger +49 421- 218 ext 3500 negger@uni-bremen.de
Not Provided
 
NCT00552552
41100133
Not Provided
Not Provided
University of Bremen
  • Institute of Public Health and Nursing Research (IPP)
  • German Federal Ministry of Education and Research
  • Bremer Krebsgesellschaft e.V.
Principal Investigator: Karl Reif IPP
University of Bremen
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP