The culture of faith and hope

Abstract

Purpose Patients’ estimates of their chances of therapeutic benefit from participation in early-phase trials greatly exceed historical data. Ethicists worry that this “therapeutic misestimation” undermines the validity of informed consent. Patients and Methods We interviewed 45 patients enrolled in phase I or II oncology trials about their expectations of therapeutic benefit and their reasons for those expectations. We employed a phenomenological, qualitative approach with one primary coder to identify emergent themes, verified by 2 independent coders. Results Median expectations of therapeutic benefit varied from 50% to 80%, depending on how the question was asked. Justifications universally invoked hope and optimism, and 27/45 participants used one of these words. Three major themes emerged: (1) optimism as performative, that is, the notion that positive thoughts and expressions improve chances of benefit; (2) fighting cancer as a battle; and (3) faith in God, science, or both. Many participants described a culture in which optimism was encouraged and expected, such that trial enrollment became a way of reflecting this expectation. Many reported they had been told few patients would benefit and appeared to understand the uncertainties of clinical research, yet expressed high expected personal therapeutic benefit. More distressed participants were less likely to invoke performative justifications for their expectations (50% vs 84%; P = .04). Conclusion Expressions of high expected therapeutic benefit had little to do with reporting knowledge and more to do with expressing optimism. These results have implications for understanding how to obtain valid consent from participants in early-phase clinical trials.

A study of motivations and expectations of patients seen in phase 1 oncology clinics

“…An alternative explanation is that this subset of patients, despite having been exposed to this information, have chosen to maintain unrealistic hope. The concept of therapeutic optimism has been reported before,8, 14, 17 and phase 1 physicians have to walk a fine line between reiterating a patient's poor prognosis, which may be seen as patronizing, and not disregarding the importance of human hope 10, 11, 14…”

“…Research into patients' perceptions has generally focused on participants who have already enrolled or who are considering entry into early‐phase clinical trials, that is, after discussions have already taken place 8, 12, 13, 14, 15. Patients have demonstrated unrealistically high expectations of personal benefit or even a cure from these investigational agents 15, 16, 17.…”

“…Patients have demonstrated unrealistically high expectations of personal benefit or even a cure from these investigational agents 15, 16, 17. Much of the research has attributed these idealistic expectations to suboptimal patient‐physician communication and a patient‐based culture of needing to remain optimistic as treatment options diminish 11, 12, 14, 15, 18…”

Confronting Therapeutic Failure: A Conversation Guide

“…Some argue this hope is therapeutic and that it assists patients and their loved ones in coping with the emotional pain triggered by anticipating the final separation. Others take a bleaker, but more realistic, view, one that posits that talking only about anticancer treatment, instead of considering the big picture, distracts both the patient and the doctor from confronting their feelings of helplessness and grief and risks leaving patients and their loved ones unprepared for the final weeks or months [3][4][5][6][7][8]. In our essay, we reflect on our conversations with patients about therapeutic failure in the era of ever-expanding treatment options.…”

Faith, Hope And (No) Clarity

“…The problem arises when unrealistic optimism clouds an individual's assessment of the possible risks and benefits, when hope impedes effective consent. Recent papers from Sulmasy8 and Jansen et al 9 have identified a number of motivating issues that bear on participants attitudes to trials: the prevalence of faith (in individual physicians or science in general, in the miraculous or in a particular deity); and differences in the way that dispositional and unrealistic optimism play out in the consent process.…”