Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2025-12-26 @ 1:44 AM
Study NCT ID:
NCT00827333
Status:
COMPLETED
Last Update Posted:
2016-08-02
First Post:
2009-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell 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': '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': 372}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2009-01-21', 'studyFirstSubmitQcDate': '2009-01-21', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caregiver burden', 'timeFrame': '24 weeks post study enrollment'}, {'measure': 'Caregiver skills preparedness', 'timeFrame': '24 weeks post study enrollment'}, {'measure': 'Caregiver quality of life', 'timeFrame': '24 weeks post study enrollment'}, {'measure': 'Caregiver psychological distress', 'timeFrame': '24 weeks post study enrollment'}, {'measure': 'Caregiver self-care behavior', 'timeFrame': '24 weeks post study enrollment'}, {'measure': 'Resource use by caregiver', 'timeFrame': '24 weeks post study enrollment'}, {'measure': 'Identification of a subgroup of caregivers who benefit most from the family caregiver palliative care intervention in relation to sociodemographic characteristics and clinical/functional factors', 'timeFrame': '24 weeks post study enrollment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent non-small cell lung cancer', 'stage I non-small cell lung cancer', 'stage II non-small cell lung cancer', 'stage IIIA non-small cell lung cancer', 'stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Palliative care teaching sessions may be more effective than standard care in improving caregiver burden, caregiver skills preparedness, quality of life, and distress in family caregivers of patients with non-small cell lung cancer.\n\nPURPOSE: This clinical trial is studying the effects of palliative care teaching sessions in family caregivers of patients with non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nI. Test the effects of a family caregiver palliative care intervention (FCPCI) for informal caregivers of patients with early and late stage lung cancer on caregiver burden and caregiver skills preparedness as compared to a group of family caregivers (FC) in a usual care situation.\n\nII. Test the effects of a FCPCI for informal caregivers of patients with early and late stage lung cancer on FC in a usual care situation.\n\nIII. Describe early and late stage FC self care behavior, comparing the usual care and FCPCI groups.\n\nIV. Describe resource use by early and late stage FC comparing the usual care and FCPCI groups. V. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.\n\nV. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.\n\nOUTLINE: Family caregivers (FC) are assigned to 1 of 2 groups.\n\nGROUP I: FC complete questionnaires at baseline and at 7, 12, 18, and 24 weeks to assess caregiver burden, caregiver skills preparedness, quality of life, distress, self care, and resource use.\n\nGROUP II: FC undergo 4 individualized teaching sessions in weeks 7, 8, 10, and 12 that focus on caregiver burden; caregiver skills preparedness; management of patient psychological symptoms; management of FC distress; social and spiritual needs of the patient and FC; the continuing role of the FC in caring for the patient; and development of a personalized wellness plan. FC then receive 3 follow-up phone calls in weeks 16, 20, and 24 to review any questions regarding care; to assess symptom management, community resources, and support; and to review and support the wellness plan. FC also complete questionnaires as in group I.\n\nAfter completion of the educational intervention, a sample of FC undergo 1-hour educational interviews exploring their perspective and insights on their experience as a caregiver.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The primary family caregiver as identified by a patient with early or late stage non-small cell lung cancer (NSCLC) participating in Project 1 and 2\n* Patients having been accrued to project 1 or project 2'}, 'identificationModule': {'nctId': 'NCT00827333', 'briefTitle': 'Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Palliative Care for Quality of Life and Symptom Concerns in Family Caregivers of Lung Cancer Patients', 'orgStudyIdInfo': {'id': '08036'}, '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-08036'}, {'id': 'CDR0000631261', 'type': 'REGISTRY', 'domain': 'NCI PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Phase I-Usual Care'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2 - Intervention', 'interventionNames': ['Other: educational intervention', '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': 'Family Caregiver Palliative Care Intervention at weeks 7, 8, 10, and 12 post study enrollment', 'armGroupLabels': ['Phase 2 - Intervention']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment', 'armGroupLabels': ['Phase 2 - Intervention']}, {'name': 'end-of-life treatment/management', 'type': 'PROCEDURE', 'description': 'Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment', 'armGroupLabels': ['Phase 2 - Intervention']}, {'name': 'psychosocial assessment and care', 'type': 'PROCEDURE', 'description': 'Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment', 'armGroupLabels': ['Phase 2 - Intervention']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'description': 'Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment', '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'}}}}