Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-27 @ 10:34 AM
Study NCT ID:
NCT02282969
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2014-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PCORI-CER-1306-03385 Lung Cancer Screening Decision Aid Development and Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 620}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2014-10-31', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Informed Decisions About Lung Cancer Screening (Data from interviews and questionnaires reviewed to assess participant knowledge)', 'timeFrame': '1 Month', 'description': 'Data from interviews and questionnaires reviewed to assess participant knowledge regarding lung cancer screening and decision aid.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Prevention', 'Smokers', 'Quit smoking', 'Interviews', 'Questionnaires', 'Surveys', 'Lung cancer screening', 'Patient decision aid'], 'conditions': ['Health Knowledge, Attitudes, Practice']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nThis protocol addresses the first phase of a larger project funded by the Patient-Centered Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer screening with low-dose computed tomography (CT). A separate IRB protocol will be submitted for the larger, comparative study. In this initial development phase, our prototype patient decision aid will be updated to reflect current guidelines about lung cancer screening. The updated aid will then be pilot-tested in a new sample of patients. In addition, several of the study measures will be refined and further developed in preparation for the larger study.\n\nThe specific aims of the measures and decision aid development phase of this project are as follows:\n\nUpdate the aid to reflect current screening guidelines and refine the aid via cognitive testing with patients/smokers; and pilot test the updated aid for acceptability with patients/smokers.\n\nModify our current measure of lung cancer knowledge, conduct cognitive testing of the new measure with patients/smokers, and evaluate the reliability of the new measure in a sample patients/smokers.', 'detailedDescription': 'Cognitive and Pilot Testing:\n\nIf you agree to take part in this study, you will take part in an interview with a member of the research staff. The interviewer will take notes of your responses. First, you will be asked some questions about you, like your age, sex, race, and education level. Then you will be asked to look at some educational materials about lung cancer screening. These could be written information, animations, graphics, videos, or questionnaires. You may be asked questions about:\n\n* Lung cancer and lung cancer screening\n* The length of the materials\n* The balance of the information found in the materials\n\nThe study interview will take place in person at MD Anderson and will take between 1 and 1 ½ hours.\n\nYour participation on this study will be over once the interview is complete.\n\nThis is an investigational study.\n\nUp to 50 participants will be enrolled in this part of the study. All will take part at MD Anderson, UTMB, the Galveston community, or tobacco-related community events.\n\nMeasures Reliability Study:\n\nIf you agree to take part in this study, you will complete a questionnaire 2 times. The questionnaire will ask about:\n\n* Lung cancer\n* Lung cancer screening\n* Making decisions about screening\n* Your age, race, gender, and level of education\n\nYou will complete the first questionnaire in person. It will take about 20 minutes to fill out. Then, about 1 month later, you will be asked to fill out the questionnaire again.\n\nThe second time you can come in person, or fill out the questionnaire by mail or telephone. Your participation will be over when the second questionnaire is complete.\n\nThis is an investigational study.\n\nUp to 150 participants will be enrolled in this part of the study. All will take part at MD Anderson, UTMB, the Galveston community, or tobacco-related community events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants recruited from Houston and Galveston areas.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women 55 to 80 years of age.\n2. Participants must speak English.\n3. Current smoker or quit smoking within the past 15 years.\n\nExclusion Criteria:\n\n1\\. History of lung cancer.'}, 'identificationModule': {'nctId': 'NCT02282969', 'briefTitle': 'PCORI-CER-1306-03385 Lung Cancer Screening Decision Aid Development and Testing', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Promoting Informed Decisions About Lung Cancer Screening: Decision Aid Update and Measures Development', 'orgStudyIdInfo': {'id': 'PA14-0072'}, 'secondaryIdInfos': [{'id': 'CER-1306-03385', 'type': 'OTHER_GRANT', 'domain': 'Patient Centered Outcomes Research Institute'}, {'id': 'NCI-2022-00832', 'type': 'OTHER', 'domain': 'Clinical Trials Reporting Program (CTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung Cancer Screening Decision Aids', 'description': 'Participants are asked to look over education materials about lung cancer screening, and interviewed. Some participants will look at a video patient decision aid, with an interview and questionnaire completion. Some participants complete lung cancer screening knowledge questionnaire at first visit, and then again in one month.', 'interventionNames': ['Behavioral: Interviews', 'Behavioral: Questionnaires']}], 'interventions': [{'name': 'Interviews', 'type': 'BEHAVIORAL', 'description': 'Interviews performed by study staff encompassing lung cancer screening and patient decision aids.', 'armGroupLabels': ['Lung Cancer Screening Decision Aids']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'otherNames': ['Surveys'], 'description': 'Questionnaires completed after viewing patient decision aid video. Questionnaires also completed regarding lung cancer screening knowledge at first visit, then again in one month.', 'armGroupLabels': ['Lung Cancer Screening Decision Aids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Texas Medical Branch at Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas MD 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 Volk, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}, {'name': 'Suzanne Linder, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Medical Branch at Galveston'}, {'name': 'Paul Cinciripini, PHD, MS, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}