title: Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies: challenges and opportunities.
abstract: OBJECTIVE
  In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting such research.
  
  
  METHODS
  In this cross-sectional study, we recruited long-term, disease-free survivors from two mature EORTC clinical trials in testicular and prostate cancer from centres in Northern and Southern Europe, and the United Kingdom (UK).
  
  
  RESULTS
  A number of challenges were encountered in recruiting participating centres, obtaining medical ethical approval and in recruiting survivors and collecting the health-related quality of life (HRQoL) data in a timely manner. The efficiency with which the study could be conducted varied widely across centres and countries. Time to obtain medical ethical approval for the study ranged from 1.5 to 25 months. We encountered most problems with ethical approval in the UK, Italy and Belgium. In most cases, data collection was completed within 3 months (range 10 weeks-1 year). Completed questionnaires were obtained from 68% and 56%, respectively, of the testicular and prostate cancer survivors who were approached.
  
  
  CONCLUSIONS
  HRQoL research among long-term survivors of EORTC phase III clinical trials is possible, but the process of ethical approval and data collection is a lengthy one. To minimise many of the logistical problems, long-term follow-up of patients should be an integral part of future clinical trials. Moreover, regulations governing medical ethical approval for clinical research within the EU should be carefully evaluated to facilitate long-term follow-up of cancer survivors in Europe.
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, The Netherlands.
authors.forename: Marieke
authors.initials: M
authors.lastname: van Leeuwen
authors.affiliation: Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center, Rome, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
authors.affiliation: Department of Clinical Cancer Research, Rikshospitalet-Radiumhospitalet Medical Center, Oslo, Norway.
authors.forename: Sophie D
authors.initials: SD
authors.lastname: Fosså
authors.affiliation: Department of Radiation Oncology, Centre Hospitalier Universitaire A Michallon, Grenoble, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Bolla
authors.affiliation: Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) - IRCCS, Meldola, Italy.
authors.forename: Ugo
authors.initials: U
authors.lastname: De Giorgi
authors.affiliation: Department of Medical Oncology, Erasmus MC University Hospital and the ErasmusMC Cancer Institute, Rotterdam, The Netherlands.
authors.forename: Ronald
authors.initials: R
authors.lastname: de Wit
authors.affiliation: Department of Psychiatry, Innsbruck University Hospital, Innsbruck, Austria.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Holzner
authors.affiliation: Center of Research on Psychology in Somatic Diseases (CoRPS), Tilburg University, Tilburg, The Netherlands.
authors.forename: Lonneke V
authors.initials: LV
authors.lastname: van de Poll-Franse
authors.affiliation: Department of Urology, University Hospital, KU Leuven, Leuven, Belgium.
authors.forename: Hendrik
authors.initials: H
authors.lastname: van Poppel
authors.affiliation: The Beatson West of Scotland Cancer Center, Glasgow, Scotland, United Kingdom(1).
authors.forename: Jeff
authors.initials: J
authors.lastname: White
authors.affiliation: Statistics Department, EORTC Headquarters, Brussels, Belgium.
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
authors.affiliation: Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Susanne
authors.initials: S
authors.lastname: Osanto
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, The Netherlands. Electronic address: n.aaronson@nki.nl.
authors.forename: Neil K
authors.initials: NK
authors.lastname: Aaronson
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D003430:Cross-Sectional Studies; D018572:Disease-Free Survival; D005060:Europe; D006801:Humans; D008297:Male; D018579:Patient Selection; D010865:Pilot Projects; D011471:Prostatic Neoplasms / Q000523:psychology* / Q000628:therapy*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D017741:Survivors; D013736:Testicular Neoplasms / Q000523:psychology* / Q000628:therapy*
keywords: Cancer survivorship; Health outcomes research; Long-term follow-up; Prostate cancer; Quality of life; Survey research; Testicular cancer