Abstract
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.
Highlights
Clinical cancer trials are crucial for the implementation of new treatments in the clinical setting, but it is crucial that patients are given the opportunity to make a well-informed decision about participation
When they were informed of a clinical trial that matched their form of cancer, they thought in most cases that it was a matter to participate, as they wanted to receive the best treatment and considered the trial to be an opportunity to achieve that
This study suggests that the decision to participate in clinical cancer trials is often immediate and guided by emotions, based on a trusting relationship with healthcare personnel rather than on careful reading of written information
Summary
Clinical cancer trials are crucial for the implementation of new treatments in the clinical setting, but it is crucial that patients are given the opportunity to make a well-informed decision about participation. The process of patients’ decision-making regarding clinical cancer trials has not yet been sufficiently studied. Another factor is the concept of clinical equipoise This is the notion that all treatment arms in a trial are effective, which is an underlying motive for randomisation. Whether this idea is acceptable to the patient can influence the decision to participate or not according to a study by Mills et al [11]. The decision-making process in clinical cancer trials has not yet been sufficiently studied and requires further investigation [12, 13]
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