Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT06213532
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2024-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CONNECTing to LungCare
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The first cohort of participants will be enrolled on the Beta Arm or intervention development. Once developed, new participants will be randomized into Groups 1 and Groups 2.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 147}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2024-01-09', 'studyFirstSubmitQcDate': '2024-01-09', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'Up to 1 year', 'description': 'The percentage of participants who were contacted and joined the study will be reported.'}, {'measure': 'Retention rates', 'timeFrame': 'Up to 1 year', 'description': 'The percentage of participants who joined the study and completed the program will be reported.'}, {'measure': 'Adherence rates', 'timeFrame': 'Up to 1 year', 'description': 'The percentage of participants who joined the study and completed all tasks within the program will be reported.'}, {'measure': 'Overall time required to recruit to the target sample size (Feasibility Cohort)', 'timeFrame': 'Up to 1 year', 'description': 'The overall time in weeks required to recruit participants for the feasibility cohort will be reported.'}, {'measure': 'Number of eligible participants', 'timeFrame': 'Up to 1 year', 'description': 'The number of eligible participants required to recruit the required sample size will be reported'}], 'secondaryOutcomes': [{'measure': 'Smoking cessation rates', 'timeFrame': 'At 3 months', 'description': 'Will evaluate the impact of the intervention on smoking cessation rates. Rates of smoking cessation will be measured by self-report and validated by salivary cotinine levels.'}, {'measure': 'Lung cancer screening (LCS) rates', 'timeFrame': 'Up to 3 months', 'description': 'Rates of LCS will be evaluated through review of the electronic health record (EHR)'}, {'measure': 'Shared decision making about LCS', 'timeFrame': 'Up to 3 months', 'description': 'Evidence of shared decision-making conversation will be obtained through one week follow up phone call and with review of the EHR three months after the primary care physician visit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking Cessation', 'Cigarette Smoking-Related Carcinoma', 'Lung Carcinoma']}, 'descriptionModule': {'briefSummary': "This study evaluates a smoking cessation intervention (CONNECTing to LungCare) for improving shared decision-making conversations about smoking cessation and lung cancer screening between patients and providers. Shared decision making is a patient care model in which providers offer information regarding risks and benefits, patients express their values and preferences, and then healthcare decisions are jointly discussed between the patient and provider. Patient education, aided by decision support tools, can increase patients' knowledge, decrease their decisional conflict, promote decision making, and improve the patients' perception of risk. CONNECTing to LungCare is an interactive education intervention that addresses lung cancer screening and smoking cessation and provides participants with a tailored summary that may make them more likely to have shared decision-making discussions with their providers about smoking cessation and lung cancer screening.", 'detailedDescription': "PRIMARY OBJECTIVES:\n\nAim 1: Development of the smoking cessation and LCS intervention, CONNECTing to LungCare.\n\nAim 2: Test CONNECTing to Lung Care for Feasibility and Acceptability (N=120)\n\nAim 3: To qualitatively evaluate feasibility and acceptability of the intervention and study procedures from the perspectives of patients, providers, staff and administrators and other stakeholders.\n\nOUTLINE:\n\nBETA TESTING: Participants interact with the CONNECTing to LungCare intervention and provide feedback in support of intervention refinement.\n\nFEASIBILITY TRIAL: Participants are randomized to 1 of 2 groups.\n\nGROUP I: Participants receive the CONNECTing to LungCare intervention, including education about the benefits and risks of LCS and the importance of shared decision making, computerized assessments of the participant's smoking status, readiness to quit and concerns about quitting, and video segments tailored to the participant's responses to assessment questions, prior to their primary care appointment. Participants and their providers receive a tailored summary of the participant's concerns and barriers to quitting to enhance motivation for smoking cessation and shared decision making discussions. Participants then receive up to 3 follow-up phone calls over 10-15 minutes each encouraging them to follow up with their provider, to complete the shared decision-making conversation, obtain LCS if appropriate, and access smoking cessation resources. Participants may also receive brief, tailored follow-up text messages that include links to video segments or cessation resources 1-3 times weekly.