Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-02-24 @ 11:06 AM
Study NCT ID:
NCT01993550
Status:
COMPLETED
Last Update Posted:
2016-03-10
First Post:
2013-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telephone Support Program for Lung Cancer Patients and Their Family Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-09', 'studyFirstSubmitDate': '2013-11-11', 'studyFirstSubmitQcDate': '2013-11-20', 'lastUpdatePostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient Health Questionnaire-8', 'timeFrame': 'baseline, 2 and 6 weeks post-intervention'}, {'measure': 'Change in Generalized Anxiety Disorder 7-item scale', 'timeFrame': 'baseline, 2 and 6 weeks post-intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lung cancer', 'family caregiving', 'behavioral intervention', 'counseling', 'symptom management'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '29366911', 'type': 'DERIVED', 'citation': 'Winger JG, Rand KL, Hanna N, Jalal SI, Einhorn LH, Birdas TJ, Ceppa DP, Kesler KA, Champion VL, Mosher CE. Coping Skills Practice and Symptom Change: A Secondary Analysis of a Pilot Telephone Symptom Management Intervention for Lung Cancer Patients and Their Family Caregivers. J Pain Symptom Manage. 2018 May;55(5):1341-1349.e4. doi: 10.1016/j.jpainsymman.2018.01.005. Epub 2018 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this project is to examine the physical and psychological health benefits of a novel, telephone-delivered symptom management intervention for advanced lung cancer patients and their family caregivers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of lung cancer\n* Must be able to speak and read English\n\nExclusion Criteria:\n\n* No working phone service\n* Does not have a family caregiver'}, 'identificationModule': {'nctId': 'NCT01993550', 'briefTitle': 'Telephone Support Program for Lung Cancer Patients and Their Family Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Telephone Symptom Management for Advanced Lung Cancer Patients and Caregivers', 'orgStudyIdInfo': {'id': '1K07CA168883-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K07CA168883-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1K07CA168883-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K07CA168883-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telephone counseling', 'description': 'Telephone counseling to enhance symptom management and reduce distress', 'interventionNames': ['Behavioral: Telephone counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education', 'description': 'Overview of resources for psychosocial support and health information', 'interventionNames': ['Behavioral: Education']}], 'interventions': [{'name': 'Telephone counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Telephone counseling']}, {'name': 'Education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Eskenazi Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Richard L. Roudebush VA Medical Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Catherine E. Mosher, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indiana University School of Medicine', 'class': 'OTHER'}, {'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}