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

@article{perry2026experience,
  title = {{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}},
  author = {Melissa Betty Perry and Ashleigh Ward and David R Baldwin and Fiona Blackhall and Charlotte Eastwood and John Edwards and Matthew Evison and Corinne Faivre-Finn and Seamus Grundy and Emily Harris and Neal Navani and Sarah Rhodes and Jonathan Robson and Selina Tsim and Paul Van Schil and Ian Woolhouse and Janelle Yorke and Sally Taylor},
  journal = {BMJ Open Respiratory Research},
  year = {2026},
  month = oct,
  doi = {10.1136/bmjresp-2026-004632},
  url = {https://doi.org/10.1136/bmjresp-2026-004632},
  note = {CC BY 4.0},
}

TY  - JOUR
TI  - 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
AU  - Melissa Betty Perry
AU  - Ashleigh Ward
AU  - David R Baldwin
AU  - Fiona Blackhall
AU  - Charlotte Eastwood
AU  - John Edwards
AU  - Matthew Evison
AU  - Corinne Faivre-Finn
AU  - Seamus Grundy
AU  - Emily Harris
AU  - Neal Navani
AU  - Sarah Rhodes
AU  - Jonathan Robson
AU  - Selina Tsim
AU  - Paul Van Schil
AU  - Ian Woolhouse
AU  - Janelle Yorke
AU  - Sally Taylor
PY  - 2026
DA  - 2026/10/26
JO  - BMJ Open Respiratory Research
DO  - 10.1136/bmjresp-2026-004632
UR  - https://doi.org/10.1136/bmjresp-2026-004632
AB  - 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.
SN  - 2052-4439
ER  -