Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT00823667
Status:
COMPLETED
Last Update Posted:
2014-09-19
First Post:
2009-01-14
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 I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer That Can 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': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-18', 'studyFirstSubmitDate': '2009-01-14', 'studyFirstSubmitQcDate': '2009-01-14', 'lastUpdatePostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall quality of life and psychological distress', 'timeFrame': '1 year after study enrollment'}, {'measure': 'Symptom control', 'timeFrame': '1 year 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': '1 year after study enrollment'}, {'measure': 'Resource use as measured by chart audits', 'timeFrame': '1 year 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 12', 'timeFrame': 'Week 12 after study enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage I non-small cell lung cancer', 'stage II non-small cell lung cancer', 'stage IIIA non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '27794406', 'type': 'DERIVED', 'citation': 'Kim JY, Sun V, Raz DJ, Williams AC, Fujinami R, Reckamp K, Koczywas M, Cristea M, Hurria A, Ferrell B. The impact of lung cancer surgery on quality of life trajectories in patients and family caregivers. Lung Cancer. 2016 Nov;101:35-39. doi: 10.1016/j.lungcan.2016.08.011. Epub 2016 Aug 30.'}]}, '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 I, stage II, or stage IIIA non-small cell lung cancer that can 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 resectable stage I-IIIA non-small cell lung cancer.\n* To compare symptom control in these patients.\n* To compare geriatric assessment outcomes, as measured by OARS (Older Americans Resources and Services) Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS (Medical Outcomes Study)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 assigned to 1 of 2 groups.\n\n* Group I (standard care): Patients receive standard care. Patients complete questionnaires at baseline and at 6, 12, 24, 36, and 52 weeks to evaluate quality of life (QOL), symptoms, psychological distress, and geriatric assessments. A medical chart review is performed at 52 weeks to assess the progression of treatment, episodes of care, and re-admissions.\n* Group II (palliative care intervention): Patients receive an individualized interdisciplinary palliative care intervention combining patient-centered teaching principles and concepts that are learner-centered (builds on the strengths, interests, and needs of the learner), knowledge-centered (teacher is proficient in the content being taught), assessment-centered (learners are given an opportunity to test their understanding and receive feedback), and community-centered (opportunities are available for continued learning and support). Patients undergo 4 teaching sessions (based on the patient-centered teaching principles and concepts) that focus on physical, psychological, social, and spiritual well-being, respectively, once a week in weeks 3-6. Patients then receive 4 follow-up phone calls in weeks 9-21 to clarify questions or review concerns from the teaching sessions and to coordinate follow-up resources as needed. Patients also complete questionnaires as in group I.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stage I-IIIA resectable NSCLC - Undergoing either lobectomy, pneumonectomy, segmentectomy, or wedge resection\n* Living within a 50 mile radius of the City of Hope\n* No previous cancer within the past 5 years\n\nExclusion Criteria:\n\n* Diagnosis of stage II-III NSCLC that are not resectable based on clinical and individual characteristics (co-morbidities, extent of disease, bulky mediastinal lymph nodes \\[N2\\], etc.)\n* NSCLC patients receiving radiofrequency ablation'}, 'identificationModule': {'nctId': 'NCT00823667', 'briefTitle': 'Effects of Palliative Care on Quality of Life and Symptom Control in Patients With Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer That Can Be Removed by Surgery', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Palliative Care for Quality of Life and Symptom Concerns in Early Stage Lung Cancer', 'orgStudyIdInfo': {'id': '08034'}, '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-08034'}, {'id': 'CDR0000631255', 'type': 'REGISTRY', 'domain': 'NCI PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 1 Usual care', 'interventionNames': ['Other: medical chart review', 'Other: questionnaire administration', 'Procedure: end-of-life treatment/management', 'Procedure: psychosocial assessment and care', 'Procedure: quality-of-life assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2 Intervention', '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']}], 'interventions': [{'name': 'educational intervention', 'type': 'OTHER', 'description': 'Palliative care intervention at weeks 3,4,5 and 6 post study enrollment', 'armGroupLabels': ['Phase 2 Intervention']}, {'name': 'medical chart review', 'type': 'OTHER', 'description': 'Occurs at 1 year post study enrollment', 'armGroupLabels': ['Phase 1 Usual care', 'Phase 2 Intervention']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment', 'armGroupLabels': ['Phase 1 Usual care', 'Phase 2 Intervention']}, {'name': 'end-of-life treatment/management', 'type': 'PROCEDURE', 'description': 'Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment', 'armGroupLabels': ['Phase 1 Usual care', 'Phase 2 Intervention']}, {'name': 'psychosocial assessment and care', 'type': 'PROCEDURE', 'description': 'Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment', 'armGroupLabels': ['Phase 1 Usual care', 'Phase 2 Intervention']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'description': 'Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment', 'armGroupLabels': ['Phase 1 Usual care', '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'}}}}