The PIONEER Trial
Research type
Research Study
Full title
ImPact on QualIty Of life from multi-modality treatment for lung caNcEr: A randomised controlled fEasibility tRial of surgery versus no surgery as part of multi-modality treatment in potentially resectable Stage III-N2 NSCLC (The PIONEER Trial)
IRAS ID
274104
Contact name
Sally Taylor
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Duration of Study in the UK
2 years, 10 months, 0 days
Research summary
Summary of Research
We aim to explore how lung cancer patients and their family carers are affected by different types of cancer treatment. The information collected will help patients and their carers in the future to make decisions about the best treatment option for them. We are focusing on a particular type of lung cancer called Stage III N2. N2 means the cancer has spread just outside the lung to the lymph nodes. Around 2500 patients a year in the UK are diagnosed with this type of lung cancer. There are two main treatments available in the UK:
1. surgery PLUS chemo radiotherapy or chemotherapy
2. radiotherapy PLUS chemotherapy
Patients live for a similar length of time with either treatment option so it is difficult for patients and health professionals to know which treatment to choose. Research has not explored how the two different treatments offered affect individual patients and their carer. It is important to understand the impact of the treatment on:
• Symptoms
• Side effects
• Emotional well-being
• Day to day activities
Other research studies including N2 lung cancer patients have struggled with patient recruitment. This study design will show us if it is possible to run this type of research with this group of patients. Patients will be allocated at random (a process usually done by computer) to receive one of the two treatments options: 1) surgery PLUS chemo radiotherapy or chemotherapy 2) radiotherapy PLUS chemotherapy
Patients and carers will complete questionnaires and take part in interviews. Health professionals will also be asked to take part in interviews. These interviews will help us to understand their experience of recruiting patients to this study. The results of this study will help us decide if we should run a larger study in the future.Summary of Results
In this project we explored how patients with a particular type of lung cancer (Stage III-N2) and their family carers are affected by different types of cancer treatment. N2 means the cancer has spread just outside the lung to the lymph nodes. There are two main treatments available in the UK: 1. Chemotherapy and surgery 2. Chemotherapy and radiotherapy. Patients live for a similar length of time with either treatment option, so it is difficult for patients and health professionals to know which treatment to choose. In this study, we wanted to understand how the different treatments impacted on symptoms, side effects, emotional well-being, day to day activities and quality of life. Other similar studies have struggled to recruit patients so we wanted to see if this kind of study would be possible.The trial was delivered across eight UK sites. In total 276 patients were assessed for eligibility, 224 were ineligible. Forty-five were approached and 28 consented. Patients were randomly assigned to receive: 1) Chemotherapy and surgery or 2) Chemotherapy and radiotherapy. Patients and their carer completed questionnaires and took part in interviews to help us to understand the impact of the different treatments on their daily lives. Healthcare professionals were also interviewed to help us to understand their experience of recruiting patients to this study. The consent rate (62%) suggests that patients were generally happy with their treatment being randomised and no patients asked to change from their allocated treatment. Most patients reviewed for the study were considered to be ineligible following review at the multi-disciplinary team (MDT) meeting. The small number of eligible patients made recruitment difficult. Questionnaire completion rates were quite low, only 46% of patients completed questionnaires at the final time point. The findings from this study support the development of a follow-on trial but changes would need to be made to improve recruitment and questionnaire completion. Findings from interviews with patients, carers and MDT members were generally positive although the challenges of the trial were highlighted and areas for improvement suggested.
REC name
West of Scotland REC 3
REC reference
20/WS/0015
Date of REC Opinion
19 Feb 2020
REC opinion
Further Information Favourable Opinion