Assessing the quality of life of patients in phase I and II anti-cancer drug trials: interviews versus questionnaires
Section snippets
Defining quality of life
The concept of ‘quality of life’ was first introduced in the 1960s and 70s, when surveys were undertaken in the United States, to investigate the level of well-being of the population (Campbell & Converse, 1976). As a concept ‘quality of life’ became part of the debate on the goals of medical treatment in the late 1970s (De Haes & Van Knippenberg, 1985). A now rapidly expanding literature focuses on the evaluation of people's quality of life as it is affected by various disease states and
Findings
Common themes recurred throughout the interview material and it is clear that trial participants shared much in common no matter what their age, sex, disease site or the particular drug they were receiving. These themes have been labelled, ‘therapeutic alliance’, ‘trial burden’ and ‘searching for meaning’ to describe the way these patients’ accepted trial participation, dealt with the trial treatment and came to terms with trial conclusion. Each theme is made up of categories of data that
Discussion
Considered alone, the numerical data produced by the two quality of life questionnaires used in this study could easily give the impression that trial participation had a negligible impact on patients’ quality of life when considered at a group level. Of course the small sample size may well have been a significant contributory factor making it difficult to identify any statistically significant change. Furthermore, means that stay the same can mask increases and decreases at an individual
Conclusion
The observation that interviews provided evidence not offered by questionnaires does not mean, however, that these tools should be entirely disregarded. Due to limitations in sample size and lack of comparative data, it is very difficult to judge the quality of these tools from their use in this study. Questions can also be raised about the appropriateness of the quality of life questionnaires used in this study. This group of patients, while all having a diagnosis of cancer, were at the end
Acknowledgements
Thanks are due to Professor James Carmichael (CRC Academic Department of Clinical Oncology, University of Nottingham) and Professor Veronica James (School of Nursing, University of Nottingham). This research was funded by the Cancer Research Campaign (grant no. CP 1037/0101).
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