Patients’ reasoning regarding the decision to participate in clinical cancer trials: an interview study

Including cancer patients in clinical trials is crucial in order to accelerate the process of implementing new treatments in the clinical setting. However, it is equally important that the patients are able to understand the prerequisites of a clinical trial and are given the opportunity to make a well-informed decision about participation. Patient information, which is typically oral as well as written, has the major aim of achieving informed consent to guarantee patients’ autonomy and protect patients from potential harm as stated in the Declaration of Helsinki [1]. However, the written information is complex and needs to consider a large number of issues, e.g. the rationale for different treatment principles and regimes, treatment alternatives, planned procedures, potential risks and benefits, time implications, the right to withdraw at any time without explanation and a number of legal issues. The written information can therefore be extensive and difficult to understand [2, 3]. Support, such as decision aids for patients, guidelines for professionals and standard question guides for physicians, may improve patients’ understanding [4–6]. Several studies have indicated that although patients are generally satisfied with the consent process, understanding is suboptimal of, for example, study aims, treatment risks and benefits, randomisation and research aspects [7–9]. A number of factors have been identified that affect patients’ decision-making regarding clinical cancer trials. Two of the most common factors, particularly in palliative settings, are hope for potential treatment benefit, as well as altruistic motives, as reported by Harrop et al. [10]. Another factor is the concept of clinical equipoise. This is the notion that all treatment arms in a trial are equally effective, which is an underlying motive for randomisation. Whether this idea is acceptable to the patient can also influence the decision to participate or not according to a study by Mills et al. [11]. However, the decision-making process in clinical cancer trials has not yet been sufficiently studied and requires further investigation [12, 13].

A review by Bell and Balneaves [14] identified three types of factors influencing cancer patients’ decision-making for participation in clinical trials: personal; social; and system factors. However, how these factors interact and influence patients’ decision-making process is insufficiently studied and understood. More extensive and deeper understanding of the patient reasoning process regarding participation in clinical cancer trials may provide new insights into patients’ views and vulnerability as well as other factors, both internal and external [15]. This understanding will also benefit patients and guide healthcare professionals in the planning and delivery of future treatments. Therefore, the study aim has been to explore patients’ reasoning regarding the decision to participate in a clinical cancer trial. The method used was individual face-to-face interviews with patients who had decided to enter a clinical cancer trial and the data were analysed with inductive content analysis.

A qualitative design [16] was used to explore patients’ reasoning on participation in a clinical cancer trial. Since the intention was to understand patient perspectives, the data collection method consisted of open-ended face-to-face interviews [17]. The inductive content analysis method was used to analyse the data since this method allows analysis at varying levels of abstraction and interpretation [18].

The study identified 17 subthemes grouped into five major themes. The most striking finding was that many of our informants described the decision to participate as instant, taken even before they had been given full information about the clinical trial in question. The decision was guided more by emotion than conscious deliberation. The patients stated that the decision to participate was obvious, immediate and easy. It was not guided by the written or oral information on the trial, which they only skimmed through or registered fragments of, but rather based on a positive gut feeling.

This immediateness of patients’ decision-making process has, to our knowledge, rarely been described before [20] and it can be understood through theories in cognitive psychology. Extensive work has been done regarding theories of dual processing in decision-making, where fast intuitive and emotion-driven System 1 processes are contrasted with the slow analytic procedures of System 2 [21, 22]. It is assumed that the fast System 1 processes cue default intuitive judgements, that in some cases are later endorsed by the analytic System 2. This is in accordance with our findings, where the patients described an immediate decision to participate, based on hopeful and positive feelings towards the physician and research in general. This fast, emotional process was sometimes followed by a slower cognitive process. Here, they examined the oral and written clinical trial information more closely and discussed their decision with others to confirm it. However, some did not find this slower process necessary but were satisfied with their immediate decision. This fact points to the importance of not regarding the decision-making process as solely, or even primarily, a cognitive process. A study by Yang et al. confirms the importance of emotions in cancer patients’ decision-making, presenting data that emotions play a significantly greater role for them compared to a representative national sample [23]. Taken together, this suggests that written information may be less important for the decision process than is generally assumed.

In some cases, the referring physician had taken up the issue of clinical trials before the patient arrived at the oncology department; this may have contributed to a faster decision-making process there, as the patient had time to consider the question beforehand. Furthermore, epidemiological studies have shown that pre-notification significantly increased participation in clinical trials [24]. This is in line with other research [25] and points to the importance of regarding informed consent not as a single event but rather as a multistage process.

Another interesting finding is that the patients attached great importance to the relational aspects of the decision-making process, referring to the fact that they trusted the physicians, the research nurses and researchers. This trust made them feel safe and secure with their decision to participate in the clinical trial, which is in line with previous studies [26, 27]. Another important aspect was that trial participation would result in closer follow-up and more direct access to care, through the research nurse in particular. Many of our patients were also convinced that the clinical trials were based on certain assumptions about the positive effects of the drugs being tested and, despite information about the risk of side effects, patients valued the chance of receiving effective treatment for their cancer so highly that they accepted the risk of side effects. This finding is in accordance with Madsen et al. [28] who found that trial participants tended to concentrate on possible differences in treatment effects and often considered the experimental treatment option to be superior. This misconception is an important issue to address in order to achieve informed consent based on a correct understanding of the trial design.

Some patients described not actually having the choice to decline, either because they felt they had to rely on the physician’s knowledge, which they considered more expert than their own, or due to the fact that participating in the trial was the only possibility to access further treatment for their form of cancer. These patients were often in a palliative situation. Under a serious life threat, there may be even more difficulties in cognitively processing information about a clinical trial. Furthermore, some patients had an unrealistic belief that the treatment was curative due to not understanding that the cancer situation was palliative. Again, this raises the question as to whether truly informed consent actually exists under these circumstances [29]. Moreover, many physicians find it difficult to bring up the issue of palliative care as a treatment option, due to fear of taking away the patient’s hope, thus tending to avoid the subject altogether [30]. It is therefore vital that the decision to participate in a clinical trial is preceded by an honest discussion about the possible positive and negative effects, including other existing treatment options where one of the options described should be palliative or best supportive care. This approach is also suggested by Godskesen [31] and is of great importance since supportive care may actually lead to increased life expectancy with better symptom control than a continued tumour-directed treatment, as shown in a lung cancer study by Temel et al. [32].

Our most expected finding was the theme ‘Hoping for help while helping others’, which is in accordance with other studies, where these aspects were the main reasons for cancer patients to participate in a clinical trial [10, 33–35]. The patients were grateful to previous patients who had contributed to the current treatments and wanted to make the same effort for future patients. They considered themselves part of a context in which different contributors cooperate for the common good. This reasoning can be considered a kind of coping strategy aimed at making a difficult situation more meaningful, as described earlier by Godskesen et al. [36].

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. It is vital that the decision to participate is preceded by an honest dialogue about the possible positive and negative effects, including other options such as supportive care in the palliative setting. Our findings may even raise the question of whether genuine informed consent is possible and also of how important written information is for the decision-making process. In conclusion, to reach a higher degree of informed consent, it is of great importance that oral information is given in a thorough and unbiased manner.