Abstract
BACKGROUND: Understanding experiences of diagnostic investigation for any new screening modality is important to inform the development of pathways for future implementation. We explored experience of diagnostic work-up within the NHS in people with a cancer signal detected result from a blood-based multi-cancer early detection (MCED) screening test in the NHS-Galleri trial (NCT05611632). METHODS: A subset of 41 participants with a cancer signal detected result (with/without a cancer diagnosis), were interviewed 6-months after their result. Participants described their experiences of diagnostic investigation within the NHS. Reflexive Thematic Analysis was used. FINDINGS: The journey through the period of diagnostic investigation was extremely varied since this was dependent on the predicted cancer site(s). Participant narratives demonstrated wide variation in the required tests, number of contacts with healthcare staff and duration of the whole process. Five themes were interpreted from participants' narratives: i) Feeling prepared for procedures; ii) Needing to advocate; iii) Needing to self-navigate: iv) Speed of the diagnostic process and having to wait; v) Reaching 'the end' of diagnostic work-up. INTERPRETATION: If MCED screening is implemented in future, it will be important to carefully consider implementation of appropriate diagnostic investigation for patients who have a cancer signal detected. We recommend minimising the length of the diagnostic testing period, offering patient navigation and formulating clear plans for what happens at the end of the patient journey. While our findings highlight important considerations to support positive experiences for those having follow-up tests after a cancer signal detected result, they also have broader application for improvement of cancer diagnostic pathways more generally. FUNDING: This work was funded and sponsored by GRAIL Bio UK, Ltd. as a sub-study within the NHS-Galleri trial. GRAIL funded the costs of the data collection as well as staff salaries through a contract with King's College London/Queen Mary University of London.