Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT00823732
Status:
COMPLETED
Last Update Posted:
2015-11-06
First Post:
2009-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Palliative Care on Quality of Life and Symptom Control in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
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': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-04', 'studyFirstSubmitDate': '2009-01-15', 'studyFirstSubmitQcDate': '2009-01-15', 'lastUpdatePostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall quality of life and psychological distress', 'timeFrame': '6 months after study enrollment'}, {'measure': 'Symptom control', 'timeFrame': '6 months after study enrollment'}, {'measure': 'Geriatric assessment outcomes as measured by OARS Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale', 'timeFrame': '6 months after study enrollment'}, {'measure': 'Resource use as measured by chart audits', 'timeFrame': '6 months after study enrollment'}, {'measure': 'Identification of subgroups of patients who benefit most from the palliative care intervention in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 24', 'timeFrame': 'Week 24 after study enrollment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer', 'recurrent non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Palliative care may be more effective than standard care in improving quality of life and symptoms in patients with lung cancer.\n\nPURPOSE: This clinical trial is studying the effects of palliative care on quality of life and symptom control in patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery.', 'detailedDescription': 'OBJECTIVES:\n\n* To compare the effects of palliative care intervention (PCI) vs standard care on overall quality of life and psychological distress in patients with unresectable stage IIIB or IV non-small cell lung cancer.\n* To compare symptom control in these patients.\n* To compare geriatric assessment outcomes, as measured by OARS Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale, in these patients.\n* To compare the effects of the PCI vs standard care on resource use.\n* To identify subgroups of patients who benefit most from the PCI in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 12.\n\nOUTLINE: Patients are assigned to 1 of 2 groups.\n\nGroup I (usual care): Patients receive standard care.\n\nGroup II (palliative care intervention): Patients receive an individualized interdisciplinary palliative care intervention comprising sessions, focused on physical, psychological, social, and spiritual well-being, once weekly in weeks 3-6. Patients then receive 4 follow-up phone calls in weeks 9, 13, 17, and 21.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria:\n\n* Diagnosis of stage IIIb-IV unresectable NSCLC\n* Undergoing treatment with chemotherapy, radiation, or combined modalities\n* Living within a 50 mile radius of the City of Hope\n* No previous cancer within the past 5 years'}, 'identificationModule': {'nctId': 'NCT00823732', 'briefTitle': 'Effects of Palliative Care on Quality of Life and Symptom Control in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Palliative Care for Quality of Life and Symptom Concerns in Late Stage Lung Cancer', 'orgStudyIdInfo': {'id': '08035'}, 'secondaryIdInfos': [{'id': 'P01CA136396', 'link': 'https://reporter.nih.gov/quickSearch/P01CA136396', 'type': 'NIH'}, {'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}, {'id': 'CHNMC-08035'}, {'id': 'CDR0000631258', 'type': 'REGISTRY', 'domain': 'NCI PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2 Intervention', 'description': 'GROUP II (palliative care intervention): Patients receive an individualized interdisciplinary palliative care intervention comprising learner-centered, knowledge-centered, assessment-centered, and community-centered concepts. Patients undergo 4 teaching sessions, focused on physical, psychological, social, and spiritual well-being, once weekly in weeks 3-6. Patients then receive 4 follow-up phone calls in weeks 9, 13, 17, and 21.', 'interventionNames': ['Other: educational intervention', 'Other: medical chart review', 'Other: questionnaire administration', 'Procedure: end-of-life treatment/management', 'Procedure: psychosocial assessment and care', 'Procedure: quality-of-life assessment', 'Procedure: management of therapy complications', 'Procedure: assessment of therapy complications']}, {'type': 'NO_INTERVENTION', 'label': 'Phase I Usual Care', 'description': 'GROUP I (usual care): Patients receive standard care.'}], 'interventions': [{'name': 'educational intervention', 'type': 'OTHER', 'description': 'Undergo individualized interdisciplinary palliative care intervention', 'armGroupLabels': ['Phase 2 Intervention']}, {'name': 'medical chart review', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Phase 2 Intervention']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Phase 2 Intervention']}, {'name': 'end-of-life treatment/management', 'type': 'PROCEDURE', 'description': 'Undergo end-of-life treatment/management', 'armGroupLabels': ['Phase 2 Intervention']}, {'name': 'psychosocial assessment and care', 'type': 'PROCEDURE', 'description': 'Undergo psychosocial assessment and care', 'armGroupLabels': ['Phase 2 Intervention']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'description': 'Ancillary studies', 'armGroupLabels': ['Phase 2 Intervention']}, {'name': 'management of therapy complications', 'type': 'PROCEDURE', 'otherNames': ['complications of therapy, management of'], 'description': 'Undergo management of therapy complications', 'armGroupLabels': ['Phase 2 Intervention']}, {'name': 'assessment of therapy complications', 'type': 'PROCEDURE', 'description': 'Undergo assessment of therapy complications', 'armGroupLabels': ['Phase 2 Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Betty Ferrell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}