Aims: As genomic testing is increasingly integrated into precision oncology, ensuring patients can make informed testing decisions is critical to delivering ethical, person-centred care. This pilot study investigated the acceptability and feasibility of a dynamic consent platform and Q&A resource designed to support Consent for Genomic Testing (CoGenT) and explored potential efficacy for improving quality of informed consent, compared with usual care.
Methods: We recruited 120 patients (meeting the planned target) with advanced/incurable cancer who had just consented to join a research program providing tumour genomic profiling. Participants were randomised to control (no additional materials) or intervention. The intervention group received access to the CoGenT dynamic consent platform, which guided users through informed consent using layered information, incorporating a structured Q&A addressing common/important questions. Participants were asked to consider the CoGenT intervention hypothetically as a component of future genomic consent. An online survey assessed acceptability, quality of informed consent, decisional conflict, and knowledge. Qualitative interviews with 18 intervention participants underwent thematic analysis.
Results: 90% of intervention participants accessed CoGenT and 75% completed the survey. Of these, 94% reported learning new information, 92% found CoGenT clear and easy to understand, and 94% would recommend its use. Interviews indicated that participants were strongly motivated to undergo testing to identify potential targeted therapies and valued CoGenT for ‘personalising’ consent (e.g., helping “get the information I needed in a way that spoke to me as an individual”). Potential efficacy outcomes, including quality of informed consent, decisional conflict, and knowledge, did not significantly differ between groups.
Conclusions: In this pilot study with advanced cancer patients recently consented to tumour genomic profiling, a dynamic consent platform and Q&A resource was acceptable, feasible and valued but did not demonstrate efficacy in improving consent outcomes beyond usual practice. Further research is needed to ascertain efficacy in additional settings.