Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-29 @ 6:45 PM
Study NCT ID:
NCT07039292
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Alternatives for Reducing Harm Using E-cigarettes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 208}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete switching', 'timeFrame': '6 months', 'description': 'The percentage of participants who are abstinent from combustible cigarettes at the 6-month follow up'}], 'secondaryOutcomes': [{'measure': 'Implementation', 'timeFrame': '12 weeks', 'description': 'Percentage of people who smoke who engage in the intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking', 'E-Cig Use', 'Oncology']}, 'descriptionModule': {'briefSummary': 'For patients in cancer care, quitting smoking is critical, but a significant portion of patients in cancer care refuse all components of tobacco treatment, even when offered free of charge. The proposed clinical trial will assess one harm reduction intervention, switching completely from cigarettes to e-cigarettes, among oncology outpatients who smoke and refuse traditional tobacco treatment. This study is a type 1 hybrid effectiveness-implementation trial among oncology outpatients at an NCI-designated cancer center who smoke and refuse all components of tobacco treatment (N=208).', 'detailedDescription': "In the proposed study, we will conduct a type 1 hybrid effectiveness-implementation trial (N=208) to directly compare rates of switching to e-cigarettes to standard care, and advance understanding of key barriers and facilitators of implementation processes. Outpatients at HCC clinics who have opted out of traditional tobacco treatment will be randomly assigned to either 1) an e-cigarette switching approach (Switch), or 2) standard of care (SC; provision of additional tobacco treatment resources). We will compare rates of switching between the two groups, and conduct a mixed methods evaluation of implementation processes for the e-cigarette switching approach. To further evaluate the impact of harm reduction in this population, we will also collect exploratory data on the impact of switching to e-cigarettes on the biological effects of cancer risk (i.e., inflammation and DNA damage) and subjective effects of product use on health-related quality of life.\n\nPotential subjects will be recruited and screened for inclusion and exclusion criteria from MUSC's telehealth TTP. Once we have determined that someone meets our eligibility criteria, we will invite them to begin the consent process. Participants who consent to participation and are randomized will complete baseline assessments, a baseline breath CO, and a blood draw for baseline biomarker assessment. Participants in the Switch group will be provided with a 13-week supply of e-cigarettes and choose a switch date.\n\nParticipants will be asked to complete Assessments remotely via REDCap survey on the Target Switch Day (Week 0 Assessment), and every 2 weeks through the end of product provision (Week 12). An additional assessment will be completed at the Week 24 follow-up. Participants will complete a blood draw at Baseline, Week 12, and Week 24. Participants will complete a remote submission of breath carbon monoxide at baseline, Week 0 (Switch Date), Week 6, Week 12, and Week 24.\n\nWe will conduct semi-structured interviews with \\~20-25 participants from Switch after they complete the Week 24 follow-up to gain in-depth understanding of intervention experiences. We will also interview the primary providers from MUSC TTP who conducted the telehealth counseling component as well as other key clinic stakeholders. The providers will be interviewed on intervention acceptability including their perceptions of e-cigarettes as harm reduction tools, reach, fit within the clinic environment, resources to support and sustain the intervention in practice, and implementation barriers and facilitators."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 21+,\n* identified as smoking in their medical record and self-report of current smoking within the past 30 days\n* refused traditional treatment options through the opt-out HCC Tobacco Treatment Program\n* English speaking;\n\nExclusion Criteria:\n\n* currently taking part in any TTP or using cessation medication (i.e., taking NRT or other cessation medications, enrolled in the Quitline, or in another study),\n* use of e-cigarettes in the past 30 days,\n* currently imprisoned,\n* pregnant women.'}, 'identificationModule': {'nctId': 'NCT07039292', 'acronym': 'CARE', 'briefTitle': 'Clinical Alternatives for Reducing Harm Using E-cigarettes', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'A Novel Harm Reduction Approach for Oncology Outpatients Who Smoke and Refuse Traditional Tobacco Treatment', 'orgStudyIdInfo': {'id': 'Pro00138162'}, 'secondaryIdInfos': [{'id': '1R01CA293735-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA293735-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Harm Reduction (E-cigarette switching)', 'description': 'Participants will be assigned to receive an e-cigarette and try to switch completely from smoking to using the e-cigarette', 'interventionNames': ['Behavioral: Harm Reduction (E-cigarette switching)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Participants will be assigned to receive tobacco treatment referrals and the opportunity to re-enroll in the Tobacco Treatment Program', 'interventionNames': ['Behavioral: Standard of Care']}], 'interventions': [{'name': 'Harm Reduction (E-cigarette switching)', 'type': 'BEHAVIORAL', 'description': 'Participants will be assigned to receive an e-cigarette and try to switch completely from smoking to using the e-cigarette', 'armGroupLabels': ['Harm Reduction (E-cigarette switching)']}, {'name': 'Standard of Care', 'type': 'BEHAVIORAL', 'description': 'Participants will be assigned to receive tobacco treatment referrals and the opportunity to re-enroll in the Tobacco Treatment Program', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Paris Bedford', 'role': 'CONTACT', 'email': 'bedfordp@musc.edu', 'phone': '854-200-7314'}, {'name': 'Rachel Christian', 'role': 'CONTACT', 'email': 'chrisrac@musc.edu'}], 'overallOfficials': [{'name': 'Alana Rojewski', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}, {'name': 'Tracy Smith', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor-Faculty', 'investigatorFullName': 'Alana Rojewski', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}