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

Cancer-Related Fatigue Clinical Trial

— FIBS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00552552
• Other study ID #: 41100133
• Status: Not yet recruiting
• Phase: N/A
• First received: October 31, 2007
• Last updated: November 1, 2007
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2007
• Source: University of Bremen
• Contact: Karl Reif
• Phone: +49 421- 218
• Email: karlreif[@]uni-bremen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer-Related Fatigue
• Fatigue

Intervention

Behavioral:
• Fatigue Patient Education Program (FIBS)
6 weekly sessions, 90 min each
• Fatigue Patient Education Program (FIBS)
Participation in the program after the second follow-up

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Bremen	Bremer Krebsgesellschaft e.V., German Federal Ministry of Education and Research, Institute of Public Health and Nursing Research (IPP)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue		Baseline, after the intervention, 6 months later
Secondary	Quality of Life, Depression and anxiety, physical activity		Baseline, after the intervention, 6 months later