Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-30 @ 12:08 PM
Study NCT ID:
NCT01184534
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2010-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimedia Patient Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D014743', 'term': 'Videotape Recording'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}, {'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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-11', 'studyFirstSubmitDate': '2010-08-17', 'studyFirstSubmitQcDate': '2010-08-18', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Response to Subjective Anxiety Surveys', 'timeFrame': '1 day (pre and post lung biopsy procedure)', 'description': 'Subjective anxiety as measured on pre procedure and post procedure patient surveys.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung Biopsy', 'Multimedia patient education tool', 'Multimedia Education Tool', 'Computed tomography guided lung biopsy', 'Computerized Tomography', 'CT', 'Questionnaire', 'Lung nodules'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': 'Objective:\n\nTo compare changes in patient anxiety levels between groups of patients who either were or were not exposed to an informative multimedia patient education tool, in order to determine how the addition of such a multimedia tool will affect this parameter. Specifically, the study will focus on subjective anxiety as measured on pre procedure and post procedure patient surveys as detailed under study components.', 'detailedDescription': 'If you agree to take part in this study, you will complete a questionnaire that asks how you feel before the procedure. It will take about 5 minutes to complete.\n\nAfter you have completed the questionnaire, you will be randomly assigned (as in the flip of a coin) to Group 1 or Group 2. You will have an equal chance of being in either group.\n\nIf you are in Group 1, you will receive routine information before the lung biopsy and you will watch a video on a handheld or laptop machine with headphones. The video is designed to help you understand the biopsy procedure. This video should last about 5 minutes. You will then complete a questionnaire that asks how you feel after watching the video. It will take about 5 minutes to complete.\n\nIf you are in Group 2, you will receive routine information before the lung biopsy. You will then complete another questionnaire that asks how you feel before the procedure. It will take about 5 minutes to complete.\n\nAfter your routine lung biopsy, both groups will complete a questionnaire that asks how you feel after the procedure. It will take about 5 minutes to complete.\n\nFor Group 1, the total time to complete the questionnaires and watch the video will be 20 minutes.\n\nFor Group 2, the total time to complete the questionnaires will be 15 minutes.\n\nLength of Study:\n\nYour participation in this study will be over once you complete the questionnaire after your lung biopsy.\n\nThis is an investigational study.\n\nUp to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'UT MD Anderson Cancer Center Patients scheduled for a computed tomography (CT) guided lung biopsy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Scheduled for a computed tomography (CT) guided lung biopsy\n2. Literate English-speaking\n\nExclusion Criteria:\n\n1. Refusal to participate\n2. Current diagnosis of psychosis, dementia or other mentally altered state.\n3. Monitored anesthesia care (MAC) or general endotracheal anesthesia (GETA) during the procedure.\n4. Patients who are clinically diagnosed as hearing and visually impaired.\n5. Patients who have had prior image guided biopsies in our department.'}, 'identificationModule': {'nctId': 'NCT01184534', 'briefTitle': 'Multimedia Patient Education', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Increasing Patient Preparedness for the Procedural Experience and Improving Qualitative Outcomes Through Patient Education', 'orgStudyIdInfo': {'id': '2010-0397'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Questionnaires + Video', 'interventionNames': ['Behavioral: Video']}, {'label': 'Questionnaires', 'interventionNames': ['Behavioral: Questionnaires']}], 'interventions': [{'name': 'Video', 'type': 'BEHAVIORAL', 'description': '5 minute multimedia presentation (video)', 'armGroupLabels': ['Questionnaires + Video']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': '2 questionnaires pre and post procedure taking approximately 15 minutes each to complete.', 'armGroupLabels': ['Questionnaires']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Stephen McRae, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT MD Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}