Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-28 @ 7:39 AM
Study NCT ID:
NCT01351532
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2011-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-30', 'studyFirstSubmitDate': '2011-05-09', 'studyFirstSubmitQcDate': '2011-05-10', 'lastUpdatePostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking cessation', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Oral Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to apply this smoking cessation program on oral cancer patients, and to analyze the effectiveness of it.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of oral cancer\n* current smoker'}, 'identificationModule': {'nctId': 'NCT01351532', 'briefTitle': 'Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Behavior Change on Oral Cancer Patients After a Localized Behavior Change Model Intervention', 'orgStudyIdInfo': {'id': 'DMR100-IRB-063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling, smoking cessation drug', 'interventionNames': ['Behavioral: smoking cessation program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lifestyle counseling', 'interventionNames': ['Behavioral: Lifestyle counseling']}], 'interventions': [{'name': 'smoking cessation program', 'type': 'BEHAVIORAL', 'description': 'cross-theoretical model integrating smoking cessation counseling, smoking cessation drug utilization, physician interview and telephone counseling persuasion,', 'armGroupLabels': ['Lifestyle counseling, smoking cessation drug']}, {'name': 'Lifestyle counseling', 'type': 'BEHAVIORAL', 'description': 'ross-theoretical model integrating smoking cessation counseling,physician interview and telephone counseling persuasion', 'armGroupLabels': ['Lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404', 'city': 'Taichung', 'state': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}