Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT04200534
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'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': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-27', 'size': 637816, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-18T10:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 358}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smoking abstinence Questionnairre', 'timeFrame': 'Up to 12 weeks', 'description': 'Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates)'}, {'measure': 'Lung Cancer Screening 12 items version', 'timeFrame': 'Up to 12 weeks', 'description': 'Knowledge of lung cancer screening and benefits of smoking cessation'}], 'secondaryOutcomes': [{'measure': 'Number of patients who received smoking cessation counseling and shared decision making over the number of patients consented to participate in the study', 'timeFrame': 'Up to 12 weeks', 'description': 'Assessment of the reach of the intervention'}, {'measure': 'Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al).', 'timeFrame': 'Up to 12 weeks', 'description': 'Assessment of the feasibility of implementing the intervention'}, {'measure': 'Fidelity checklist (11 items)', 'timeFrame': 'Up to 12 weeks', 'description': 'Assessment of the feasibility of implementing the intervention'}, {'measure': 'EuroQoL-5 dimensions', 'timeFrame': 'Up to 12 weeks', 'description': 'Standardized measure of health-related quality of life used to generate patient utilities (will report lower decisional conflict, greater decision preparation, greater intention to stop smoking, and be more likely to make an attempt to stop smoking.)'}, {'measure': 'Costs of implementing any smoking cessation plus shared decision making intervention', 'timeFrame': 'Up to 12 weeks', 'description': 'Costs of personnel, hardware, and delivering materials to participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['current smoker', 'health care provider', 'primary care doctor'], 'conditions': ['Smoking', 'Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '36878389', 'type': 'DERIVED', 'citation': 'Lowenstein LM, Shih YT, Minnix J, Lopez-Olivo MA, Maki KG, Kypriotakis G, Leal VB, Shete SS, Fox J, Nishi SP, Cinciripini PM, Volk RJ. A protocol for a cluster randomized trial of care delivery models to improve the quality of smoking cessation and shared decision making for lung cancer screening. Contemp Clin Trials. 2023 May;128:107141. doi: 10.1016/j.cct.2023.107141. Epub 2023 Mar 5.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.', 'detailedDescription': "PRIMARY OBJECTIVE:\n\nI. Test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening.\n\nSECONDARY OBJECTIVES:\n\nI. Evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from Centers for Medicare \\& Medicaid Services (CMS) for the lung cancer screening patient counseling and shared decision making visit.\n\nII. Conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study.\n\nOUTLINE: Participants are randomized to 1 of 2 groups.\n\nGROUP I (CENTRALIZED CARE): Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.\n\nGROUP II (USUAL CARE): Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.\n\nAfter completion of study, participants are followed up at 1, 8, and 12 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PATIENTS: Primary care patients\n* PATIENTS: Upcoming primary care office visit\n* PATIENTS: Current smoker\n* PATIENTS: 30 plus (+) pack-year smoking history\n* PATIENTS: English-speaking\n* PROVIDERS: Primary health care providers\n* PROVIDERS: Provide care to adults\n\nExclusion Criteria:\n\n* PATIENTS: History of lung cancer by self-report'}, 'identificationModule': {'nctId': 'NCT04200534', 'briefTitle': 'Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial', 'orgStudyIdInfo': {'id': '2019-0265'}, 'secondaryIdInfos': [{'id': 'NCI-2019-05127', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2019-0265', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (centralized care strategy)', 'description': 'Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.', 'interventionNames': ['Drug: Nicotine Patch', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Other: Tobacco Cessation Counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (usual care)', 'description': 'Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.', 'interventionNames': ['Other: Best Practice', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive usual care counseling', 'armGroupLabels': ['Group II (usual care)']}, {'name': 'Nicotine Patch', 'type': 'DRUG', 'otherNames': ['NicoDerm CQ', 'Nicotine Skin Patch', 'Nicotine Transdermal Patch'], 'description': 'Given nicotine patches', 'armGroupLabels': ['Group I (centralized care strategy)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (centralized care strategy)', 'Group II (usual care)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (centralized care strategy)', 'Group II (usual care)']}, {'name': 'Tobacco Cessation Counseling', 'type': 'OTHER', 'description': 'Receive counseling over the phone', 'armGroupLabels': ['Group I (centralized care strategy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555-0565', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75708', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Tyler', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Robert J Volk', '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'}, {'name': 'Cancer Prevention Research Institute of Texas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}