Patients in Clinical Cancer Trials : Understanding, Motivation and Hope

Abstract: The overall aim of this thesis was to study participants' understanding of clinical cancer trials,and their motivation for participation. Of particular interest was the question of whether thepatients hoped for a cure resulting from the trial. The thesis was based on four studies andused three methods: interviews, a questionnaire, and empirical bioethics. The results of Study Iindicated that the participants in phase 1 trials understood most of the information provided, butwere unaware of both the very small potential for treatment benefit, and the risk of harm. Patientsin phase 3 trials had a good understanding of the trial, except regarding side effects and their rightto withdraw. Some found it hard to ask questions and felt they needed more information (StudyIII). The participants in phase 1 trials were strongly motivated by the generally unrealistic hopefor therapeutic benefit (Study I). When the chances of a cure are minuscule, as for participantswith end-stage cancer in phase 1 trials, hope can play an important, positive role and offermeaning to one’s remaining life. However, hope for an unrealistic outcome could also deprivepatients of an opportunity to spend their remaining lives, as they would otherwise choose(Study II). The participants in phase 3 trials indicated that their motivation for participationwas multifaceted; the most common motivations included hope of therapeutic benefit, altruism,access to extra clinical examinations or better care, and a wish to repay society for the helpthey had received (Study III). After stratifying and analysing the motivation data by gender,age, education and previous experience of trial participation, males and those aged ≥65 yearswere significantly more motivated to participate out of a desire to reciprocate the help theyhad received, either because of a sense of duty or because their families or friends consideredthat they should attend (Study IV). In conclusion, the informed consent process seems to workrelatively well, with good results within most subgroups. However, patients with end-stagecancer who are participating in phase 1 trials are a vulnerable group as they have very littlepotential for treatment benefit coupled with a tangible risk of harm.