Abstract

Objectives/purpose: The Evaluating Follow-up and Complexity in cancer Clinical Trials (EFACCT) study aimed to understand the nature of cancer clinical trial operational delivery, evaluating challenges and burdens of professionals and patients participating in cancer research studies. The study sought to develop a contextualised grounded theory elucidating situated challenges and complexity experienced at NHS sites in the UK.

Methods: The research used a mixed methods–grounded theory (MM-GT) design. The comprehensive, contextual evaluation combined evidence from quantitative and qualitative paradigms, using inductive and deductive methods. The study drew together multifaceted perspectives and values of 165 participants from six studies; Delphi, questionnaire, and interview studies, separated into patient and professional cohorts.

Results: The data generated new knowledge on the perceptions and experiences of key NHS stakeholders, leading to the conception of a Prismatic Coherence Model (PCM), a model evaluating and interrogating features of patient care, management and follow-up in complex network and transactional pathways existing within healthcare and clinical research delivery environments. PCM is an inclusive and responsive strategic approach, sensitive to context which embraces system complexity and transdisciplinarity, in order to advance opportunities for maximising population health.

Conclusion and clinical implications: The findings have the potential to support future research models, strategic planning, trial implementation and evaluation alongside the provision of system-based designs capable of supporting transdisciplinary approaches to advancing clinical cancer research and improving patient-centred outcomes.