Quality of life assessment and research in the EORTC (European Organisation for Research and Treatment of Cancer) H. Flechtner 1 , A. Bottomley 2 On behalf of the EORTC Quality of Life Group and Quality of Life Unit 1 Department of Child and Adolescent Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany 2 Quality of Life Unit, European Organisation for Research and Treatment of Cancer, Brussels, Belgium Correspondance: H. Flechtner, Klinik fu ¨ r Psychiatrie und Psychotherapie des Kindes- und Jugendalters, Universita ¨ t zu Ko ¨ ln, Robert-Koch-Str.10, 50931 Ko ¨ ln, Germany, e-mail: hans-henning.flechtner@uk-koeln.de Abstract: Quality of Life (QOL) assessment and research within the European Organisation for Research and Treatment of Cancer (EORTC) has become increasingly important over the past 25 years, starting already in 1979 with the founding of the EORTC Quality of Life Group (EORTC QLG), and QOL has become part of many cancer clinical trial protocols in different ways. This paper briefly presents an overview of QOL within the EORTC, the deve- lopment of the QLQ-C30 instrument, the construction of specific modules, issues of cross-cultural validation and translation, and the various other activities of the QLG and the Data Centre Quality of Life Unit (QLU). The article also includes key findings from selected QOL studies published by the EORTC, highlight- ing this large international clinical trial organisation’s contribution to this field of oncology. Keywords: Cancer – Quality of life – Clinical trials – EORTC – QLQ-C30 The EORTC quality of life group The formation of the Quality of Life Group (QLG) dates back to 1979, when a group of dedicated physi- cians and researchers met during a NCI-EORTC cancer drug symposium in Brussels to discuss the topic of « Quality of Life » in cancer medi- cine. An European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Study Group was founded and held its first mee- tings in Marseille and Amsterdam. The proceedings of these early workshops already included a num- ber of topics that set the scene for developments that would come in forthcoming years, such as theoreti- cal considerations of quality of life, measurement of quality of life in cancer patients, and management of psychological stress in cancer patients. Subsequent meetings consolidated the group’s assess- ment strategies and the develop- ment of the new instrument, later known as EORTC QLQ-C30, in var- ious European and non-European languages. In 1988, a report on the first EORTC quality of life field study #15861, studying the properties of the newly developed instrument in lung cancer patients, already inclu- ded 373 patients from 21 institutions in 15 countries. In 1987, the EORTC Monograph on Quality of Life was published [1], and in the following years formal subcommittees for module development and liaison work were created. The first EORTC Guidelines for module development were published, followed by transla- tion guidelines [4, 10]. Project groups for QOL in various areas started working and finally in 1993 the results of the big international field studies with the EORTC QLQ-C30 were published, making the instru- ment and its psychometric proper- ties available to the scientific community [2]. In 1994, the Quality of Life Unit (QLU) at the EORTC Data Centre in Brussels began work and the first manual in the series of « blue books », the QLQ-C30 scoring manual, was published, followed by an atlas of norms in 1996 [16]. The construction of the item bank follo- wed, along with the professional treatment of the growing number of QLQ-C30 translations and the multi- plying number of modules [8]. The series of « blue books » now comprise: Scoring Manual QLQ- C30, Reference Values Manual, Translation Guidelines, Module Development Guidelines, Guideli- nes for Assessing QOL in EORTC Clinical Trials, Item Bank Guidelines. QOL core instrumenT QLQ-C30 By 1993 the EORTC QLG had completed the development and validation of the QLQ-C30 core instrument. It was designed to be cancer-specific, multidimensional, self-administered, for use in cross- cultural settings and in conjunction with additional tumour- or treat- ment-specific modules. The 30 items on a four- or seven-category answer format cover five functional scales (physical, role, cognitive, emotional, and social), three symp- tom scales (fatigue, pain, and nau- sea and vomiting), and a global QOL scale. A number of single items address dyspnoea, loss of appetite, insomnia, constipation, diarrhoea, and financial impact of the disease. Instrument develop- ment continues and currently a Qualite ´ de vie Oncologie (2006) 8: 443–446 © Springer 2006 DOI 10.1007/s10269-006-0412-4 ORIGINAL 443