title: Development of an EORTC quality of life phase III module measuring cancer-related fatigue (EORTC QLQ-FA13).
abstract: BACKGROUND
  European Organisation for Research and Treatment of Cancer (EORTC) has developed a new multidimensional instrument measuring cancer-related fatigue that can be used in conjunction with the quality of life core questionnaire, EORTC QLQ-C30. The paper focuses on the development of the phase III module, collaborating with seven European countries, including a patient sample of 318 patients.
  
  
  METHODS
  The methodology followed the EORTC guidelines for developing phase III modules. Patients were assessed by questionnaires (EORTC QLQ-C30 with the EORTC Fatigue Module FA15) followed by an interview, asking for their opinions on the difficulty in understanding, on annoyance and on intrusiveness.
  
  
  RESULTS
  The phase II FA15 was revised on the basis of qualitative analyses (comments of the patients), quantitative results (descriptive statistics) as well as the multi-item response theory analyses. The three dimensions (physical, emotional and cognitive) of the scale could be confirmed.
  
  
  CONCLUSIONS
  As a result, EORTC QLQ-FA13 is now available as a valid phase III module measuring cancer-related fatigue in clinical trials and will be psychometrically improved in the upcoming phase IV.
authors.affiliation: Department Psychooncology, Tumor Biology Centre, University of Freiburg, Freiburg, Germany. weis@tumorbio.uni-freiburg.de
authors.forename: Joachim
authors.initials: J
authors.lastname: Weis
authors.forename: Juan Ignacio
authors.initials: JI
authors.lastname: Arraras
authors.forename: Thierry
authors.initials: T
authors.lastname: Conroy
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
authors.forename: Claudia
authors.initials: C
authors.lastname: Fleissner
authors.forename: Attila
authors.initials: A
authors.lastname: Görög
authors.forename: Eva
authors.initials: E
authors.lastname: Hammerlid
authors.forename: Bernhard
authors.initials: B
authors.lastname: Holzner
authors.forename: Louise
authors.initials: L
authors.lastname: Jones
authors.forename: Anne
authors.initials: A
authors.lastname: Lanceley
authors.forename: Susanne
authors.initials: S
authors.lastname: Singer
authors.forename: Markus
authors.initials: M
authors.lastname: Wirtz
authors.forename: Henning
authors.initials: H
authors.lastname: Flechtner
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005060:Europe; D005221:Fatigue / Q000175:diagnosis* / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000523:psychology*; D011788:Quality of Life / Q000523:psychology*; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D055815:Young Adult