Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-25 @ 4:13 PM
Study NCT ID:
NCT04540757
Status:
UNKNOWN
Last Update Posted:
2022-02-03
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact on Quality of Life From Multi-modality Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-09-03', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients with N2 disease', 'timeFrame': '20 months', 'description': 'Determine the proportion of patients with potentially resectable stage III N2 disease who are fit for surgery'}, {'measure': 'Recruitment', 'timeFrame': '20 months', 'description': 'Number of eligible patients recruited'}, {'measure': 'Attrition', 'timeFrame': '26 months', 'description': 'Number of patients lost to follow up'}, {'measure': 'Treatment completion', 'timeFrame': '6 months', 'description': 'The proportion of patients who complete their allocated treatment'}, {'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)'}, {'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30-LC13)'}, {'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'Short Form 36 (SF36)'}, {'measure': 'Anxiety and depression', 'timeFrame': '6 months', 'description': 'Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'EuroQOL 5D', 'timeFrame': '6 months', 'description': 'Quality of life (EQ5D)'}, {'measure': 'Service use/health economics', 'timeFrame': '6 months', 'description': 'Study specific service use and health economics questionnaire'}, {'measure': 'Mortality rates', 'timeFrame': '6 months', 'description': 'Mortality rates collected by clinicians'}], 'secondaryOutcomes': [{'measure': 'Patient experience', 'timeFrame': '26 months', 'description': 'Interviews will be conducted with patients to explore their experiences in more detail.'}, {'measure': 'Carer quality of life', 'timeFrame': '6 months', 'description': 'Carer Quality of life- cancer questionnaire'}, {'measure': 'Caregiver burden', 'timeFrame': '6 months', 'description': 'Zarit Caregiver Burden'}, {'measure': 'Caregiver anxiety and depression', 'timeFrame': '6 months', 'description': 'Hospital Anxiety and Depression Scale (HADS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non small cell lung cancer', 'Stage III N2', 'Quality of life', 'Multi-modality treatment'], 'conditions': ['Lung Neoplasms', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '34266853', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n1. surgery PLUS chemo radiotherapy or chemotherapy\n2. 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.', 'detailedDescription': '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:\n\n1. surgery PLUS chemo radiotherapy or chemotherapy\n2. 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:\n\n * Symptoms\n * Side effects\n * Emotional well-being\n * Day to day activities\n\nOther 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stage III N2 non small cell lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with potentially resectable T1-4 N2 M0 NSCLC who have received an multi disciplinary team recommendation for multi-modality treatment\n* 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\n* Patient over the age of 18 years\n\nCarer criteria:\n\n* Carers of patients who have consented to take part in the randomised controlled trial\n* Over the age of 18 years\n\nExclusion Criteria:\n\n* Patients unable to provide informed consent\n* Patients who are not able to read and understand English'}, 'identificationModule': {'nctId': 'NCT04540757', 'acronym': 'PIONEER', 'briefTitle': 'Impact on Quality of Life From Multi-modality Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Christie NHS Foundation Trust'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'CFTSp176'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery', 'description': 'Surgery and systemic anti-cancer therapy (with or without radiotherapy) given in any order', 'interventionNames': ['Procedure: Surgery']}, {'label': 'No surgery', 'description': 'Radiotherapy and systemic anti-cancer treatment given in any order (with or without adjuvant immunotherapy if indicated).', 'interventionNames': ['Procedure: No surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Participants will be randomised to receive surgery as part of multi-modality treatment', 'armGroupLabels': ['Surgery']}, {'name': 'No surgery', 'type': 'PROCEDURE', 'description': 'Participants will be randomised to receive no surgery as part of multi-modality treatment', 'armGroupLabels': ['No surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M68HD', 'city': 'Salford', 'state': 'Greater Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Seamus Grundy, MD', 'role': 'CONTACT', 'email': 'seamus.grundy@srft@nhs.uk'}], 'facility': 'Salford Royal NHS Foundation Trust', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'M139WL', 'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Matthew Evison, MD', 'role': 'CONTACT', 'email': 'm.evison@nhs.net'}], 'facility': 'Manchester University Foundation Trust- Wythenshawe', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Sally Taylor, PhD', 'role': 'CONTACT', 'email': 'sally.taylor38@nhs.net', 'phone': '01619182446'}, {'name': 'Janelle Yorke, Prof', 'role': 'CONTACT', 'email': 'janelle.yorke@nhs.net'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Manchester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}