Experience of participating in a randomised controlled feasibility trial of surgery versus no surgery as part of multimodality treatment in stage III-N2 non-small cell lung cancer: PIONEER

INTRODUCTION: Multimodality treatment is recommended for potentially resectable stage III-N2 non-small cell lung cancer. However, no clear evidence states that surgery benefits survival and health-related quality of life (HRQoL). This multicentre (n=10, but 5 actively recruited) study explored experiences of patients, carers and multidisciplinary teams (MDTs) participating in a feasibility trial to inform the design of a phase III randomised trial with HRQoL as a primary outcome.

METHODS: Patient participants were randomised to receive multimodality treatment with or without surgery. Recruitment consultations were audio-recorded and analysed using content analysis. Patients and their informal carers completed weekly diaries. Semistructured interviews were conducted with declining and consenting patients, consented carers and MDT members. Interviews and diary data were analysed using framework analysis.

RESULTS: 28 patients and 9 carers participated in the PIONEER trial. 12 patients, 2 carers, 4 consent-declined patients and 20 clinicians were interviewed individually. Recruitment consultations of 4 declining and 12 consenting patients were recorded. 21 patients and 8 carers completed diary entries. All data sources were combined during analysis to create three overarching concepts: (1) Trial processes (treatment explanation, decline reasons, information needs, recruitment and eligibility, MDT engagement, patient factors and system issues); (2) Experience of PIONEER participation (daily impact physically and psychologically and coping mechanisms used) and (3) Considerations for a future trial (design, protocol, disease definitions, recruitment and engagement).

CONCLUSIONS: Patient and carer experience of participating in PIONEER was generally positive, though trial design improvements such as electronic questionnaires and diaries were recommended. Clinicians highlighted concerns regarding treatment equipoise, resectability assessment and the limited pool of eligible patients. These findings help explain the recruitment difficulties experienced and suggest that future research may be better directed towards pragmatic real-world study designs and improving treatment access for the large proportion of patients currently deemed ineligible.