Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05362318
Status:
COMPLETED
Last Update Posted:
2025-10-20
First Post:
2022-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Project HEALS (Helping and Empowering pAtients for Living a Life Smoke-free
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants who meet inclusion criteria', 'timeFrame': 'Baseline', 'description': 'Percentage of participants who meet inclusion criteria'}, {'measure': 'Percentage of participants who agree to participate in the study', 'timeFrame': 'Baseline', 'description': 'Percentage of participants who agree to participate in the study'}, {'measure': 'Percentage of participants completing baseline assessment', 'timeFrame': 'Baseline', 'description': 'Percentage of participants completing baseline assessment'}, {'measure': 'Percentage of participants completing the 3 month follow-up assessments', 'timeFrame': 'at 3 months', 'description': 'Percentage of participants completing the 3 month follow-up assessments'}, {'measure': 'Percentage of participants completing the 6 month follow-up assessments', 'timeFrame': 'at 6 months', 'description': 'Percentage of participants completing the 6 month follow-up assessments'}, {'measure': 'Treatment satisfaction - Acceptability', 'timeFrame': 'at 6 months', 'description': 'Mean scores of the Client Satisfaction Questionnaire (SCQ-8) will be used for this measure. The CSQ-8 comprises 8 items for the assessment of treatment satisfaction using a scale from 8 to 32, with higher scores indicating greater satisfaction.'}, {'measure': 'Completion rate of MAPS calls for UC+MAPS+RP participants - Demand', 'timeFrame': 'at 6 months', 'description': 'Percentage of MAPS calls completed for UC+MAPS+RP participants'}, {'measure': 'Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand', 'timeFrame': 'at 3 months', 'description': 'Percentage of UC+MAPS+RP participants who viewed the web based video'}, {'measure': 'Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand', 'timeFrame': 'at 6 months', 'description': 'Percentage of UC+MAPS+RP participants who viewed the web based video'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking', 'Tobacco Use', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to pilot test a multi-modal smoking cessation and relapse prevention intervention with the lung cancer patient population and to obtain preliminary data on its feasibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Smoked at least 100 cigarettes in lifetime\n* Current smoking (defined as self-report of any smoking, even a puff, in the past 30 days)\n* Diagnosis of lung cancer\n* Able to read and write English\n* Not currently enrolled in a smoking cessation program\n* Has a working telephone\n* Has a valid home address\n\nExclusion Criteria:\n\n* Current use of tobacco cessation medications\n* Another household member enrolled in this study\n* Contraindication of nicotine patch, unless under the supervision of a physician as advised by project staff\n* Moffitt clinical trial participant at time of enrollment'}, 'identificationModule': {'nctId': 'NCT05362318', 'briefTitle': 'Project HEALS (Helping and Empowering pAtients for Living a Life Smoke-free', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Motivating Smoking Cessation and Relapse Prevention Among Lung Cancer Patients: Helping and Empowering pAtients for Living a Life Smoke-free (Project HEALS)', 'orgStudyIdInfo': {'id': 'MCC-21108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1: Usual Care', 'description': 'Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges).', 'interventionNames': ['Drug: Nicotine patch and lozenges', 'Behavioral: Florida Tobacco Quitline']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention', 'description': 'Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges), 6 telephone counseling sessions over 6 months, and access to a web based video.', 'interventionNames': ['Drug: Nicotine patch and lozenges', 'Behavioral: Telephone counseling sessions', 'Behavioral: Access to a web-based video', 'Behavioral: Florida Tobacco Quitline']}], 'interventions': [{'name': 'Nicotine patch and lozenges', 'type': 'DRUG', 'description': "Participants will receive nicotine patch and lozenges. The regimen will be based on the participant's self-reported smoking rate. At the time of enrollment, a research staff member will determine the proper dose. Participants who smoke \\>10 cigarettes/day will receive 8 weeks of 21 mg. patches, 2 weeks of 14 mg. patches, 2 weeks of 7 mg. patches, and 12 weeks of 2 mg. lozenges. Those who smoke \\<10 cigarettes/day will receive 8 weeks of 14 mg. patches, 4 weeks of 7 mg patches, and 12 weeks of 2 mg. lozenges", 'armGroupLabels': ['Group 1: Usual Care', 'Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention']}, {'name': 'Telephone counseling sessions', 'type': 'BEHAVIORAL', 'description': 'Participants will be offered 6 Motivation and Problem Solving (MAPS)-based counseling sessions by phone over a 6-month period.', 'armGroupLabels': ['Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention']}, {'name': 'Access to a web-based video', 'type': 'BEHAVIORAL', 'description': 'Participants will be given web-based access to the relapse prevention video "Surviving Smokefree".', 'armGroupLabels': ['Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention']}, {'name': 'Florida Tobacco Quitline', 'type': 'BEHAVIORAL', 'description': 'Participants will receive an offer of enrollment to the Florida Tobacco Quitline which enables participant to speak with a Quit Coach who will assess nicotine addiction and help create a quit plan.', 'armGroupLabels': ['Group 1: Usual Care', 'Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33617', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Vani N Simmons, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}, {'name': 'Jennifer I Vidrine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}