title: 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.
authors: Department of Medical Ethics and History of Medicine, University Medical Center Göttingen, Göttingen, Germany.
authors: J
authors: J
authors: Perry
authors: Department of Medical Ethics and History of Medicine, University Medical Center Göttingen, Göttingen, Germany.
authors: S
authors: S
authors: Wöhlke
authors: Department of General Practice, University Medical Center Göttingen, Göttingen, Germany.
authors: A C
authors: AC
authors: Heßling
authors: Department of Medical Ethics and History of Medicine, University Medical Center Göttingen, Göttingen, Germany.
authors: S
authors: S
authors: Schicktanz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D015179:Colorectal Neoplasms / Q000235:genetics / Q000628:therapy*; D032882:Comprehension; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009042:Motivation; D020360:Neoadjuvant Therapy; D026706:Paternalism; D057285:Precision Medicine; D036301:Qualitative Research; D035842:Research Subjects; D055990:Therapeutic Misconception / Q000941:ethics* / Q000523:psychology; D055815:Young Adult
chemical_list: D015415:Biomarkers
keywords: biomarkers; clinical trials; colon cancer; ethics; genetics; patient information