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

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.

Nothing to lose: a grounded theory study of patients’ and healthcare professionals’ perspectives of being involved in the consent process for oncology trials with non-curative intent

“…This was linked to two core categoriesthe 'trusting relationship' between patient and professional who were united in 'fighting cancer'. Consistent with other study findings [6], both patients and professionals viewed the offer to participate in a clinical trial as the 'only hope in the room'. For some patients, it is hope, and continuing to believe that a cure is possible, that helps to bring some normality to their situation and enables them to cope with a bleak prognosis [35].…”

“…This process is crucial, allowing patients to make a voluntary and autonomous decision as to whether participation is right for them [4]. Similarly, it is imperative participants understand the uncertainty or clinical equipoise involved, with alternative opportunities made fully available to them [5] -such as supportive care within a palliative context [6]. As early phase trials involve patients nearing the end of life and often promise little clinical benefit, [7] decision making presents a highly complex and ethically challenging situation [8].…”

Patients’ and physicians’ disagreement on patients’ understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements

“…Our results indicate a gap between patients’ perceived understanding and physicians’ assessment of patient understanding. Studies have also shown that patients may base their decision to participate in a clinical trial on inadequate facts and misunderstandings [4, 29, 30], although they consider themselves to understand the trial information. In order to improve patient understanding of clinical trials, several kinds of interventions have been shown to be effective: enhanced consent documents, decisional aids and extended consent conversations seem to be of particular interest [9, 31].…”

“…The purpose of the oral and written patient information is to convey information that enables the patient to reach a level of understanding from which a decision can be taken based on study design, impact and risk-benefit combined with the patient’s individual preferences. In oncology as well as in other medical specialties, however, the trial information is often extensive and its communication is a complex process, which may indeed counteract the actual intent of complete information and full understanding [2–4].…”

Are cancer patients better off if they participate in clinical trials? A mixed methods study

“…Physicians and nurses found that a most difficult challenge was end-of-life patients eager to participate in all kinds of cutting-edge drug trials, often with an unrealistic hope for possible gain. The patients sometimes had high expectation concerning benefits [17][18][19][20][21][22], or believed the trials were miracles waiting to happen [23]. Though questionable, many physicians found it important to uphold hope and to support a belief in clinical trials because it can benefit patients and relatives.…”