Enhancing the capacity to make decisions in borderline oncological situations. Development and piloting of a comprehensive intervention for vulnerable patients (Onco:cide)
Motivation
In addition to medical indication, voluntary consent, obtained after providing comprehensive information (informed consent), is a crucial ethical and legal need for receiving treatment or care in the healthcare industry. In routine clinical practice, situations repeatedly occur where it is uncertain if the criteria for obtaining valid informed consent, which includes providing comprehensible information to support the patient's ability to make decisions, are fulfilled. The complexity of medical information in the field of oncology poses a challenge in this regard. This is particularly relevant in in borderline clinical situations, in which a decision needs to be made over whether to proceed with (further) tumour-specific treatment together with patients based on thorough and comprehensive information. Conversely, the social and psycho-emotional challenges faced by tumour patients necessitate the need for material to be prepared in a way that is easily comprehensible for them.
Research on enhancing the decision-making capacity of individuals with learning disabilities and studies on enhancing patient comprehension of oncological research suggest that modifying medical information sheets and implementing additional support measures can enhance patients' decision-making abilities. Yet, it is uncertain if these therapies can be seamlessly integrated into routine oncological procedures in Germany and successfully applied to vulnerable patients. Furthermore, there is a dearth of applicable ethical and legal research to validate any alterations to existing information practices.
Goals
The objective of the collaborative initiative is to create and pilot a legally compliant and feasible multimodal intervention that is tailored to the individual needs of patients suffering from advanced bronchial, liver, or oesophageal cancer, with the goal of enhancing their decision-making capacity.
Methodology
The study can be characterised as a development and feasibility study according to the Medical Research Council's framework for complex interventions. In order to develop the intervention, we will conduct three key activities with the active participation of patients and their relatives.
To develop the intervention, 1) a realist review on the contextual (effect-)mechanisms that affect decision-making, 2) a qualitative study to explore relevant influencing factors on decision-making ability and requirements for the intervention, and 3) ethical and legal analyses of requirements for tools to support informed consent will be carried out with the participatory involvement of patients and relatives. Following that, a programme theory will be developed by consolidating the diverse evidence and viewpoints in a workshop involving professionals, patients, and family.
The new intervention will then emerge from this theory. A pre- and post-study will be undertaken to assess the clinical outcomes, process evaluation, and feasibility.