Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-04 @ 10:18 PM
Study NCT ID:
NCT03669120
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2018-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2018-09-11', 'studyFirstSubmitQcDate': '2018-09-11', 'lastUpdatePostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Point prevalence abstinence', 'timeFrame': 'Up to 6 months', 'description': 'Seven day smoking abstinence along with negative saliva cotinine will be the primary definition of smoking abstinence for this study. Important covariates that will be used to adjust for potential baseline differences include level of education, biological sex, marital status, gender identity, race, working status, income, years smoking, smoking initiation, use of other tobacco products, and living with other household members who smoke.'}, {'measure': 'Salivary cotinine assessed by NicAlert test', 'timeFrame': 'Up to 6 months', 'description': 'Important covariates that will be used to adjust for potential baseline differences include level of education, biological sex, marital status, gender identity, race, working status, income, years smoking, smoking initiation, use of other tobacco products, and living with other household members who smoke.'}], 'primaryOutcomes': [{'measure': 'Computing recruitment rate', 'timeFrame': 'At baseline', 'description': 'Will be summarized using descriptive statistics such as the mean, standard deviation, median, interquartile range, and frequency where appropriate. Confidence intervals of 90% for the participating rates at baseline and retention rates at 3- and 6- follow-up will be provided.'}, {'measure': 'Retention rates', 'timeFrame': 'At 3 and 6 months', 'description': 'Will be summarized using descriptive statistics such as the mean, standard deviation, median, interquartile range, and frequency where appropriate. Confidence intervals of 90% for the participating rates at baseline and retention rates at 3- and 6- follow-up will be provided.'}], 'secondaryOutcomes': [{'measure': 'Levels of helpfulness', 'timeFrame': 'Up to 6 months', 'description': 'Will be measured by asking: "Were the text messages helpful in your attempt to quit smoking cigarettes?" (Likert scale from 0= Not at all helpful to 4=Very helpful). Will use t-test to compare between arms.'}, {'measure': 'Appropriateness', 'timeFrame': 'Up to 6 months', 'description': 'Will be measured by asking: "Regarding the number of text messages received per day, did you think that there were:" (Likert scale from 0=Too many to 2=Not enough). Will use t-test to compare between arms.'}, {'measure': 'Perceived difficulty', 'timeFrame': 'Up to 6 months', 'description': 'Will be measured by asking: "How easy was it to view the text messages?" (Likert scale from 0=Not at all easy to 4=Very easy) "How easy was it to respond to the text messages?" (Likert scale from 0=Not at all easy to 4=Very easy). Will use t-test to compare between arms.'}]}, '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 tailored smoking cessation intervention works in promoting sexual and gender minority smokers to quit smoking. A program that is specifically designed for the lesbian, gay, bisexual, and transgender community may affect these participants differently than a traditional approach.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To test the feasibility of two different approaches for smoking cessation (print materials developed for smoking cessation among the mainstream population versus \\[vs.\\] an individualized text based approach) among 60 lesbian, gay, bisexual, and transgender (LGBT) smokers.\n\nSECONDARY OBJECTIVES:\n\nI. To assess the levels of helpfulness, appropriateness, and perceived difficulty of the above mentioned cessation approaches among 60 LGBT smokers.\n\nEXPLORATORY OBJECTIVES:\n\nI. To test the smoking abstinence rates of two different individualized intensive cessation approaches (mainstream vs. individually-tailored) among 60 LGBT smokers.\n\nOUTLINE: Participants are randomized to 1 of 2 arms.\n\nARM I: Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of nicotine replacement therapy (NRT) in the form of nicotine patches, and intensive print materials to promote smoking cessation.\n\nARM II: Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months.\n\nAfter completion of study, participants are followed up at 3 and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female owning a cell phone with a reachable contact number\n* Self-identified as LGBT individual, regardless human immunodeficiency virus (HIV) serologic status\n* Smoked at least 100 cigarettes in lifetime\n* Currently smoking at least 5 cigarettes a day, on average\n* Willing to set a quit smoking date within a week of the enrollment\n* English speaking\n\nExclusion Criteria:\n\n* Expired carbon monoxide (CO) levels below 7 ppm\n* Positive history of a medical condition that precludes use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility)\n* Current use of NRT or other smoking cessation medications (e.g., varenicline or bupropion)\n* Pregnant or nursing\n* Enrolled in another smoking cessation program\n* Partner enrolled on current study'}, 'identificationModule': {'nctId': 'NCT03669120', 'briefTitle': 'Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Tailored or Non-Tailored Smoking Cessation Intervention for Sexual and Gender Minorities', 'orgStudyIdInfo': {'id': '2016-0564'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01821', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2016-0564', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'P30CA016672', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016672', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (mainstream instructional care)', 'description': 'Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of NRT in the form of nicotine patches, and intensive print materials to promote smoking cessation.', 'interventionNames': ['Other: Informational Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (tailored intensive care)', 'description': 'Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months.', 'interventionNames': ['Other: Informational Intervention', 'Behavioral: Telephone-Based Intervention']}], 'interventions': [{'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'Receive advice to quit smoking and materials to promote smoking cessation', 'armGroupLabels': ['Arm I (mainstream instructional care)', 'Arm II (tailored intensive care)']}, {'name': 'Telephone-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'Receive individualized text based messages', 'armGroupLabels': ['Arm II (tailored intensive care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Irene Tami-Maury', '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'}}}}