Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 9:15 PM
Study NCT ID:
NCT07382557
Status:
RECRUITING
Last Update Posted:
2026-02-03
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptation and Pilot Testing of a Lung Cancer Screening Decision Aid for Patients From a Safety-Net Healthcare System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D017144', 'term': 'Focus Groups'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Adverse Events (AEs).', 'timeFrame': 'Through study completion; an average of 1 year', 'description': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study is to adapt and test a participant decision aid about lung cancer screening for use with patients in theHarris Health System (HHS).', 'detailedDescription': 'The study has two phases. In the first phase, the investigators will conduct a cultural and linguistic adaptation of a patient decision aid video on lung cancer screening for use with patients with low health literacy in English and Spanish. They will produce adapted decision aid videos and written educational materials about lung cancer screening. They will survey providers about their lung cancer screening practices, conduct focus groups to learn what patients want to know about screening, and perform cognitive interviews with patients to make sure the adapted videos and educational materials are easy to understand.\n\nIn the second phase, the investigators will test the adapted lung cancer screening decision aid videos in English and Spanish to determine acceptability and impact of the aids on decision making outcomes. Patients will be randomized to evaluate an adapted video decision aid intervention or a control condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 50-80 years of age\n2. Current smokers or smokers who have quit less than 15 years ago\n3. Speak either English or Spanish\n4. No history of lung cancer\n5. Family member of someone with a history of smoking AND lung cancer\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT07382557', 'briefTitle': 'Adaptation and Pilot Testing of a Lung Cancer Screening Decision Aid for Patients From a Safety-Net Healthcare System', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Adaptation and Pilot Testing of a Lung Cancer Screening Decision Aid for Patients From a Safety-Net Healthcare System', 'orgStudyIdInfo': {'id': '2022-0383'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Needs Assessment: Provider Survey (Aim 1)', 'description': 'Up to 200 physicians and other health professionals', 'interventionNames': ['Other: Surveys']}, {'type': 'OTHER', 'label': 'Needs Assessment: Patient/Family member Focus Groups (Aim 1)', 'description': 'Up to 20 participants who speak English or Spanish', 'interventionNames': ['Other: Focus groups']}, {'type': 'OTHER', 'label': 'Decision Aid Adaptation (Patient Cognitive Interviews (Aim 1)', 'description': 'Up to 40 participants who speak English or Spanish', 'interventionNames': ['Other: Cognitive Interviews']}, {'type': 'EXPERIMENTAL', 'label': 'Pilot Study: Intervention Patients (Aim 2)', 'description': 'Up to 50 participants (25 English speakers, 25 Spanish speakers)', 'interventionNames': ['Behavioral: Lung cancer screening decision aid video']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Pilot Study: Control Patients (Aim 2)', 'description': 'Up to 50 participants (25 English speakers, 25 Spanish speakers)', 'interventionNames': ['Behavioral: Colon cancer screening video']}], 'interventions': [{'name': 'Surveys', 'type': 'OTHER', 'description': 'Investigators will answer surveys about their lung cancer screening practices', 'armGroupLabels': ['Needs Assessment: Provider Survey (Aim 1)']}, {'name': 'Focus groups', 'type': 'OTHER', 'description': 'Participants will participate in focus groups about information they need in order to decide about lung cancer screening', 'armGroupLabels': ['Needs Assessment: Patient/Family member Focus Groups (Aim 1)']}, {'name': 'Cognitive Interviews', 'type': 'OTHER', 'description': 'Participants will participate in interviews about their understanding of the adapted video script', 'armGroupLabels': ['Decision Aid Adaptation (Patient Cognitive Interviews (Aim 1)']}, {'name': 'Lung cancer screening decision aid video', 'type': 'BEHAVIORAL', 'description': 'Participants take surveys before and after watching the intervention video', 'armGroupLabels': ['Pilot Study: Intervention Patients (Aim 2)']}, {'name': 'Colon cancer screening video', 'type': 'BEHAVIORAL', 'description': 'Participants take surveys before and after watching the control video', 'armGroupLabels': ['Pilot Study: Control Patients (Aim 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Volk, PHD', 'role': 'CONTACT', 'email': 'bvolk@mdanderson.org', 'phone': '713-563-2509'}, {'name': 'Robert Volk, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas M. D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Robert Volk, PHD', 'role': 'CONTACT', 'email': 'bvolk@mdanderson.org', 'phone': '(713) 563-2509'}], 'overallOfficials': [{'name': 'Robert Vok, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}