Patients in Clinical Cancer Trials. Information, Understanding and Decision-Making

Abstract

AbstractThe informed consent process for clinical trials (CTs) is complex. Patients must be able to understand the information given to be able to make an informed decision. This thesis aimed to explore patients’ and patient representatives’ views, factual knowledge, and perceived understanding of patient information in clinical cancer trials, and to investigate how patients’ understanding may be correlated to their decision-making and their physicians’ assessment of their understanding.In Studies I and II, focus group interviews were conducted in which patient representatives with experience of breast and colorectal cancer respectively examined informed consent documents (ICDs). Their suggestions for improving breast cancer ICDs were validated by an independent group of patient representatives. These results were then presented as a guide for writing ICDs. The main conclusion was that ICDs need better graphic design in order to facilitate readers’ orientation in and processing of information. All ICDs should therefore be designed by a team including patient representatives, professional writers and graphic designers.Study III was a questionnaire pilot study which showed that patients consider their understanding to be higher than the patient understanding assessed by their informing physicians. Neither the patients’ nor their physicians’ ratings correlated with the patients’ factual knowledge, as measured by the instrument Q-PUR. This pilot study needs validation in an independent setting. The main conclusion was that the informed consent process would benefit from informing physicians acquiring and applying specific communication skills in order to assess patient understanding more precisely, the better to tailor the information given to the needs of the individual patient.In Study IV, patients who had decided to participate in a CT were interviewed individually about how they reasoned when making this decision. The results showed that the decision to participate was often immediate and guided by emotions and a trusting relationship with health care professionals. Important factors for the decision-making process included knowledge of the right to withdraw from the CT and explicit comparisons between the treatment alternatives included, and also those not included, in the CT. Patients in palliative situations were sometimes unaware of the fact that their disease was no longer curable. For CTs in the palliative setting, the treatment alternative ‘best supportive care’ should therefore be stated as one option. The main conclusion was that these factors need to be addressed specifically in the informed consent conversations.The overall conclusions are that better graphic design of ICDs is essential and that informing physicians must acquire and apply specific communication skills in order to improve the informed consent process