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

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ClinicalTrials.gov Identifier: NCT04540757
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : February 1, 2021
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
The Christie NHS Foundation Trust

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.

Condition or disease Intervention/treatment
Lung Neoplasms Quality of Life 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.

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Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Other
Time Perspective: Prospective
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)
Actual Study Start Date : November 25, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. Recruitment [ Time Frame: 20 months ]
    Number of eligible patients recruited

  3. Attrition [ Time Frame: 26 months ]
    Number of patients lost to follow up

  4. Treatment completion [ Time Frame: 6 months ]
    The proportion of patients who complete their allocated treatment

  5. Quality of life [ Time Frame: 6 months ]
    Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)

  6. Quality of life [ Time Frame: 6 months ]
    Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30-LC13)

  7. Quality of life [ Time Frame: 6 months ]
    Short Form 36 (SF36)

  8. Anxiety and depression [ Time Frame: 6 months ]
    Hospital Anxiety and Depression Scale (HADS)

  9. EuroQOL 5D [ Time Frame: 6 months ]
    Quality of life (EQ5D)

  10. Service use/health economics [ Time Frame: 6 months ]
    Study specific service use and health economics questionnaire

  11. Mortality rates [ Time Frame: 6 months ]
    Mortality rates collected by clinicians


Secondary Outcome Measures :
  1. Patient experience [ Time Frame: 26 months ]
    Interviews will be conducted with patients to explore their experiences in more detail.

  2. Carer quality of life [ Time Frame: 6 months ]
    Carer Quality of life- cancer questionnaire

  3. Caregiver burden [ Time Frame: 6 months ]
    Zarit Caregiver Burden

  4. Caregiver anxiety and depression [ Time Frame: 6 months ]
    Hospital Anxiety and Depression Scale (HADS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stage III N2 non small cell lung cancer
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540757


Contacts
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Contact: Sally Taylor, PhD 01619182446 sally.taylor38@nhs.net
Contact: Janelle Yorke, Prof janelle.yorke@nhs.net

Locations
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United Kingdom
Salford Royal NHS Foundation Trust Recruiting
Salford, Greater Manchester, United Kingdom, M68HD
Contact: Seamus Grundy, MD       seamus.grundy@srft@nhs.uk   
Manchester University Foundation Trust- Wythenshawe Recruiting
Manchester, United Kingdom, M139WL
Contact: Matthew Evison, MD       m.evison@nhs.net   
Sponsors and Collaborators
The Christie NHS Foundation Trust
University of Manchester
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04540757    
Other Study ID Numbers: CFTSp176
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Christie NHS Foundation Trust:
non small cell lung cancer
Stage III N2
Quality of life
Multi-modality treatment
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases