title: Assessing the quality of life of patients in phase I and II anti-cancer drug trials: interviews versus questionnaires.
abstract: This paper discusses two different approaches to assessing quality of life in the context of cancer clinical trial participation. Drawing on empirical evidence from a study of patients' experiences of phase I and II anti-cancer drug trial participation, the paper demonstrates how different methods of collecting data about an individual's quality of life (questionnaires and interviews) can lead to alternative conclusions about patients' trial experience and the impact of trial involvement on their quality of life. Data obtained from the quality of life questionnaires interestingly revealed no statistically significant differences in any of the scores over time while in-depth interviews uncovered something of the psychological, emotional and social impact of taking part in a clinical trial from the perspective of the patient. The paper concludes by reflecting on some of the methodological issues that arise when assessing the quality of life of patients with a life threatening disease in clinical trials.
authors.affiliation: Faculty of Medicine and Health Sciences, University of Nottingham, Medical School Room B50, Nottingham, UK. karen.cox@nottingham.ac.uk
authors.forename: Karen
authors.initials: K
authors.lastname: Cox
mesh_terms: D000328:Adult; D000368:Aged; D017321:Clinical Trials, Phase I as Topic / Q000523:psychology*; D017322:Clinical Trials, Phase II as Topic / Q000523:psychology*; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000523:psychology; D011446:Prospective Studies; D011594:Psychometrics; D011788:Quality of Life / Q000523:psychology*; D035842:Research Subjects / Q000523:psychology*; D011795:Surveys and Questionnaires; D006113:United Kingdom