Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT03891602
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2019-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'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': 'D003523', 'term': 'Cycloserine'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lisa.carterbawa@hmh-cdi.org', 'phone': '2018803443', 'title': 'Lisa Carter-Bawa, PhD, MPH, APRN, ANP-C, FAAN', 'organization': 'Hackensack Meridian Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Within 12 months', 'description': 'Self reported adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Clinicians', 'description': 'Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 0, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Smokers/Former Smokers', 'description': 'Current smoker or former smoker who has quit within the past 15 years', 'otherNumAtRisk': 529, 'deathsNumAtRisk': 529, 'otherNumAffected': 0, 'seriousNumAtRisk': 529, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Key Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '529', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Smokers/Former Smokers', 'description': 'Current smoker or former smoker who has quit within the past 15 years'}], 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '15.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline (study enrollment)', 'description': 'Decisional Quality was measured using the multidimensional Decisional Conflict Scale, a 16-item Likert-response scale that was modified by the investigators for the lung cancer screening context. The total score ranging from 0 to 64. This total score is commonly transformed into a standardized score that falls within a 0 to 100 range. Decisional quality measured on this numeric scale from which lower scores represent lower decisional conflict and, therefore, higher decisional quality. Scores below 25 have been associated with low decisional conflict.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clinicians', 'description': "Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients\n\nPrimary Care Clinicians' Lung Cancer Screening Survey: Includes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines."}, {'id': 'FG001', 'title': 'Smokers/Former Smokers', 'description': 'Current smoker or former smoker who has quit within the past 15 years'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '529'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '529'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clinicians', 'description': 'Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients'}, {'id': 'BG001', 'title': 'Smokers/Former Smokers', 'description': 'Current smoker or former smoker who has quit within the past 15 years'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '529', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.4', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '66.4', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Clinicians who participated in the study were only asked for their age as a categorical variable as a result we cannot provide mean and standard deviation.'}, {'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '≥ 18 and ≤ 50 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': '> 50 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '574', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '294', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}]}, {'title': 'Prefer not to say', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '517', 'groupId': 'BG001'}, {'value': '637', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '542', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Clinicians and patients included in the study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-31', 'size': 767065, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-11T11:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 654}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2019-03-25', 'resultsFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-14', 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Key Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Quality', 'timeFrame': 'at baseline (study enrollment)', 'description': 'Decisional Quality was measured using the multidimensional Decisional Conflict Scale, a 16-item Likert-response scale that was modified by the investigators for the lung cancer screening context. The total score ranging from 0 to 64. This total score is commonly transformed into a standardized score that falls within a 0 to 100 range. Decisional quality measured on this numeric scale from which lower scores represent lower decisional conflict and, therefore, higher decisional quality. Scores below 25 have been associated with low decisional conflict.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoker', 'Memorial Sloan Kettering Cancer Center'], 'conditions': ['Smoking', 'Smoking, Tobacco', 'Smoking, Cigarette', 'Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about discussion between clinicians and their patients related to lung screening. Survey answers will be collected from both clinicians and their patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All recruitment will take place at Kaiser Permanente Washington.