title: Development and evaluation of a cancer-related fatigue patient education program: protocol of a randomized controlled trial.
abstract: BACKGROUND
  Cancer-related fatigue (CRF) and its impact on patients' quality of life has been an increasing subject of research. However, in Germany there is 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 was reviewed and validated by an interdisciplinary expert group and the training-modules will be pretested with a small number of participants and discussed in terms of feasibility and acceptance.To determine the efficacy of the program a randomised controlled trial will be carried out: 300 patients will be recruited from oncological practices in Bremen, Germany, and will be allocated to intervention or control group. The intervention group participates in the program, whereas the control group receives standard care and the opportunity to take part in the program after the end of the follow-up (waiting control group). Primary outcome measure is the level of fatigue, secondary outcome measures are quality of life, depression, anxiety, self-efficacy and physical activity. Data will be collected before randomisation, after intervention, and after a follow-up of 6 months.
  
  
  CONCLUSIONS
  Because 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 and their contributions have been integrated into the curriculum. The experts appreciated the program as filling a gap in outpatient cancer care.If the results of the evaluation prove to be satisfactory, the outpatient care of cancer patients can be broadened and supplemented.
  
  
  BACKGROUND
  ClinicalTrials NCT00552552.
authors.affiliation: University of Bremen, Institute of Public Health and Nursing Research IPP, Department of Research on Interdisciplinary Ageing and Nursing, Grazer Str, 4, 28359 Bremen, Germany. nstuhldreher@uni-bremen.de
authors.forename: Nina
authors.initials: N
authors.lastname: Stuhldreher
authors.forename: Karl
authors.initials: K
authors.lastname: Reif
authors.forename: Ulrike
authors.initials: U
authors.lastname: de Vries
authors.forename: Stefan
authors.initials: S
authors.lastname: Görres
authors.forename: Franz
authors.initials: F
authors.lastname: Petermann