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Clinical Trial
. 2014 Jul;50(11):1957-63.
doi: 10.1016/j.ejca.2014.04.018. Epub 2014 May 9.

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

Marieke van Leeuwen  1 , Fabio Efficace  2 , Sophie D Fosså  3 , Michel Bolla  4 , Ugo De Giorgi  5 , Ronald de Wit  6 , Bernhard Holzner  7 , Lonneke V van de Poll-Franse  8 , Hendrik van Poppel  9 , Jeff White  10 , Laurence Collette  11 , Susanne Osanto  12 , Neil K Aaronson  13 ; European Organisation for Research and Treatment of Cancer Quality of Life Group; Genito-Urinary Cancers Group; Radiation Oncology Group
Affiliations
Clinical Trial

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

Marieke van Leeuwen et al. Eur J Cancer. 2014 Jul.

Abstract

Objectives: 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.

Keywords: Cancer survivorship; Health outcomes research; Long-term follow-up; Prostate cancer; Quality of life; Survey research; Testicular cancer.

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