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
  Purpose

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.


Condition Intervention
Cancer-Related Fatigue
Behavioral: Fatigue Patient Education Program (FIBS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Development and Evaluation of a Cancer-Related Fatigue Patient Education Program

Resource links provided by NLM:


Further study details as provided by University of Bremen:

Primary Outcome Measures:
  • Fatigue [ Time Frame: Baseline, after the intervention, 6 months later ]

Secondary Outcome Measures:
  • Quality of Life, Depression and anxiety, physical activity [ Time Frame: Baseline, after the intervention, 6 months later ]

Estimated Enrollment: 300
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Arms Assigned Interventions
Experimental: 1 Behavioral: Fatigue Patient Education Program (FIBS)
6 weekly sessions, 90 min each
Other Name: FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)
2
waiting control group
Behavioral: Fatigue Patient Education Program (FIBS)
Participation in the program after the second follow-up
Other Name: FIBS (Fatigue individuell bewältigen - ein Selbstmanagementprogramm)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552552

Contacts
Contact: Karl Reif +49 421- 218 ext 9055 karlreif@uni-bremen.de
Contact: Nina Egger +49 421- 218 ext 3500 negger@uni-bremen.de

Sponsors and Collaborators
University of Bremen
Institute of Public Health and Nursing Research (IPP)
German Federal Ministry of Education and Research
Bremer Krebsgesellschaft e.V.
Investigators
Principal Investigator: Karl Reif IPP
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00552552     History of Changes
Other Study ID Numbers: 41100133
Study First Received: October 31, 2007
Last Updated: November 1, 2007
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by University of Bremen:
cancer-related fatigue
self-management
patient education
cancer survivors
chronic disease

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014