Abstract
Feasibility issues of quality-of-life (QL) assessment in cancer clinical trials have been discussed mainly in regard to compliance with QL questionnaires. In the case of an acceptable compliance, it is usually taken for granted that questionnaires received at the office for central data management have been filled in according to the rules and guidelines stated in the study protocol. The question whether local conditions of data collection might have a substantial influence on patients' QL estimation is not considered. In clinical experience, QL assessment in cancer patients may be a supportive intervention by itself, increasing awareness to QL issues in both patients and staff. To elaborate further on this question and the potentially interfering effects on patients' self-estimation we asked the nurses involved in the QL assessment of a randomized trial in small-cell lung cancer to describe their experiences. Meetings between the nurses collecting the data and the study coordinator took place on a regular basis. The detailed protocols of these meetings are used to describe qualitatively the possible influence of such unsystematically assessed factors on compliance and data quality. Implications regarding QL methodology are discussed.
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References
Aaronson NK (1992) The quality of life of patients in cancer clinical trials: common problems and common sense solutions. Eur J Cancer 28:1304–1307
Aaronson NK, Bakker W, Stewart AL, et al (1987) Multidimensional approach to the measurement of quality of life in lung cancer clinical trials. In: Aaronson NK, Beckmann J (eds) The quality of life of cancer patients. Raven Press, New York, pp 101–109
Bernhard J (1992) “Lebensqualität” in onkologischen Therapiestudien. Konzepte, Methodik und Anwendung am Beispiel des kleinzelligen Bronchuskarzinoms. Lang, Bern Frankfurt a M New York
Breetvelt IS, Dam FS van (1991) Underreporting by cancer patients: the case of response-shift. Soc Sci Med 32:981–987
Deyo RA, Diehr P, Patrick DL (1991) Reproductibility and responsiveness of health status measures. Statistics and strategies for evaluation. Controlled Clin Trials 12 [Suppl]:142–158
Greenberg ER, Chute CG, Stukel T, et al (1988) Social and economic factors in the choice of lung cancer treatment: a population-based study in two rural states. N Engl J Med 318:612–617
Hürny C, Piasetsky E, Bagin R, Holland JC (1987) High social desirability in patients being treated for advanced colorectal and bladder cancer. J Psychosoc Oncol 5:19–29
Hürny C, Bernhard J, Joss R, et al, for the Swiss Group for Clinical Cancer Research (1992) Feasibility of quality of life assessment in a randomized phase III trial of small cell lung cancer. A lesson from the real world. Ann Oncol 3:825–831
Richardson JL, Marks G, Levine A (1988) The influence of symptoms of disease and side effects of treatment on compliance with cancer therapy. J Clin Oncol 6:1746–1752
Sugarbaker PH, Barofsky I, Rosenberg SA, Gianola FJ (1982) Quality of life assessment of patients in extremity sarcoma clinical trials. Surgery 91:17–23
Zerssen D von (1986) Clinical selfrating scales (CSRS) of the Munich Psychiatric Information System (PSYCHIS München). In: Sartorius N, Ban TA (eds) Assessment of depression. Springer, Berlin Heidelberg New York, pp 270–303
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Bernhard, J., Gusset, H. & Hürny, C. Quality-of-life assessment in cancer clinical trials: an intervention by itself?. Support Care Cancer 3, 66–71 (1995). https://doi.org/10.1007/BF00343923
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DOI: https://doi.org/10.1007/BF00343923