Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:54 PM
Study NCT ID:
NCT07447635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing an MBI for Smoking Cessation and Alcohol Use Among Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D004327', 'term': 'Drinking Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074602', 'term': 'Smoking Devices'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence', 'timeFrame': '6 months post treatment', 'description': 'Self-reported no combustible tobacco use in the past 7 days, verified with saliva cotinine \\<10 ng/mL.'}, {'measure': 'Percent Heavy Drinking Days (Past 4 Weeks)', 'timeFrame': '6 months post treatment', 'description': 'Percentage of days in the past 4 weeks meeting heavy drinking criteria (≥5 drinks for men; ≥4 drinks for women)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness-based intervention', 'Cancer survivors', 'Smoking cessation', 'Alcohol use'], 'conditions': ['Smoking Cessation', 'Alcohol Use']}, 'descriptionModule': {'briefSummary': 'This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. Investigators will evaluate implementation outcomes through structured stakeholder interviews across medical centers, cancer-focused organizations, and community-based programs in Florida, and will conduct a cost-assessment and an incremental cost-effectiveness analysis of the two conditions.', 'detailedDescription': 'The primary aim of this study is to test the efficacy of MBRP-SA compared with standard care among cancer survivors, explore potential moderators, mechanisms, and predictors of treatment effects, and evaluate implementation outcomes to guide future adoption of MBRP-SA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old\n* History of a cancer diagnosis at any point in lifetime\n* Smoked ≥1 cigarette/day in past month\n* At least one binge drinking episode in past month or exceeds weekly drinking limits\n* Motivated to quit smoking and modify alcohol use in next 30 days\n* Valid home address in Florida\n* English-speaking, reading, and writing ability\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Active psychotic disorder\n* History of severe alcohol withdrawal\n* Current use of tobacco cessation medication or other treatments to quit smoking\n* End-of-life or hospice care\n* Household member already enrolled'}, 'identificationModule': {'nctId': 'NCT07447635', 'briefTitle': 'Testing an MBI for Smoking Cessation and Alcohol Use Among Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Smoking Cessation and Alcohol Use Among Cancer Survivors: Investigating the Efficacy of a Mindfulness-Based Intervention', 'orgStudyIdInfo': {'id': 'MCC-23894'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)', 'description': 'Participants randomized to this condition will receive a mindfulness-based intervention delivered in a group format via Zoom.', 'interventionNames': ['Behavioral: Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)']}, {'type': 'EXPERIMENTAL', 'label': 'Quitline Support', 'description': 'Participants randomized to this condition will be connected to the Florida Tobacco Quitline for smoking cessation services, as well as receive community referrals for alcohol use treatment.', 'interventionNames': ['Behavioral: Quitline Support']}], 'interventions': [{'name': 'Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)', 'type': 'BEHAVIORAL', 'description': 'MBRP-SA is a nine-week, group-based mindfulness program designed to help cancer survivors quit smoking and reduce heavy alcohol use by targeting craving, stress, and habitual behavior patterns. Participants will also receive 10 weeks of nicotine replacement therapy.', 'armGroupLabels': ['Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)']}, {'name': 'Quitline Support', 'type': 'BEHAVIORAL', 'description': 'Participants will be connected to the Florida Tobacco Quitline, which provides standard evidence-based smoking cessation support, including phone-based counseling, web-based resources, and access to text-messaging programs. The Quitline also offers up to a four-week supply of nicotine replacement therapy (patches, gum, or lozenges). Participants will also receive referrals to various alcohol-related treatment options in the community.', 'armGroupLabels': ['Quitline Support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Christine Vinci, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vani Simmons, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Steve Sutton, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Margaret Byrne, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kea Turner, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katie Witkiewitz, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Skye Dougan, MPH', 'role': 'CONTACT', 'email': 'Skye.Dougan@moffitt.org', 'phone': '813-745-4376'}, {'name': 'Marilyn Horta, PhD', 'role': 'CONTACT', 'email': 'Marilyn.Horta@moffitt.org', 'phone': '813-745-3861'}], 'overallOfficials': [{'name': 'Christine Vinci, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida Biomedical Research Program - James & Esther King', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}