Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-25 @ 8:48 PM
Study NCT ID:
NCT00941395
Status:
COMPLETED
Last Update Posted:
2018-11-21
First Post:
2009-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Smoking Cessation for University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-20', 'studyFirstSubmitDate': '2009-07-15', 'studyFirstSubmitQcDate': '2009-07-15', 'lastUpdatePostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ease of use and appeal of various features of the program', 'timeFrame': 'Up to 5 months'}, {'measure': 'The quality of the interactive multi-media presentations and their ability to generate interest in smoking cessation and prevention', 'timeFrame': 'Up to 5 months'}, {'measure': 'Behavior modification determined by EVOLVE Follow up Survey-Smoker', 'timeFrame': 'Up to 5 months'}, {'measure': 'Knowledge of modules in the program', 'timeFrame': 'Up to 5 months'}, {'measure': 'Feasibility defined as 90% of the student participants indicating that the intervention program is easy to use and can fit into their schedule', 'timeFrame': 'Up to 5 months', 'description': 'Associations between the dependent variables and smoking status will be evaluated with linear and logistic regression models with campus of origin and smoking status as independent predictors of these outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cigarette Smoker', 'Current Every Day Smoker']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This trial studies how well a new smoking cessation and prevention intervention works in enhancing smoking cessation for university students. The new intervention may be easier to use for students to quit smoke.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To establish the feasibility of a new smoking cessation and prevention intervention including two new modules addressing alcohol use and depression.\n\nII. Demonstrate the feasibility of a smoking prevention website.\n\nOUTLINE: Participants are assigned to 1 of 2 arms.\n\nARM I: Participants who currently smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2. Participants also complete 3 internet surveys over 20 minutes.\n\nARM II: Participants who currently do not smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2.\n\nAfter completion of study, participants are followed up at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CESSATION ARM: Student at University of Houston Central Campus or Texas A\\&M University\n* CESSATION ARM: Smoke 1 or more cigarettes a day\n* CESSATION ARM: Speak and read English\n* CESSATION ARM: Signed informed consent and an acknowledgement of participation requirements\n* CESSATION ARM: Be enrolled in at least one class at respective campus at baseline\n* CESSATION ARM: Provide current contact information\n* CESSATION ARM: Have access to the Internet\n* PREVENTION ARM: Student at University of Houston Central Campus or Texas A\\&M University\n* PREVENTION ARM: Speak and read English\n* PREVENTION ARM: Signed Informed Consent and an acknowledgement of participation requirements\n* PREVENTION ARM: Be enrolled in at least one class at respective campus at baseline\n* PREVENTION ARM: Provide current contact information\n* PREVENTION ARM: Have access to the Internet\n* PREVENTION ARM: Evidence of smoking susceptibility (as defined by the Smoking Susceptibility Scale)\n* CESSATION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study\n* PREVENTION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study\n\nExclusion Criteria:\n\n* CESSATION ARM: Evidence of major depressive disorder (as defined by PHQ-9 \\[Patient Health Questionnaire-9\\])\n* CESSATION ARM: Evidence of severe alcohol abuse (as defined by AUDIT \\[Alcohol Use Disorders Identification Test\\] measure)\n* PREVENTION ARM: Current tobacco use\n* PREVENTION ARM: Does not plan to continue as a student at their campus for at least one more year\n* CESSATION ARM: Does not plan to continue as a student at their campus for at least one more year\n* PREVENTION ARM: Evidence of major depressive disorder (as defined by PHQ-9 \\[Patient Health Questionnaire-9\\])\n* PREVENTION ARM: Evidence of severe alcohol abuse (as defined by AUDIT measure)\n* CESSATION ARM: Pregnancy'}, 'identificationModule': {'nctId': 'NCT00941395', 'briefTitle': 'Enhanced Smoking Cessation for University Students', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Enhanced Smoking Cessation for University Students', 'orgStudyIdInfo': {'id': '2009-0351'}, 'secondaryIdInfos': [{'id': 'NCI-2018-02552', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2009-0351', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'P30CA016672', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016672', 'type': 'NIH'}, {'id': 'R01CA069425', 'link': 'https://reporter.nih.gov/quickSearch/R01CA069425', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (smoker, survey)', 'description': 'Participants who currently smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2. Participants also complete 3 internet surveys over 20 minutes.', 'interventionNames': ['Other: Survey Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (non-smoker, survey)', 'description': 'Participants who currently do not smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2.', 'interventionNames': ['Other: Survey Administration']}], 'interventions': [{'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Complete surveys', 'armGroupLabels': ['Arm I (smoker, survey)', 'Arm II (non-smoker, survey)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77843', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas A&M', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Alexander Prokhorov', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}