Why take part in personalised cancer research? Patients’ genetic misconception, genetic responsibility and incomprehension of stratification-an empirical-ethical examination

Abstract

Therapeutic misconception is a well-known challenge for informed decision-making for cancer research participants. What is still missing, is a detailed understanding of the impact of "personalised" treatment research (e.g. biomarkers for stratification) on research participants. For this, we conducted the first longitudinal empirical-ethical study based on semi-structured interviews with colorectal cancer patients (n = 40) enrolled in a biomarker trial for (neo)adjuvant treatment, analysing the patients' understanding of and perspectives on research and treatment with qualitative methods. In addition to therapeutic misconception based on patients' confusion of research and treatment, and here triggered by misled motivation, information paternalism or incomprehension, we identified genetic misconception and genetic responsibility as new problematic issues. Patients mainly were not aware of the major research aim of future stratification into responders and non-responders nor did they fully acknowledge this as the aim for personalised cancer research. Thus, ethical and practical reflection on informed decision-making in cancer treatment and research should take into account the complexity of lay interpretations of modern personalised medicine. Instead of very formalistic, liability-oriented informed consent procedures, we suggest a more personalised communication approach to inform and motivate patients for cancer research.

Physicians’ communication patterns for motivating rectal cancer patients to biomarker research: Empirical insights and ethical issues

“…This is because it seems to lead to patients assuming that biological relatives and their own children may benefit from their research participation, thus triggering genetic misconception. 12,52,70,71 Patients, according to our empirical study, tend to misunderstand this indirect form of argumentation as a plea to participate. Motivation for research was here triggered by means of patients' values (care for one's loved ones), while an informative physician-patient model was often observed.…”

“…The third and last interview was conducted, if the patient still was available and willing, after on average 28 weeks of treatment when chemotherapy was (almost) completed. Figure 1 gives an overview of the timing and sequencing of data collection over the time of the patients' treatment procedure f (for details on the study also see Perry et al 12 ). In order to ensure data protection, we recruited patients with the help of the clinic's administration office.…”

“…Some patients may not understand or misunderstand the aims of the respective research. 12,51,52 All of these implications regarding the conduct of research and research participation may have an effect on how physicians communicate the aims to patients and how they motivate them to participate.…”

“…Some socio-empirical ethical studies have argued that both the ethical concept and the current, often legalistic, practice of informed consent should be adapted to the complexity of the clinical research environment. [12][13][14][15][16][17][18][19] Furthermore, qualitative studies and quantitative surveys indicate that many patients wish for more patient-centred decision making or shared decision making (SDM) supporting their self-determination and wish for more detailed information. [20][21][22][23][24][25][26][27][28][29] Communication processes are highly relevant to research recruitment.…”

“…34 In a primary analysis of the data at hand, focusing on patients' misconceptions regarding research participation, we perceived typical and recurring communication patterns when physicians recruited patients for their biomarker study. 12 Thus, the aim of this secondary analysis is to focus on these communication patterns in a more systematic and analytical manner. This secondary analysis, therefore, sets out from the question of how new forms of communication patterns are becoming necessary for research participation in the course of technological advances and new forms of treatment stratification.…”