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Annals of Oncology 3:825-831, 1992
© 1992 European Society for Medical Oncology

research-article

Feasibility of quality of life assessment in a randomized phase III trial of small cell lung cancer

-a lesson from the real world-

C. Hürny1,, J. Bernhard1, R. Joss2, Y. Willems3, F. Cavalli3, J. Kiser4, K. Brunner4, S. Favre5, P. Alberto5, A. Glaus6, H. Senn6, E. Schatzmann1, P. A. Ganz7 and U. Metzger

The Swiss Group for Clinical Cancer Research SAKK Bern, Switzerland
1Quality of Life Office, Swiss Group for Clinical and Epidemiological Cancer Research SAKK Bern
2Division of Oncology, Department of Medicine, Kantonsspital Luzern
3Division of Oncology, Ospedale San Giovanni Bellinzona
4Institute of Medical Oncology, University of Bern Bern
5Division of Oncology-Hematology, Hôpital Cantonal universitaire Genéve;
6Department of Medicine C, Kantonsspital St. Gallen, Switzerland
7Division of Cancer Control, UCLA - Jonsson Comprehensive Cancer Center Los Angeles, USA
8Division of Surgery Stadtspital Triemli, Zürich, Switzerland

Christoph Hürny, M.D. Medical Division Lory Inselspital CH-3010 Bern Switzerland

Between 1985 and 1990 the Swiss Group for Clinical Cancer Research (SAKK) for the first time assessed quality of life (QL) variables in 188 patients in a multicenter small-cell lung cancer trial that compared two different regimens of combination chemotherapy. QL-assessment was scheduled at the beginning of each of the six treatment cycles. The self-rating QL questionnaire included an early version of the EORTC QL questionnaire, a mood adjective checklist (Bf-S) and a single linear analogue scale (LASA) measuring general well-being. Compliance with completion of the scheduled questionnaires varied between 37% and 58% over the six cycles, and between 21% and 68% among the 7 participating institutions. Mean compliance was 49%. The institution was found the only significant factor predicting compliance (p < 0.001). Patient age, sex, education and biological prognostic factors at randomization were not predictors of compliance. Although compliance was poor, the data received was of high quality. We suggest practical guidelines for improving compliance with QL data collection in multicenter clinical trials.

clinical trial, combination chemotherapy, compliance, evaluability, feasibility, lung cancer, quality-of-life assessment


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