Measuring Health Related Quality of Life in Lung Cancer Clinical Trials — An Overview of the Database ClinicalTrials.gov
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Background: In Germany, and throughout the world, the lung carcinoma is one of the most common and aggressive forms of cancer. Not only is the diagnosis itself stressful for the patients, but also the disease symptoms, such as (blood) cough, shortness of breath, pain in the chest and shoulders, in addition to the (toxic) side effects of therapies such as fatigue, weight loss, nausea, vomiting or diarrhea. While differences in clinical effectiveness decline, therapeutic alternatives must have a unique selling point. Accordingly, from the perspective of the industry, a stronger focus on patients’ quality of life is the consequence which is also requested by researchers and institutions.
The aim of this study is to investigate whether a change in clinical research is taking place with reference to the inclusion of health related quality of life as an outcome measure in lung cancer trials and, if applicable, what instruments are used for this purpose.
Methods: Using the ClinicalTrials.gov database, we conducted systematic research in late 2010. In particular we examined the quantity of lung cancer trials focusing on health related quality of life as well as on the instruments used. Comparisons were made over time (2005–2010).
Results: “Overall survival” still prevails as the primary endpoint, whereas in clinical trials with biotechnology interventions the measurement of “progression-free survival” was claimed more often as the primary study endpoint. In approximately 10% of the trials “Quality of Life” is indicated as an endpoint. Lung cancer-specific questionnaires like the EORTC LC13, LCSS and FACT-L are most frequently used, sometimes in combination with the generic EQ-5D. Symptom-specific measurements are rare.
Conclusions: A change in clinical research referring to the inclusion of health related quality of life as an outcome measure in lung cancer trials could not be found.
KeywordsDocetaxel Carboplatin Gefitinib Erlotinib Pemetrexed
Lebensqualitätsmessung in klinischen Studien beim Lungenkarzinom — Übersicht anhand der Datenbank ClinicalTrials.gov
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- 1.Robert Koch Institut, Gesellschaft der epidemiologischen Krebsregister in Deutschland e. V. Krebs in Deutschland 2005/2006. Häufigkeiten und Trends. 7. Ausgabe, Berlin, 2010: 48Google Scholar
- 2.Ullmann U. Lebensqualität nach Diagnose Lungenkrebs. Edition Wissenschaft: Reihe Psychologie 73. Jg., Marburg: Tectum-Verlag, 2001: 21–4Google Scholar
- 6.Food and Drug Administration (FDA). Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009. Erhältlich unter URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf [Abgerufen 01.12.11]
- 20.ClinicalTrials.gov. About ClinicalTrials.gov. Erhältlich unter URL: http://clinicaltrials.gov/ct2/info/about [Abgerufen 30.12.10]
- 23.Hollen PJ, Gralla RJ, Kris MG, et al. Measurement of quality of life in patients with lung cancer in multicenter trials of new therapies. Psychometric assessment of the Lung Cancer Symptom Scale. Cancer 1994; 73(8): 2087–98Google Scholar
- 25.Brettschneider C, Lühmann D, Raspe H. Der Stellenwert von Patient-Reported Outcomes (PRO) im Kontext von Health Technology Assessment (HTA). Informative value of Patient-Reported Outcomes (PRO) in Health Technology Assessment (HTA). Schriftenreihe Health Technology Assessment Bd. 109., 1. Aufl. Köln: DIMDI, 2011. Erhältlich unter URL: http://portal.dimdi.de/de/hta/hta_berichte/hta220_bericht_de.pdf [Abgerufen 01.12.11]