title: Quality of life research in endometrial cancer: what is needed to advance progress in this disease site? Methodological considerations from the Gynecologic Cancer InterGroup Symptom Benefit Working Group brainstorming session, Leiden 2012.
abstract: BACKGROUND
  Quality of life (QoL) in endometrial cancer (EC) is understudied. Incorporation of QoL questionnaires and patient-reported outcomes in clinical trials has been inconsistent, and the tools and interpretation of these measures are unfamiliar to most practitioners. In 2012, the Gynecologic Cancer InterGroup Symptom Benefit Working Group convened for a brainstorming collaborative session to address deficiencies and work toward improving the quality and quantity of QoL research in women with EC.
  
  
  METHODS
  Through literature review and international expert contributions, we compiled a comprehensive appraisal of current generic and disease site-specific QoL assessment tools, strengths and weaknesses of these measures, assessment of sexual health, statistical considerations, and an exploration of the unique array of histopathologic and clinical factors that may influence QoL outcomes in women with EC.
  
  
  RESULTS
  This collaborative composition is the first publication specific to EC that addresses methodology in QoL research and the components necessary to achieve high quality QoL data in clinical trials. Future recommendations regarding (1) the incorporation of patient-reported outcomes in all clinical trials in EC, (2) definition of an a priori hypothesis, (3) utilization of validated tools and consideration of new tools corresponding to new therapies or specific symptoms, (4) publication within the same time frame as clinical outcome data, and (5) attempt to correct for disease site-specific potential confounders are presented.
  
  
  CONCLUSIONS
  Improved understanding of methodology in QoL research and an increased undertaking of EC-specific QoL research in clinical trials are imperative if we are to improve outcomes in women with EC.
authors.affiliation: *Department of Gynecology and Obstetrics, University of British Columbia, Vancouver, British Columbia, Canada; †Department of Medical Psychology and Psychotherapy, Medical University of Graz, Graz, Austria; ‡Department of Clinical Oncology, Leiden UniversityMedical Center, Leiden, the Netherlands; §EORTC, Brussels, Belgium; ∥Department of Gynecologic Oncology, Karolinska University Hospital, Stockholm, Sweden; ¶Department of Medical Oncology, The Prince of Wales Hospital, University of New South Wales Clinical School, Sydney, Australia; and #Departments of Medical Oncology and Clinical Research, Centre Francois Baclesse, CHU Côte de Nacre, University of Basse Normandie, Caen, France.
authors.forename: Jessica N
authors.initials: JN
authors.lastname: McAlpine
authors.forename: Elfriede
authors.initials: E
authors.lastname: Greimel
authors.forename: Lori A
authors.initials: LA
authors.lastname: Brotto
authors.forename: Remy A
authors.initials: RA
authors.lastname: Nout
authors.forename: Emad
authors.initials: E
authors.lastname: Shash
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Avall-Lundqvist
authors.forename: Michael L
authors.initials: ML
authors.lastname: Friedlander
authors.forename: Florence
authors.initials: F
authors.lastname: Joly
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic / Q000379:methods*; D016889:Endometrial Neoplasms / Q000523:psychology* / Q000628:therapy; D005260:Female; D006301:Health Services Needs and Demand; D006801:Humans; D011379:Prognosis; D011788:Quality of Life / Q000523:psychology*