Clinical trial NCT04540757: Impact on Quality of Life From Multi-modality Lung Cancer
Official 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasms
Quality of Life
Keywords: non small cell lung cancer
Stage III N2
Quality of life
Multi-modality treatment
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2020-09-07
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage III N2 non small cell lung cancer

Brief summary: The investigators aim to explore how lung cancer patients and their family carers are affected by different types of cancer treatment. The investigators 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. There are two main treatments available in the UK for this type of lung cancer:

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. It is important to understand the impact of the treatment on patients in their daily lives. Patients will be allocated at random to receive one of the two treatments options. Patients and carers will complete questionnaires and take part in interviews. The results of this study will help the investigators decide if a larger study should be conducted in the future.

Detailed description: The investigators 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. The investigators 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 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 the investigators to understand their experience of recruiting patients to this study. The results of this study will help the investigators decide if a larger study should be conducted in the future.

Eligibility criteria: Inclusion Criteria:

* Patients with potentially resectable T1-4 N2 M0 NSCLC who have received an multi disciplinary team recommendation for multi-modality treatment
* Multi disciplinary team consensus that the patient has adequate physiological reserve for multi-modality treatment and either treatment arm is both technically and clinically appropriate
* Patient over the age of 18 years

Carer criteria:

* Carers of patients who have consented to take part in the randomised controlled trial
* Over the age of 18 years

Exclusion Criteria:

* Patients unable to provide informed consent
* Patients who are not able to read and understand English

Primary outcomes:
measure: Patients with N2 disease
timeFrame: 20 months
measure: Recruitment
timeFrame: 20 months
measure: Attrition
timeFrame: 26 months
measure: Treatment completion
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Anxiety and depression
timeFrame: 6 months
measure: EuroQOL 5D
timeFrame: 6 months
measure: Service use/health economics
timeFrame: 6 months
measure: Mortality rates
timeFrame: 6 months
Secondary outcomes:
measure: Patient experience
timeFrame: 26 months
measure: Carer quality of life
timeFrame: 6 months
measure: Caregiver burden
timeFrame: 6 months
measure: Caregiver anxiety and depression
timeFrame: 6 months
Other outcomes:
Locations:
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Greater Manchester
city: Manchester
country: United Kingdom
facility: Manchester University Foundation Trust- Wythenshawe
Study officials:
References:
citation: Taylor S, Yorke J, Tsim S, Navani N, Baldwin D, Woolhouse I, Edwards J, Grundy S, Robson J, Rhodes S, Gomes F, Blackhall F, Faivre-Finn C, Evison M. Impact on quality of life from multimodality treatment for lung cancer: a randomised controlled feasibility trial of surgery versus no surgery as part of multimodality treatment in potentially resectable stage III-N2 NSCLC (the PIONEER trial). BMJ Open Respir Res. 2021 Jul;8(1):e000846. doi: 10.1136/bmjresp-2020-000846.