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)
1 other identifier
observational
66
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2020
CompletedFirst Posted
Study publicly available on registry
September 7, 2020
CompletedStudy Start
First participant enrolled
November 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedFebruary 3, 2022
February 1, 2022
1.8 years
April 6, 2020
February 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
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
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS)
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 Outcomes (4)
Patient experience
26 months
Carer quality of life
6 months
Caregiver burden
6 months
Caregiver anxiety and depression
6 months
Study Arms (2)
Surgery
Surgery and systemic anti-cancer therapy (with or without radiotherapy) given in any order
No surgery
Radiotherapy and systemic anti-cancer treatment given in any order (with or without adjuvant immunotherapy if indicated).
Interventions
Participants will be randomised to receive surgery as part of multi-modality treatment
Participants will be randomised to receive no surgery as part of multi-modality treatment
Eligibility Criteria
Patients with stage III N2 non small cell lung cancer
You may qualify if:
- 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
You may not qualify if:
- Patients unable to provide informed consent
- Patients who are not able to read and understand English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Christie NHS Foundation Trustlead
- University of Manchestercollaborator
Study Sites (2)
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M68HD, United Kingdom
Manchester University Foundation Trust- Wythenshawe
Manchester, M139WL, United Kingdom
Related Publications (1)
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.
PMID: 34266853DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2020
First Posted
September 7, 2020
Study Start
November 25, 2020
Primary Completion
August 31, 2022
Study Completion
January 31, 2023
Last Updated
February 3, 2022
Record last verified: 2022-02