title: Health related quality of life outcomes in cancer clinical trials.
abstract: Over the last decade, health related quality of life (HRQOL) investigations have become an increasingly important part of many cancer clinical trial research programs. This paper presents a review of all HRQOL studies published by the European Organisation for Research and Treatment of Cancer (EORTC), one of the largest clinical trials organisations in Europe. The findings highlight 24 clinical trials that have been published to date, enrolling over 9000 patients. HRQOL is fully integrated into EORTC phase III trials. In many trials, HRQOL provides a valuable source of additional information useful to both clinician and patient when making treatment decisions. Furthermore, several trials have found that the combined use of clinical information along with HRQOL data has led to the development of new standards of care in several different cancer sites. With more than 40 ongoing HRQOL studies in the EORTC, we expect HRQOL to play an even greater role over the coming decade in helping establish the optimal treatment and care approach for cancer patients.
authors.affiliation: EORTC Data Center, Quality of Life Unit, Avenue E. Mounier, 83, 1200 Brussels, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Bottomley
authors.forename: H
authors.initials: H
authors.lastname: Flechtner
authors.forename: F
authors.initials: F
authors.lastname: Efficace
authors.forename: V
authors.initials: V
authors.lastname: Vanvoorden
authors.forename: C
authors.initials: C
authors.lastname: Coens
authors.forename: P
authors.initials: P
authors.lastname: Therasse
authors.forename: G
authors.initials: G
authors.lastname: Velikova
authors.forename: J
authors.initials: J
authors.lastname: Blazeby
authors.forename: E
authors.initials: E
authors.lastname: Greimel
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D006304:Health Status; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D011788:Quality of Life