Impact of an educational intervention for advanced cancer patients referred for early phase clinical trials
A 2017 service evaluation identified a lack of information and knowledge among patients who were referred on to early phase oncology clinical trials (Hood, 2020). An educational booklet was developed to improve patients' knowledge and experience. To build upon this work, a patient co-designed website was developed. This study examined the impact, if any, of a patient co-designed educational intervention within the clinical pathway for patients who are referred for an early phase oncology clinical trial at an experimental cancer medicine centre (ECMC). Aims: 1. To understand the experiences of patients who have been referred to an ECMC for an early phase clinical trial pre- and post-intervention. 2. To investigate if the intervention reduced anxiety levels in newly referred patients. Method: A convergent mixed-methods design was used in this study, to collect quantitative and qualitative data in parallel. Outcomes: This study examined the experiences of advanced cancer patients who attended their initial research outpatient appointment to discuss the possibility of taking part in an early phase clinical trial and the impact of an educational resource.
Patient comprehension is an important component of the informed consent process within clinical research (Ruske et al, 2021). Nevertheless, studies have indicated that clinical trial patients remember little of the information that is discussed during the informed consent process, and their level of understanding around essential information is often overestimated (Ruske et al, 2021). Systematic reviews into the informed consent process have outlined that the level of patient knowledge gained from informed consent is frequently inadequate and that further educational interventions need to be developed (Castillo et al, 2021).
There has been longstanding criticism of informed consent within clinical research, and it is often seen as a process that meets only the regulatory requirements imposed, rather than a truly ethical process that produces informed and voluntary participation within clinical research (Wexler et al, 2022).
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