Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT01123967
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2010-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Offering Proactive Tobacco Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2010-05-12', 'studyFirstSubmitQcDate': '2010-05-13', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Results in Abstinence Rates', 'timeFrame': '1 Year', 'description': 'Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level smoking abstinence rates among a diverse population of low income smokers.'}], 'secondaryOutcomes': [{'measure': 'Results in Treatment Utilization', 'timeFrame': '1 Year', 'description': 'Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level tobacco treatment utilization rates among a diverse population of low income smokers.'}, {'measure': 'Cost-Effectiveness of Program', 'timeFrame': '1 Year', 'description': 'Determine the cost-effectiveness of PRO+NRT+TC compared with UC.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nicotine replacement therapy', 'smoking cessation', 'tobacco dependent'], 'conditions': ['Tobacco Use Cessation']}, 'referencesModule': {'references': [{'pmid': '32614201', 'type': 'DERIVED', 'citation': 'Hammett PJ, Japuntich SJ, Sherman SE, Rogers ES, Danan ER, Noorbaloochi S, El-Shahawy O, Burgess DJ, Fu SS. Proactive tobacco treatment for veterans with posttraumatic stress disorder. Psychol Trauma. 2021 Jan;13(1):114-122. doi: 10.1037/tra0000613. Epub 2020 Jul 2.'}, {'pmid': '31363948', 'type': 'DERIVED', 'citation': 'Hammett PJ, Lando HA, Erickson DJ, Widome R, Taylor BC, Nelson D, Japuntich SJ, Fu SS. Proactive outreach tobacco treatment for socioeconomically disadvantaged smokers with serious mental illness. J Behav Med. 2020 Jun;43(3):493-502. doi: 10.1007/s10865-019-00083-8. Epub 2019 Jul 30.'}, {'pmid': '26931362', 'type': 'DERIVED', 'citation': 'Fu SS, van Ryn M, Nelson D, Burgess DJ, Thomas JL, Saul J, Clothier B, Nyman JA, Hammett P, Joseph AM. Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial. Thorax. 2016 May;71(5):446-53. doi: 10.1136/thoraxjnl-2015-207904. Epub 2016 Mar 1.'}, {'pmid': '24716466', 'type': 'DERIVED', 'citation': 'Fu SS, van Ryn M, Burgess DJ, Nelson D, Clothier B, Thomas JL, Nyman JA, Joseph AM. Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial. BMC Public Health. 2014 Apr 9;14:337. doi: 10.1186/1471-2458-14-337.'}]}, 'descriptionModule': {'briefSummary': 'This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Population impact is the product of treatment utilization (i.e., reach or exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize treatment).', 'detailedDescription': 'Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must complete the baseline survey\n* Current self-reported cigarette smoker\n* Has a valid home address\n* An adequate proficiency in English to complete study surveys and participate in telephone counseling.\n\nexclusion Criteria:\n\n* adult smokers not enrolled in the Minnesota Health Care Programs (MHCP).'}, 'identificationModule': {'nctId': 'NCT01123967', 'briefTitle': 'Offering Proactive Tobacco Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations', 'orgStudyIdInfo': {'id': '2009NTLS064'}, 'secondaryIdInfos': [{'id': '0909S72235', 'type': 'OTHER', 'domain': 'IRB, University of Minnesota'}, {'id': '1R01CA141527', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA141527', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRO+NRT+TC', 'description': 'Proactive outreach (mailed invitation letter followed by telephone outreach) combined with free nicotine replacement therapy (NRT) and telephone counseling (PRO+NRT+TC)to usual care (UC)', 'interventionNames': ['Other: proactive outreach (PRO)', 'Other: telephone counseling (TC)', 'Other: Nicotine replacement therapy (NRT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care (UC)', 'description': 'Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray', 'interventionNames': ['Other: Usual care (UC)']}], 'interventions': [{'name': 'proactive outreach (PRO)', 'type': 'OTHER', 'description': 'a mailed invitation letter followed by telephone outreach', 'armGroupLabels': ['PRO+NRT+TC']}, {'name': 'telephone counseling (TC)', 'type': 'OTHER', 'description': 'free telephone counseling', 'armGroupLabels': ['PRO+NRT+TC']}, {'name': 'Nicotine replacement therapy (NRT)', 'type': 'OTHER', 'description': 'free nicotine replacement therapy (NRT)', 'armGroupLabels': ['PRO+NRT+TC']}, {'name': 'Usual care (UC)', 'type': 'OTHER', 'description': 'nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)', 'armGroupLabels': ['Usual Care (UC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Steven Fu, M.D.', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Steven Fu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Veterans Administration Hospital'}, {'name': 'Anne Joseph, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}