Lung NeoplasmsPIONEERNCT04540757
Impact on Quality of Life From Multi-modality Lung Cancer
An observational study of Lung Neoplasms and Quality of Life, run by The Christie NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Quality of Life
- What is being tested?
- Surgery and No surgery
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 25 Nov 2020to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage III N2 non small cell lung cancer
Who may be able to join
- 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
Who cannot join
- Patients unable to provide informed consent
- Patients who are not able to read and understand English
Trial locations and contacts
2 sites in 1 country.
Janelle Yorke, Prof contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Manchester University Foundation Trust- Wythenshawe
Manchester, M139WL
Matthew Evison, MD, m.evison@nhs.net
- Recruiting
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M68HD
Seamus Grundy, MD, seamus.grundy@srft@nhs.uk
About this study
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)
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:
- surgery PLUS chemo radiotherapy or chemotherapy
- 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.
Read the 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:
- surgery PLUS chemo radiotherapy or chemotherapy
- 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.
- Conditions
- Lung Neoplasms, Quality of Life
- Being tested
- Surgery, No surgery
- Keywords
- non small cell lung cancer, Stage III N2, Quality of life, Multi-modality treatment
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Participants will be randomised to receive surgery as part of multi-modality treatment
No surgeryProcedure or surgery
Participants will be randomised to receive no surgery as part of multi-modality treatment
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Surgery and systemic anti-cancer therapy (with or without radiotherapy) given in any order Receives: Procedure: Surgery | |
| No surgery | Radiotherapy and systemic anti-cancer treatment given in any order (with or without adjuvant immunotherapy if indicated). Receives: Procedure: No surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with N2 disease
Determine the proportion of patients with potentially resectable stage III N2 disease who are fit for surgery
Measured: 20 months
Recruitment
Number of eligible patients recruited
Measured: 20 months
Attrition
Number of patients lost to follow up
Measured: 26 months
Treatment completion
The proportion of patients who complete their allocated treatment
Measured: 6 months
Quality of life
Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)
Measured: 6 months
Quality of life
Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30-LC13)
Measured: 6 months
Quality of life
Short Form 36 (SF36)
Measured: 6 months
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS)
Measured: 6 months
EuroQOL 5D
Quality of life (EQ5D)
Measured: 6 months
Service use/health economics
Study specific service use and health economics questionnaire
Measured: 6 months
Mortality rates
Mortality rates collected by clinicians
Measured: 6 months
Secondary outcomes (4)
Patient experience
Interviews will be conducted with patients to explore their experiences in more detail.
Measured: 26 months
Carer quality of life
Carer Quality of life- cancer questionnaire
Measured: 6 months
Caregiver burden
Zarit Caregiver Burden
Measured: 6 months
Caregiver anxiety and depression
Hospital Anxiety and Depression Scale (HADS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start25 Nov 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540757
- Sponsor's protocol ID
- CFTSp176
- Acronym
- PIONEER
- Status last verified
- Feb 2022
- First submitted
- 6 Apr 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34266853
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04540757
- Acronym / sponsor ID
- PIONEER / CFTSp176
- Conditions
- Lung Neoplasms, Quality of Life
- Keywords
- non small cell lung cancer, Stage III N2, Quality of life, Multi-modality treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- surgery PLUS chemo radiotherapy or chemotherapy
- 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:
- surgery PLUS chemo radiotherapy or chemotherapy
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Procedure: SurgerySurgery and systemic anti-cancer therapy (with or without radiotherapy) given in any order |
| No surgery | – | Procedure: No surgeryRadiotherapy and systemic anti-cancer treatment given in any order (with or without adjuvant immunotherapy if indicated). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage III N2 non small cell lung cancer
Key inclusion criteria (6 listed)
- 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
- Carers of patients who have consented to take part in the randomised controlled trial
- Over the age of 18 years
Key exclusion criteria (2 listed)
- Patients unable to provide informed consent
- Patients who are not able to read and understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryParticipants will be randomised to receive surgery as part of multi-modality treatment | Procedure or surgery | Surgery |
| No surgeryParticipants will be randomised to receive no surgery as part of multi-modality treatment | Procedure or surgery | No surgery |
Primary outcome
Patients with N2 disease
Time frame: 20 months
Determine the proportion of patients with potentially resectable stage III N2 disease who are fit for surgery
Recruitment
Time frame: 20 months
Number of eligible patients recruited
Attrition
Time frame: 26 months
Number of patients lost to follow up
Treatment completion
Time frame: 6 months
The proportion of patients who complete their allocated treatment
Quality of life
Time frame: 6 months
Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)
Quality of life
Time frame: 6 months
Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30-LC13)
Quality of life
Time frame: 6 months
Short Form 36 (SF36)
Anxiety and depression
Time frame: 6 months
Hospital Anxiety and Depression Scale (HADS)
EuroQOL 5D
Time frame: 6 months
Quality of life (EQ5D)
Service use/health economics
Time frame: 6 months
Study specific service use and health economics questionnaire
Mortality rates
Time frame: 6 months
Mortality rates collected by clinicians
4 secondary outcomes
Patient experience
Time frame: 26 months
Carer quality of life
Time frame: 6 months
Caregiver burden
Time frame: 6 months
Caregiver anxiety and depression
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Derived from this study: PubMed 34266853Taylor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janelle Yorke, Prof contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms and Quality of Life, run by The Christie NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally Taylor, PhD (01619182446, sally.taylor38@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with N2 disease (time frame: 20 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04540757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.