Impact on Quality of Life From Multi-modality Lung Cancer (PIONEER)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Lung Neoplasms
• Intervention / Treatment: Procedure: Surgery; Procedure: No surgery

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.

• Study Type: Observational
• Enrollment (Anticipated): 66

Contacts and Locations

• Study Contact: Name: Sally Taylor, PhD; Phone Number: 01619182446; Email: sally.taylor38@nhs.net
• Study Contact Backup: Name: Janelle Yorke, Prof; Email: janelle.yorke@nhs.net

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M139WL
    • Recruiting
    • Manchester University Foundation Trust- Wythenshawe
    • Contact: Matthew Evison, MD; Email: m.evison@nhs.net
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M68HD
      • Recruiting
      • Salford Royal NHS Foundation Trust
      • Contact: Seamus Grundy, MD; Email: seamus.grundy@srft@nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stage III N2 non small cell lung cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery; Surgery and systemic anti-cancer therapy (with or without radiotherapy) given in any order	Procedure: Surgery; Participants will be randomised to receive surgery as part of multi-modality treatment
No surgery; Radiotherapy and systemic anti-cancer treatment given in any order (with or without adjuvant immunotherapy if indicated).	Procedure: No surgery; Participants will be randomised to receive no surgery as part of multi-modality treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	6 months
Patients with N2 disease	Determine the proportion of patients with potentially resectable stage III N2 disease who are fit for surgery	20 months
Recruitment	Number of eligible patients recruited	20 months
Attrition	Number of patients lost to follow up	26 months
Treatment completion	The proportion of patients who complete their allocated treatment	6 months
Quality of life	Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)	6 months
Quality of life	Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30-LC13)	6 months
Quality of life	Short Form 36 (SF36)	6 months
EuroQOL 5D	Quality of life (EQ5D)	6 months
Service use/health economics	Study specific service use and health economics questionnaire	6 months
Mortality rates	Mortality rates collected by clinicians	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient experience	Interviews will be conducted with patients to explore their experiences in more detail.	26 months
Carer quality of life	Carer Quality of life- cancer questionnaire	6 months
Caregiver burden	Zarit Caregiver Burden	6 months
Caregiver anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	6 months

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust
• Collaborators: University of Manchester

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; non small cell lung cancer; Stage III N2; Multi-modality treatment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CFTSp176

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No