Socio-empirical and ethical analysis of patients' expectations and attitudes toward prognostic tests based on biomarkers in rectal cancer therapy
Final Report Abstract
With current standard treatment for locally advanced rectal cancer, physicians are confronted with a challenging issue in decision-making. They have to offer neoadjuvant therapy which, in some cases, increases the possibility of complete tumor resection but in other cases exposes patients to serious side effects without an actual benefit from treatment. For the physician, this can create personal and moral dilemmas in the assessment and weighing of increase in survival against the patient’s quality of life. The development of biomarkers raises hope for better stratification but also causes various concerns among ethicists, lawyers, physicians, and researchers. Some of these concerns are related to the quality and validity of the information generated with biomarkers. In addition, new questions arise concerning how prognostic health data might conflict with the patient’s right not to know. The increased focus on biological and genetic aspects of treatment creates the risk of losing sight of the psychological, family, and social aspects of cancer or other chronic diseases. Within our three-year project we examined moral and social attitudes of patients and their relatives toward prognostic tests with biomarkers and the assessment of their cancer treatment by means of socio-empirical analysis in longitudinal perspective. To fill the gap of empirical findings on the patient perspective in the context of biomarker research, we empirically examined rectal cancer patients’ expectations and experiences towards information preferences, their self-determination, and trust in the physician-patient relationship. Considering the methodological design, we combined non-participatory observation of the informed consent consultation (physician-patient; n=56) with up to three semi-structured interviews with each patient (n=41) included in our study during the six to eight months of treatment. Concerning patients’ expectations and attitudes, our detailed results show that most patients were overwhelmed by the complex medical information provided. Our results further highlight that only few patients thoroughly read and understood the informed consent materials before signing them and many patients had little understanding of their treatment or research participation. The findings also indicate that many patients misinterpreted the aim of the biomarker research study and participated because they attributed certain expectations to treatment, while not being aware of the aim of stratification. Some patients thought that they or their children would directly benefit from research participation. Other patients saw a personal advantage in study participation, linking their participation to more intensive supervision; e.g., additional blood samples were interpreted as "better treatment". Terms such as "individualized", "personalized", or "tailored treatment" were interpreted as the development of a new form of treatment which will heal more effectively. Further, the motivation of some patients to participate in the clinical study was based on notions of solidarity and role fulfillment. In contrast, non-treatment was considered an unacceptable option for most patients. Overall, the aim of biomarker research and personalized medicine remained rather abstract to most patients. Patients expected experts to break down the complexity for them. Patients compensated the complex information they did not understand with pragmatic trust. Furthermore, we identified different communication patterns, which physicians applied for motivating patients to take part in the research study. Some forms of these patterns tended to mislead patients’ understanding, while others could justifiably be applied in the consultation setting without undermining patients’ autonomy. This insight that the physician-patient communication has a strong influence on patients increases the importance to strengthen physicians’ ethically acceptable communication patterns regarding research participation. Our results indicate that for the clinical setting, the informed consent procedure should differentiate between informed consent for standard treatment and informed consent for clinical research. This would allow patients to make a clear distinction. Further, patients should be made more aware of the actual aim of the biomarker research study and its prognostic nature. Concerning future directions, we argue for a shared decision-making communication process for individualized medicine. The aim should be to provide and discuss patient-oriented information and also clarify values or preferences of the respective patient. This decision-making process could possibly be supported by a third party such as professional facilitators or family members. Support for the patient should be flexible as information needs change in the course of the illness and treatment. As stratified medicine also leads to the identification of "non-responders" in late cancer stages, options of "non-treatment" and the offer of palliative care should be incorporated by physicians and patients alike.
Publications
- Everything better than 50% is better than now. In: Dabrock, P., Braun, M., Ried, J. (Eds.): Individualized Medicine between hype and hope. Exploring ethical and societal challenges for healthcare, Lit-Verlag: Münster, 2012, pp. 111-135, ISBN 978-3-643-90298-6.
Hessling, A.
- What German experts expect from individualised medicine: problems of uncertainty and future complication in physician-patient-interaction. Clinical Ethics, Vol 7. 2012, Issue 2, pp. 86–93.
Hessling A., Schicktanz S.
(See online at https://doi.org/10.1258/ce.2012.12-001) - Wenn es persönlich wird in der „personalisierten Medizin“: Aufklärung und Kommunikation aus klinischer Forscher- und Patientenperspektive im empirisch-ethischen Vergleich. Ethik in der Medizin, Vol. 25. 2013, Issue 3, pp. 215–222.
Wöhlke S., Hessling A., Schicktanz, S.
(See online at https://doi.org/10.1007/s00481-013-0263-7) - Taking it Personally: Patients’ Perspectives on Personalised Medicine and its Ethical Relevance. In: Vollmann, J., Sandow, V., Wäscher, S. & Schildmann, J. (Eds.): The Ethics of Personalised Medicine. Critical Perspectives, Ashgate: Farnham, 2015, pp. 129-147.
Wöhlke, S., Perry, J. & Schicktanz, S.
(See online at https://doi.org/10.4324/9781315616209) - Why take part in personalised cancer research? Patients’ genetic misconception, genetic responsibility and incomprehension of stratification – an empirical-ethical examination. European Journal of Cancer Care, Vol. 26. 2017, Issue 5, Themed section: Cancer and work, e12563.
Perry J., Wöhlke S., Heßling A.C., Schicktanz S.
(See online at https://doi.org/10.1111/ecc.12563) - Physicians’ communication patterns for motivating rectal cancer patients to biomarker research: Empirical insights and ethical issues. Clinical Ethics, Vol 13. 2018, Issue 4, pp. 175–188.
Wöhlke S., Perry J., Schicktanz S.
(See online at https://doi.org/10.1177/1477750918779304)
