How to improve informed consent processes in clinical trials with cancer patients: a qualitative analysis of multidisciplinary experts’ perspectives

URN zum Zitieren dieses Dokuments:: urn:nbn:de:bvb:355-epub-783312
DOI zum Zitieren dieses Dokuments:: 10.5283/epub.78331

Bernardi, Christine

; Wolff, Daniel

; Lüke, Florian

; Hies, Johannes ; Horn, Ruth ; Seitz, Frederike ; Heudobler, Daniel

; Herr, Wolfgang ; Herrmann, Anne

Lizenz: Creative Commons Namensnennung 4.0 International
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Veröffentlichungsdatum dieses Volltextes: 16 Dez 2025 05:53

Alternative Links zum Volltext:DOI Verlag

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Objective
According to legal and ethical obligations, patients must be thoroughly informed about the trial in which they could enrol, requiring them to consider and digest a significant amount of complex information. Many cancer patients feel overwhelmed which hinders their ability to make informed decision regarding their care. There is a need for further evidence-based strategies on how to improve both physician-patient-communication and informed consent (IC) documents in this area. We explored the views of experts from various disciplines on communication in IC processes in oncology.
Methods
Seventeen semi-structured interviews with multidisciplinary experts were conducted and analysed using framework analysis.
Results
Several experts stated that IC documents have become highly legalistic, often prioritizing the interests of sponsors and further institutions involved over patient understanding. IC conversations are considered essential, as many patients do not thoroughly read IC documents. Conducting an unbiased IC conversation in an understandable manner may be challenging for physicians because they often have vested interests in recruiting patients for trials. Introducing evidence-based checklists for IC conversations and involving nursing staff may assist in addressing practical issues patients may have, reduce anxiety, and increase consent rates. Strategies to improve IC documents include reducing potentially irrelevant information (e.g., on contraception), improving the adaptation of international consent forms to local settings and incorporating graphical abstracts and study flowcharts to offer brief and visually engaging summaries. Additionally, fostering open dialogue and involvement of all relevant stakeholders (including patient representatives from various sociodemographic backgrounds) in designing IC documents may enhance IC processes. Many experts expressed the need for further research on the needs of different target groups, such as individuals with a migrant background or visual or other impairments.
Conclusions
There is a significant gap between legal and ethical obligations related to IC and patients not being able to understand the abundance of unfamiliar, complex information provided to them. Evidence-based IC checklists, involving nursing staff and improved written IC materials may help improve communication in this area. Further interventional research is required to IC processes in oncology with the aim to provide optimal, patient-centred care.

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