Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-30 @ 6:54 AM
Study NCT ID:
NCT06786468
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2025-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life score (FACT-L Total Score)', 'timeFrame': '12 weeks after treatment', 'description': 'The patients were asked to assess their Health-related Quality Of Life (HRQoL) using FACT-L (Functional Assessment of Cancer Therapy - Lung) questionnaire. The score ranges from 0-136 with higher score indicating better HRQoL.'}], 'secondaryOutcomes': [{'measure': 'Change in quality of life (FACT-L Total Scores)', 'timeFrame': '12 and 24 weeks after treatment', 'description': 'The patients were asked to assess their Health-related Quality Of Life (HRQoL) using FACT-L (Functional Assessment of Cancer Therapy - Lung) questionnaire. The score ranges from 0-136 with higher score indicating better HRQoL. Change in FACT-L Total Scores defined as the difference between FACT-L Total Score at a specified time point minus baseline FACT-L Total Score.'}, {'measure': 'Change in mental health score (PHQ-9)', 'timeFrame': '12 and 24 weeks after treatment', 'description': 'The patients were asked to assess their depression levels using a Patient Health Questionnaire 9 (PHQ-9). The score ranges from 0-27 with 0 indicating no depression and 27 indicating severe depression.'}, {'measure': 'Change in pain score', 'timeFrame': '12 and 24 weeks after treatment', 'description': 'The patients were asked to assess their pain using a Numerical Rating Scale (NRS). The score ranges from 0-10 with 0 indicating no pain and 10 indicating worst pain imaginable.'}, {'measure': 'One-year survival rate', 'timeFrame': 'One year after treatment'}, {'measure': 'Two-year survival rate', 'timeFrame': 'Two years after treatment'}, {'measure': 'Proportion of patients who have advanced care plan', 'timeFrame': 'six months'}, {'measure': 'Change in utility score measured by EQ-5D-5L questionnaire', 'timeFrame': '12 and 24 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early palliative care', 'palliative care', 'lung cancer'], 'conditions': ['Lung Cancer - Non Small Cell', 'Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': 'Early palliative care has been shown to improve the survival of advanced lung cancer patients. However, most of the clinical studies were performed in the era when systemic treatment options for this disease were limited. Currently, many effective treatment options are available, including targeted therapy and immunotherapy. These novel agents improve the treatment outcomes while having less toxicity compared to conventional chemotherapy. Moreover, medical oncologists are now trained to provide palliative care for patients. This study was designed to demonstrate whether early palliative care provided by the palliative care specialist still improves the quality of life or survival of advanced lung cancer patients compared to standard care provided by the medical oncologist.', 'detailedDescription': 'Advanced non-small cell lung cancer patients initiating a systemic treatment will be randomized to the early palliative care arm (attending a palliative care clinic once a month during the first three months concurrently with oncology clinic appointment) or the standard care arm (attending oncology clinic only). The patients will be asked to complete the quality of life questionnaires (FACT-L, EQ-5D-5L), mental health questionnaire (PHQ-9), and pain assessment once a month for three months and at the sixth month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at least 18 years old\n* Pathologically confirmed advanced non-small cell lung cancer\n* Plan to receive systemic treatment for lung cancer within three weeks\n* ECOG performance status 0-2 with estimated life expectancy \\> 24 weeks\n* Having at least 4 scores according to Edmonton Symptom Assessment System (ESAS)\n* Able to complete the questionnaires\n\nExclusion Criteria:\n\n* Had received systemic treatment for advanced lung cancer before'}, 'identificationModule': {'nctId': 'NCT06786468', 'briefTitle': 'Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Randomized Controlled Trial of Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients', 'orgStudyIdInfo': {'id': '068/2567(IRB3)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early palliative care with standard care', 'description': 'The patients will attend palliative care clinic once a month during the first three months together with oncology clinic visits', 'interventionNames': ['Other: Early palliative care integration', 'Drug: Standard systemic treatment for advanced lung cancer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'The patients will attend oncology clinic as usual', 'interventionNames': ['Drug: Standard systemic treatment for advanced lung cancer']}], 'interventions': [{'name': 'Early palliative care integration', 'type': 'OTHER', 'description': 'The patients will attend palliative care clinic once a month during the first three months together with routine oncology clinic visits', 'armGroupLabels': ['Early palliative care with standard care']}, {'name': 'Standard systemic treatment for advanced lung cancer', 'type': 'DRUG', 'description': 'Standard systemic treatment for advanced lung cancer', 'armGroupLabels': ['Early palliative care with standard care', 'Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Lucksamon Thamlikitkul, MD, PhD', 'role': 'CONTACT', 'email': 'lucksamon.tha@mahidol.edu', 'phone': '+6624194489'}, {'name': 'Lucksamon Thamlikitkul, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Lucksamon Thamlikitkul, MD, PhD', 'role': 'CONTACT', 'email': 'lucksamon.tha@mahidol.edu', 'phone': '+6624194489'}], 'overallOfficials': [{'name': 'Lucksamon Thamlikitkul, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}