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Eur J Cancer. 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.

Author information

1
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, The Netherlands.
2
Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center, Rome, Italy.
3
Department of Clinical Cancer Research, Rikshospitalet-Radiumhospitalet Medical Center, Oslo, Norway.
4
Department of Radiation Oncology, Centre Hospitalier Universitaire A Michallon, Grenoble, France.
5
Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) - IRCCS, Meldola, Italy.
6
Department of Medical Oncology, Erasmus MC University Hospital and the ErasmusMC Cancer Institute, Rotterdam, The Netherlands.
7
Department of Psychiatry, Innsbruck University Hospital, Innsbruck, Austria.
8
Center of Research on Psychology in Somatic Diseases (CoRPS), Tilburg University, Tilburg, The Netherlands.
9
Department of Urology, University Hospital, KU Leuven, Leuven, Belgium.
10
The Beatson West of Scotland Cancer Center, Glasgow, Scotland, United Kingdom(1).
11
Statistics Department, EORTC Headquarters, Brussels, Belgium.
12
Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
13
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, The Netherlands. Electronic address: n.aaronson@nki.nl.

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

PMID:
24820932
DOI:
10.1016/j.ejca.2014.04.018
[Indexed for MEDLINE]

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