Purpose: Informed consent is vital but challenging in genomic settings characterised by uncertainty and complexity. We have developed innovative online resources to support cancer patients who are considering genomic tumour profiling through a research program. This mixed-methods pilot study will investigate the feasibility/acceptability of the COnsent for GENomic Testing (‘CoGenT’) resources and explore their potential efficacy for improving the quality of informed consent, compared with usual care.
Sample and setting: This study will recruit adult patients with incurable, advanced and/or metastatic cancer (n=120) who are newly enrolled in an Australian genomics research program (‘CaSP’).
Procedures: After consenting to CaSP, participants will be randomised to three groups: Control – no additional materials; CoGenT Q&A – a structured list providing brief, accessible answers to common or important questions around tumour profiling; or CoGenT dynamic consent platform – a website providing layered information (incorporating the Q&A) and stepping users through giving informed consent. Intervention group participants will be asked to consider the CoGenT materials as potential additions to future consent processes. Participants will complete online surveys post-intervention and 3 months later. Some intervention group participants will also do qualitative interviews.
Results: Feasibility and acceptability will be assessed by proportion of intervention content utilised, other aspects of usage and engagement (via website analytics), and satisfaction items. Potential efficacy will be explored using measures of subjective understanding (Quality of Informed Consent scale), knowledge, decisional conflict, anxiety, decision satisfaction, and subsequent decision regret. We will thematically analyse qualitative interview data to understand patients’ feedback, perceptions and experiences of using the resources.
Conclusion and clinical implications: This pilot study will inform a larger-scale evaluation of the CoGenT resources. If results are positive, CoGenT materials could be implemented into consent protocols for cancer genomics studies and potentially adapted for clinical practice.