\n\nGROUP II: Participants receive usual care from their provider at their primary care appointment.\n\nAfter completion of study intervention, participants are followed up at 1 and 3 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English, Spanish and Cantonese speaking\n* Age \\>= 18 years old\n* Primary care patients at the University of California, San Francisco (UCSF) General Internal Medicine (GIM) clinics\n* Must be current smokers and/or candidates for Lung Cancer Screening (LCS).\n\nKey Informant Interviews:\n\n\\- Must be working in one of the clinics participating in CONNECTing to LungCare.\n\nExclusion Criteria:\n\n* Not a current smoker'}, 'identificationModule': {'nctId': 'NCT06213532', 'briefTitle': 'CONNECTing to LungCare', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'CONNECTing to LungCare', 'orgStudyIdInfo': {'id': '226311'}, 'secondaryIdInfos': [{'id': 'NCI-2023-10506', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program (CTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Beta testing (CONNECTing to LungCare, feedback)', 'description': 'Participants interact with the CONNECTing to LungCare intervention and provide feedback in support of intervention refinement.', 'interventionNames': ['Behavioral: Smoking Cessation Intervention', 'Other: Survey Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Feasibility trial, Group I (CONNECTing to LungCare)', 'description': "Participants receive the CONNECTing to LungCare intervention, including education about the benefits and risks of LCS and the importance of shared decision making, computerized assessments of the participant's smoking status, readiness to quit and concerns about quitting, and video segments tailored to the participant's responses to assessment questions, prior to their primary care appointment. Participants and their providers receive a tailored summary of the participant's concerns and barriers to quitting to enhance motivation for smoking cessation and shared decision-making discussions. Participants then receive up to 3 follow-up phone calls over 10-15 minutes each encouraging them to follow up with their provider, to complete the shared decision-making conversation, obtain LCS if appropriate, and access smoking cessation resources. Participants may also receive brief, tailored follow-up text messages that include links to video segments or cessation resources 1-3 times weekly.", 'interventionNames': ['Behavioral: Smoking Cessation Intervention', 'Other: Saliva Collection', 'Other: Survey Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Feasibility trial, Group II (usual care)', 'description': 'Participants receive usual care from their provider at their primary care appointment.', 'interventionNames': ['Behavioral: Smoking Cessation Intervention', 'Other: Saliva Collection', 'Other: Survey Administration']}], 'interventions': [{'name': 'Smoking Cessation Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['CONNECTing to LungCare intervention'], 'description': 'Multimedia program administered either remotely or in person', 'armGroupLabels': ['Beta testing (CONNECTing to LungCare, feedback)', 'Feasibility trial, Group I (CONNECTing to LungCare)', 'Feasibility trial, Group II (usual care)']}, {'name': 'Saliva Collection', 'type': 'OTHER', 'otherNames': ['Biospecimen Collection', 'Specimen Sample', 'Saliva Sample'], 'description': 'Saliva samples will be collected from each participant', 'armGroupLabels': ['Feasibility trial, Group I (CONNECTing to LungCare)', 'Feasibility trial, Group II (usual care)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Beta testing (CONNECTing to LungCare, feedback)', 'Feasibility trial, Group I (CONNECTing to LungCare)', 'Feasibility trial, Group II (usual care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Van Le', 'role': 'CONTACT', 'email': 'Van.Le@ucsf.edu', 'phone': '877-827-3222'}, {'role': 'CONTACT', 'email': 'cancertrials@ucsf.edu'}, {'name': 'Judith Walsh-Cassidy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Van Le', 'role': 'CONTACT', 'email': 'Van.Le@ucsf.edu', 'phone': '877-827-3222'}], 'overallOfficials': [{'name': 'Judith Walsh-Cassidy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tobacco Related Disease Research Program', 'class': 'OTHER'}, {'name': 'Alere San Diego', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}