Participation of elderly gynecological cancer patients in clinical trials
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Elderly patients are underrepresented in clinical trials in gynecological cancer, even though they are disproportionally often affected. This study aimed to evaluate the disposition and apprehension of elderly patients toward study participation.
112 elderly gynecological cancer patients (median age 70) were surveyed in a multicenter cross-sectional study. Besides fitness, state of disease, education and domestic situation, questions aimed at the general willingness to participate in a clinical trial. Personal reasons for refusal and anticipated advantages/disadvantages that might evolve from participation were inquired.
Willingness to participate in a clinical study was generally high (72%, 74/102). Reasons for potential study participation were: ‘better monitoring of the disease’ (67.1%), ‘better medical care’ (46.1%), ‘to help medical research’ (44.7%), ‘better medication’ (35.5%) and ‘because of my doctor’s recommendation’ (22.4%). Reasons for potential refusal were: ‘too time consuming’ (24.4%), ‘fear of side effects’ (21.8%), ‘misuse as experimental animal’ (18%), ‘long distance to clinic’ (14.1%) and ‘too little or unclear information’ (10.3%). 37.2% (29/78) of the patients stated that they had ‘no objection’ at all against study participation. The question if patients anticipated having a longer life due to study participation was answered with ‘yes’ or ‘rather yes’ in 42% (38/90); 28.9% answered ‘no’ or ‘rather no’ (29% undecided). No statistical significant relation between willingness to participate in a study and general fitness (p = 0.133), education (p = 0.122), age (p = 0.474) or domestic situation (p = 0.123) could be observed in a multivariate logistic regression model.
Elderly patients are generally willing to participate in clinical studies, in our cohort regardless of their fitness. Benefits of participation seem to be unclear among a majority of potential study participants. Therefore, it might be decisive to provide more general information regarding benefits and safety for elderly patients in a clinical trial.
KeywordsElderly Chemotherapy Gynecology Clinical trial
Medac Oncology (Grant number ID0EKBAG3598).
KP: study design, analysis of data and writing the manuscript (original draft); FT: organization of the survey, writing and approving the manuscript; GO-Ö: study design, design of questionnaire, organization of the survey and writing and approving the manuscript; RC: writing and approving the manuscript; CB: study design, design of questionnaire and writing and approving the manuscript; LO-F: writing and approving the manuscript; DG: writing and approving the manuscript; SK: figure design and writing and approving the manuscript; VM: writing and approving the manuscript; AS: statistical advice and analysis, and writing and approving the manuscript; BS: writing and approving the manuscript; JS: study design, design of questionnaire, organization of the survey and writing and approving the manuscript; SM: study design, design of questionnaire, organization of the survey and writing and approving the manuscript; LW: study design, organization of the survey, analysis of data and writing the manuscript (original draft).
Compliance with ethical standards
Conflict of interest
All authors declare that there are no conflicts of interest involved with the presented data. This study was supported by Medac Oncology without restriction in protocol or analysis.
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