Cancer patient decision making related to clinical trial participation: an integrative review with implications for patients’ relational autonomy

Abstract

Future research is needed to further elucidate the sociopolitical barriers and facilitators of clinical trial participation and to enhance ethical practice within clinical trial enrolment. This research will inform targeted education and support interventions to foster patients' relational autonomy in the decision-making process and potentially improve clinical trial participation rates.

Identifying components in consent information needed to support informed decision making about trial participation: An interview study with women managing cancer

“…It adds to the qualitative evidence on the process and experiences of decision making about clinical trial participation (Bell & Balneaves, 2015;Cox, 2002b;Locock & Smith, 2011a;Locock & Smith, 2011b;Pierce, 1993;Reynolds & Nelson, 2007;Snowdon et al, 2006;Thomas & Menon, 2013), and provides novel insight into the complexities of making trial decisions in the context of active illness management. The findings indicate women made trial participation choices within the context of treating and managing their cancer, rather than the context of an opportunity to participate (or not).…”

“…Patients and professionals have described informed consent for a trial as an empty ritual in which patients are provided with complex information that is difficult to understand and has little impact on their decision making (Armstrong et al, 2012;Lidz et al, 2004). Although the information provided during elicitation of informed consent has improved (Bjorn et al, 1999;Flory & Emanuel, 2004;Synnot et al, 2014), patients' understanding of consent remains suboptimal, leaving unmet patient needs (Bell & Balneaves, 2015;Brehaut et al, 2012a;Gillies et al, 2014;Moynihan et al, 2012). Previous studies show that patients possess poor knowledge and understanding about key aspects of trial processes and treatments (DixonWoods et al, 2007;Lidz et al, 2004;Pope et al, 2003) and find it difficult to integrate the information with their values and goals (Baker et al, 2013).…”

“…What this approach does not address explicitly is that patients are actively making decisions about their health and/or management of illness in the context of their lives, when offered trial participation opportunities ( Figure 1 -section 4). Little is known about how people perceive the clinical trial options in relation to standard care treatment options, how they reason about the trial and standard care options in relation to each other, and what helps or hinders their ability to make a reasoned decision about trial participation or not (Bell & Balneaves, 2015) An informed or reasoned decision is one based on accurate information about all options and their consequences, people's evaluations of these options in accordance with their values, and a choice made based on trade-offs between these evaluations (Bekker et al, 1999) (Jacobson et al, 2013) This study investigates the role of trial information in enabling women managing cancer to make trial choices and their support needs when making trial and treatment decisions at the same time.…”

Clinical Trial and Research Study Recruiters’ Verbal Communication Behaviors

“…Although researchers agree on the critical need for clinical trials and research studies in order to generate new knowledge on the most effective protocols and treatments for a wide variety of diseases and conditions (Bell & Balneaves, 2014;Friedman et al, 2014;Haddad, Chan, & Vermorken, 2015;Jenkins et al, 2013), clinical trial research is often compromised because of a low rate of accrual, even for studies deemed to be high priority (Albrecht et al, 2008;Haddad et al, 2015). The need for participation by members of minority and underserved populations is particularly acute Spiker & Weinberg, 2009;.…”

Nominalism in Medicine: the case of personalized medicine or precision medicine

“…7 Community oncologists often treat two thirds of their patients 8,9 with limited access to new research and related advances. In Europe, where the maximum of scientific knowledge and logistic framework is represented, the N o n -c o m m e r c i a l u s e o n l y percentage of patients involved in clinical trials is much higher: 37.1% accounts for in Italy.…”