Do cancer patients fully understand clinical trial participation? A pilot study to assess informed consent and patient expectations |
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| Authors: | Ricardo J Wray Jo Ellen Stryker Eric Winer George Demetri Karen M Emmons |
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| Institution: | (1) Cancer Trials Australia, Parkville, Victoria, Australia;(2) Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia;(3) Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, Locked Bag 1, A’Beckett Street, Melbourne, Victoria, 8006, Australia |
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| Abstract: | Background. Accepted practices of informed consent often result in suboptimal patient understanding of research studies.Methods. This pilot study aimed to assess trial-specific tailored materials, compared to a widely used generic booklet about clinical
trials, randomly assigned to 118 candidates for cancer clinical trials. Study outcomes were: satisfaction with decision-making;
satisfaction with materials; and subjective understanding of the clinical trial.Results. There were no major differences between groups. Participants rated tailored materials higher as a useful reference.Conclusions. Trial-specific materials hold utility for reference during clinical trials. Studies of informed consent are feasible, although
important factors limit research. |
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