Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT01248832
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2010-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smokers' Quitline for Asian Language Speakers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2010-11-24', 'studyFirstSubmitQcDate': '2010-11-24', 'lastUpdatePostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who are continuously abstinent from cigarettes', 'timeFrame': '7-months post enrollment', 'description': 'Continuous abstinence from cigarettes'}], 'secondaryOutcomes': [{'measure': 'Number of participants who are continuously abstinent from cigarettes', 'timeFrame': '4-months post enrollment', 'description': 'Continuous abstinence from cigarettes'}, {'measure': 'Rate of serious quit attempts', 'timeFrame': '4-months post enrollment', 'description': 'Quit Attempts'}, {'measure': '30-day point prevalence', 'timeFrame': '4-months post enrollment', 'description': '30-day point prevalence'}, {'measure': '30-day point prevalence', 'timeFrame': '7-months post enrollment', 'description': '30-day point prevalence'}, {'measure': 'Rate of serious quit attempts', 'timeFrame': '7-months post enrollment', 'description': 'Quit Attempts'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tobacco cessation', 'smoking cessation', 'telephone', 'self-help', 'smoking abstinence', 'tobacco use disorder', 'disparity'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '20299658', 'type': 'BACKGROUND', 'citation': "Zhu SH, Wong S, Stevens C, Nakashima D, Gamst A. Use of a smokers' quitline by Asian language speakers: results from 15 years of operation in California. Am J Public Health. 2010 May;100(5):846-52. doi: 10.2105/AJPH.2009.168385. Epub 2010 Mar 18."}]}, 'descriptionModule': {'briefSummary': "The study tested the effects of telephone counseling for smokers from three Asian language speaking groups: Chinese, Korean, and Vietnamese. The specific aims were to: 1) test the efficacy of a culturally appropriate counseling protocol for smokers calling the California Smokers' Helpline on the Chinese, Korean and Vietnamese lines, 2) examine whether intervention effects varied by cognitive and behavioral predictors of cessation success, 4) examine whether family involvement plays a role in quitting success, and 5) assess differences in counseling effect across the three ethnic groups.", 'detailedDescription': 'Asian Americans are among the least studied groups in smoking research, which has created a knowledge gap in understanding their behavior and in developing methods to help them quit. No efficacy data have been reported for telephone counseling of smokers who prefer to use Asian languages, although telephone intervention holds promise for these groups because of its convenience and its potential to reach large numbers of smokers. In this two-arm design subjects are stratified by language (Chinese, Korean, and Vietnamese) and randomized to telephone counseling (plus materials) or self-help materials only, which serves as the control. The study is significant in several ways. First, it provides timely information on a cessation approach for a traditionally under-served population (Asian language speakers). Second, effective telephone counseling can be widely applied because of the proliferation of quitlines with centralized services in recent years. Third, by targeting Asian language speakers this study addresses the issue of ethnic disparities, which has been identified by many (including the NCI Bypass Budget) as a research priority.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years old,\n* daily smoker,\n* ready to quit within one month,\n* first time caller,\n* valid phone number,\n* valid address,\n* California (CA) resident,\n* gave consent to participate in study and evaluation,\n* called the Chinese, Korean or Vietnamese line\n\nExclusion Criteria:\n\n* used other form of tobacco,\n* major medical or psychiatric complication (e.g. lung cancer, major depressive disorder, anti-psychotic medicine, recent stroke, impending surgery)'}, 'identificationModule': {'nctId': 'NCT01248832', 'briefTitle': "Smokers' Quitline for Asian Language Speakers", 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': "Smokers' Quitline for Asian Language Speakers", 'orgStudyIdInfo': {'id': '5R01CA104573-5'}, 'secondaryIdInfos': [{'id': 'R01CA104573', 'link': 'https://reporter.nih.gov/quickSearch/R01CA104573', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telephone Counseling', 'description': 'Telephone Counseling', 'interventionNames': ['Behavioral: Telephone Counseling', 'Behavioral: Self-Help Materials']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self-help Materials', 'description': 'Self-help Materials', 'interventionNames': ['Behavioral: Self-Help Materials']}], 'interventions': [{'name': 'Telephone Counseling', 'type': 'BEHAVIORAL', 'description': 'Counseling is conducted in Mandarin, Cantonese, Korean, or Vietnamese by counselors at the Helpline. The protocol used is similar to that proved efficacious. However, to make the counseling culturally appropriate for Asian language speakers, we: capitalizing on first contact, present the Helpline as a credible quit smoking program staffed by "experts", avoid the term "counseling" since it is associated with mental illness, and assume a more authoritative role and directive counseling style. Counseling is proactive (1st call is made by smoker, then subsequent calls are made by the counselor) to help reduce attrition. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) scheduled according to the probability of relapse.', 'armGroupLabels': ['Telephone Counseling']}, {'name': 'Self-Help Materials', 'type': 'BEHAVIORAL', 'description': 'All subjects (both in the telephone counseling group and the materials-only group) receive self-help materials in teh appropriate language. Materials were created in-house, are written in the appropriate language, and cover the essentials of the quitting process such as motivation, physiological and emotional responses to quitting, nicotine in the body, quitting aids, quitting strategies (including those that might be culturally specific such as acupuncture or herbs), setting a quit date, planning, relapse prevention, differentiating between slips and relapse, long-term maintenance, and developing the nonsmoker self-image.', 'armGroupLabels': ['Self-help Materials', 'Telephone Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Shu-Hong Zhu, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shu-Hong Zhu', 'investigatorAffiliation': 'University of California, San Diego'}}}}