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

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Trial Information

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


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.


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.


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.


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.

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

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

Baseline, after the intervention, 6 months later

Principal Investigator

Karl Reif

Investigator Role:

Principal Investigator

Investigator Affiliation:



Germany: Federal Ministry of Education and Research

Study ID:




Start Date:

January 2008

Completion Date:

December 2009

Related Keywords:

  • Cancer-Related Fatigue
  • cancer-related fatigue
  • self-management
  • patient education
  • cancer survivors
  • chronic disease
  • Fatigue