Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-26 @ 6:56 PM
Study NCT ID:
NCT04194918
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2019-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flexiquit+: Web Program to Promote Smoking Cessation in Sexual and Gender Minority Young Adult Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003143', 'term': 'Communication Devices for People with Disabilities'}], 'ancestors': [{'id': 'D012656', 'term': 'Self-Help Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-07', 'size': 696748, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-07-09T15:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2019-12-09', 'studyFirstSubmitQcDate': '2019-12-10', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment utilization', 'timeFrame': 'Enrollment up to 2 months', 'description': 'Will be determined by the server-recorded number of logins and the number of sessions completed. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Tables with N (%) or mean (standard deviation) by treatment arm will be provided.'}, {'measure': 'Treatment satisfaction: survey', 'timeFrame': 'Enrollment up to 2 months', 'description': 'Will be determined using 12 items on the 2-month outcome survey. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Categorical ratings for treatment satisfaction questions will be dichotomized as "somewhat", "mostly", or "very" useful versus (vs.) lower ratings. Tables with N (%) or mean (standard deviation) by treatment arm will be provided.'}], 'secondaryOutcomes': [{'measure': 'Smoking cessation rate', 'timeFrame': 'At 2 months post-enrollment', 'description': 'Will be assessed using the self-reported 7-day point prevalence abstinence at 2-month follow-up survey, biochemically confirmed with saliva cotinine.'}, {'measure': 'Change in motivation to quit smoking', 'timeFrame': 'From baseline to 2-month follow-up', 'description': 'Will be assessed using the Contemplation Ladder.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': 'This phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a sexual and/or gender minority to quit or cut down on smoking. Flexiquit+ is an avatar-led, web-based intervention that can help smokers quit or cut back on how much they smoke cigarettes and/or vape, reducing their chances of developing tobacco-related health conditions.', 'detailedDescription': 'OUTLINE:\n\nIndividuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.\n\nParticipants are followed up with at 2 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must self-identify as a sexual and/or gender minority (i.e., a sexual orientation other than straight and/or gender that doesn't match sex assigned at birth)\n* Participants must currently reside in the United States and anticipate remaining in the United States for the duration of the study (2 months)\n* Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening\n* Participants must self-report having at least weekly internet access for the next two months\n* Participants must self-report being willing and able to stream video online for this study\n* Participants must self-report current use of a personal email account\n* Participants must self-report current use of text messaging\n* Participants must self-report that they are interested in participating in the study for themselves (versus \\[vs\\] someone else)\n* Participants must self-report that they are not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program\n* Participants must self-report that they have not participated in one of our prior smoking cessation studies, including the user-centered research conducted in the development of Flexiquit+\n* Participants must self-report that they are comfortable reading, writing, and speaking English\n* Participants must self-report that they understand and agree to the conditions of compensation\n* Participants must self-report that they are not currently incarcerated in a prison\n* Participants must be willing to use the Flexiquit+ program, complete the study assessments, and sign an online consent form"}, 'identificationModule': {'nctId': 'NCT04194918', 'acronym': 'EQQUAL', 'briefTitle': 'Flexiquit+: Web Program to Promote Smoking Cessation in Sexual and Gender Minority Young Adult Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'A Scalable E-Health Smoking Cessation Intervention for Sexual and Gender Minority Young Adults', 'orgStudyIdInfo': {'id': 'RG1004771'}, 'secondaryIdInfos': [{'id': 'NCI-2019-08031', 'type': 'REGISTRY', 'domain': 'NCI / CTRP'}, {'id': 'P30CA015704', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015704', 'type': 'NIH'}, {'id': '10396', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevention (Flexiquit+, text message, handout)', 'description': 'Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.', 'interventionNames': ['Behavioral: Computer-Assisted Smoking Cessation Intervention', 'Other: Text Message', 'Other: Handout', 'Other: Questionnaire Administration', 'Other: Quality-of-Life Assessment', 'Other: Survey Administration']}], 'interventions': [{'name': 'Computer-Assisted Smoking Cessation Intervention', 'type': 'BEHAVIORAL', 'description': 'Use the Flexiquit+ program', 'armGroupLabels': ['Prevention (Flexiquit+, text message, handout)']}, {'name': 'Text Message', 'type': 'OTHER', 'otherNames': ['SMS Text', 'SMS Text Message', 'Text'], 'description': 'Receive text messages', 'armGroupLabels': ['Prevention (Flexiquit+, text message, handout)']}, {'name': 'Handout', 'type': 'OTHER', 'description': 'Receive handouts via email', 'armGroupLabels': ['Prevention (Flexiquit+, text message, handout)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Prevention (Flexiquit+, text message, handout)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Prevention (Flexiquit+, text message, handout)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Prevention (Flexiquit+, text message, handout)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jaimee Heffner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'The Safeway Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}