• Pia Dellson, Kerstin Nilsson, Helena Jernström, and Christina Carlsson.
• Department of Clinical Sciences, Division of Oncology and Pathology, Lund University and Skåne University Hospital, Barngatan 4, 221 85, Lund, Sweden. pia.dellson@med.lu.se.
• Trials. 2018 Sep 29; 19 (1): 528.

BackgroundClinical cancer trials are crucial for the implementation of new treatments in the clinical setting, but it is equally crucial that patients are given the opportunity to make a well-informed decision about participation. The inclusion process is complex, including both oral and written information about the trial. The process of patients' decision-making regarding clinical cancer trials has not yet been sufficiently studied. This interview study aims to explore the process of patients' reasoning regarding the decision to participate in a clinical cancer trial.MethodsThe study is based on 27 individual face-to-face interviews with patients who had decided to participate in a clinical cancer trial. The interviews were audio-recorded and transcribed verbatim and then analysed using inductive content analysis.ResultsContent analysis revealed 17 subthemes grouped into five themes: (1) an unhesitating decision to participate; (2) a decision based on flimsy grounds and guided by emotion; (3) feeling safe and secure with my decision; (4) faced with a choice versus what choice do I have? and (5) hoping for help while helping others. The decision to participate in a clinical cancer trial was often immediate and guided by emotions, based on a trusting relationship with healthcare personnel rather than on careful reading of written information. Palliative patients, in particular, sometimes had unrealistic beliefs about the effectiveness of the trial treatment.ConclusionsIt is vital that the decision to participate in a clinical cancer trial is preceded by an honest dialogue about possible positive and negative effects of the trial treatments, including other options such as supportive care in the palliative setting. Our findings also raise the questions of how important written information is for the decision-making process and also whether genuine informed consent is possible. To reach a higher degree of informed consent, it is most important that the oral information is given in a thorough and unbiased manner.

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