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCLINICIANS:\n\n* Clinician (physician, nurse practitioner, or physician assistant)\n* Practicing in a KPWA primary care clinic\n* Having a patient panel with \\>/= 10 lung cancer screening eligible patients\n\nPATIENTS (Quantitative Phase):\n\n* Age 55-80 years\n* \\>/= 30 pack-year tobacco smoking history\n* Current smoker or former smoker who has quit within the past 15 years\n* Documented SDM lung cancer screening discussion during a recent clinic visit\n\nExclusion Criteria:\n\nPATIENTS:\n\n* Significant comorbidities (Charlson Comorbidity Index \\>/=3)\n* Lung cancer diagnosis'}, 'identificationModule': {'nctId': 'NCT03891602', 'acronym': 'DECIDE', 'briefTitle': 'DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement', 'organization': {'class': 'OTHER', 'fullName': 'Hackensack Meridian Health'}, 'officialTitle': 'Using a Mixed Methods Approach to Understand Shared Decision-Making in Lung Cancer Screening', 'orgStudyIdInfo': {'id': '19-007'}, 'secondaryIdInfos': [{'id': 'Pro2022-0776', 'type': 'OTHER', 'domain': 'Hackensack Meridian Health IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinicians', 'description': 'Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients', 'interventionNames': ["Behavioral: Primary Care Clinicians' Lung Cancer Screening Survey"]}, {'label': 'Smokers/Former Smokers', 'description': 'Current smoker or former smoker who has quit within the past 15 years', 'interventionNames': ['Behavioral: Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale)', 'Behavioral: Patient Trust in the Medical', 'Behavioral: Decision Conflict Scale (DCS) - Lung Cancer Screening', 'Behavioral: Shared Decision Making Questionnaire (SDM-Q)- Patient', 'Behavioral: Stage of Readiness for Smoking Cessation - Contemplation Ladder']}], 'interventions': [{'name': 'Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale)', 'type': 'BEHAVIORAL', 'description': "Perceived Smoking-Related Stigma will be measured using the 5-item Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale). The response scale is 1 = strongly disagree, to 4 = strongly agree, and scores range from 5 to 25 (high stigma). Cronbach's alphas were 0.75 to 0.89 in prior studies.", 'armGroupLabels': ['Smokers/Former Smokers']}, {'name': 'Patient Trust in the Medical', 'type': 'BEHAVIORAL', 'description': 'Medical Mistrust will be measured using the 5-item Patient Trust in the Medical Profession Scale.80 The five-point Likert responses measure the extent to which patients perceive their clinician to be honest, caring more about convenience, thorough and careful, and trusted. The range of scores is 5 to 25 (higher mistrust). Reliability and validity have been well established with a Cronbach"s alpha of 0.84.', 'armGroupLabels': ['Smokers/Former Smokers']}, {'name': 'Decision Conflict Scale (DCS) - Lung Cancer Screening', 'type': 'BEHAVIORAL', 'otherNames': ['DCS'], 'description': 'The DCS is a 16-item Likert-response item scale that has been modified for the lung cancer screening and smoking cessation contexts. The DCS was developed by O"Connor,74-75 and validated in many health decisions including breast cancer screening with Cronbach"s alphas ranging from 0.78 to 0.81. 74-75 Despite its name, the DCS measures more than decision conflict to encompass personal perceptions of perceived decision-making quality such as feeling the choice is informed, values based, and likely to be implemented as well as expressing satisfaction with the decision. 74-75 The DCS is comprised of items with response options ranging from 1 (strongly disagree) to 5 (strongly agree). The items are summed to total scale score with lower scores reflective of higher decision conflict and higher scores reflective of lower decision conflict.', 'armGroupLabels': ['Smokers/Former Smokers']}, {'name': 'Shared Decision Making Questionnaire (SDM-Q)- Patient', 'type': 'BEHAVIORAL', 'otherNames': ['SDM-Q-9'], 'description': 'Shared Decision Making Process will be measured from the patient perspective using the 9-item Shared Decision Making Questionnaire (SDM-Q-9),77 which has been validated with a Cronbach"s alpha of 0.94.', 'armGroupLabels': ['Smokers/Former Smokers']}, {'name': 'Stage of Readiness for Smoking Cessation - Contemplation Ladder', 'type': 'BEHAVIORAL', 'description': 'Among current smokers', 'armGroupLabels': ['Smokers/Former Smokers']}, {'name': "Primary Care Clinicians' Lung Cancer Screening Survey", 'type': 'BEHAVIORAL', 'description': 'Includes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines.', 'armGroupLabels': ['Clinicians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101-1466', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente Washington Health Research Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jamie Ostroff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}, {'name': 'Lisa Carter-Bawa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hackensack Meridian Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Indiana University', 'class': 'OTHER'}, {'name': 'University of North Carolina', 'class': 'OTHER'}, {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, {'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director | Cancer Prevention Precision Control Institute', 'investigatorFullName': 'Lisa Carter-Bawa, PhD', 'investigatorAffiliation': 'Hackensack Meridian Health'}}}}