Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2026-03-09 @ 4:50 AM
Study NCT ID:
NCT02151032
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2014-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal 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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gist and Verbatim Knowledge for a Colorectal Cancer Screening Program', 'timeFrame': '1 day', 'description': 'The fixed effects analysis of variance (ANOVA) will utilize a factorial design with two factors: content presentation type (standard, animated, interactive) and numeracy status (high and low based on US population scores). Main dependent measures are gist and verbatim knowledge. Gist and verbatim knowledge scores (0-100) looked at separately as well as combined.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'Colorectal cancer screening', 'Multimedia', 'Booklet', 'Pamphlet', 'Audio CD', 'Video with animated images', 'Video with non-moving images', 'Questionnaires', 'Surveys'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '31795820', 'type': 'DERIVED', 'citation': 'Housten AJ, Kamath GR, Bevers TB, Cantor SB, Dixon N, Hite A, Kallen MA, Leal VB, Li L, Volk RJ. Does Animation Improve Comprehension of Risk Information in Patients with Low Health Literacy? A Randomized Trial. Med Decis Making. 2020 Jan;40(1):17-28. doi: 10.1177/0272989X19890296. Epub 2019 Dec 3.'}, {'pmid': '29587709', 'type': 'DERIVED', 'citation': 'Housten AJ, Lowenstein LM, Hoover DS, Leal VB, Kamath GR, Volk RJ. Limitations of the S-TOFHLA in measuring poor numeracy: a cross-sectional study. BMC Public Health. 2018 Mar 27;18(1):405. doi: 10.1186/s12889-018-5333-9.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to compare how people who are 45-75 years old respond to 3 different versions of a program about screening tests for colorectal cancer. Researchers want to use this study as part of a long-term project to learn the best ways to communicate health information to patients.', 'detailedDescription': 'If you agree to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 3 study groups. Neither you nor the study staff will be able to choose which group you will be in:\n\n* If you are in Group 1, you will read a booklet about colorectal cancer screening tests. While reading the booklet, you will also listen to an audio CD that will narrate the booklet.\n* If you are in Group 2, you will watch a video with non-moving images about colorectal cancer screening tests on an iPad.\n* If you are in Group 3, you will watch a video with animated images about colorectal cancer screening tests on an iPad.\n\nYou will complete questionnaires before and after viewing the program that will contain questions about:\n\n* Your age and what language you speak\n* Your math and reading comprehension\n* Your knowledge of colorectal cancer and colorectal cancer screening\n* Your thoughts about colorectal cancer screening\n* Your opinions about this study, and\n* How well you understand the booklet/video you view as part of this study\n\nIt will take about 1 hour to complete all the questionnaires. In total, the study will take about 1 ½ to 2 hours to complete. After you have completed the questionnaires, your participation in the study will be over.\n\nThis is an investigational study.\n\nUp to 201 people will take part in this multicenter study. Up to 67 will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Participants from MD Anderson Cancer Prevention Center (CPC), Literacy Advance of Houston (LAH), Ephiphany Community Health Outreach Services (ECHOS), and Bethel's Heavenly Hands", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women 45 to 75 years of age.\n2. Participant must speak English.\n\nExclusion Criteria:\n\n1\\) Self-reported diagnosis of colon cancer.'}, 'identificationModule': {'nctId': 'NCT02151032', 'briefTitle': 'Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial', 'orgStudyIdInfo': {'id': '2011-0632'}, 'secondaryIdInfos': [{'id': '0619-1', 'type': 'OTHER_GRANT', 'domain': 'Foundation for Informed Medical Decision Making'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colorectal Cancer Screening Booklet + Audio CD', 'description': 'Participants read the booklet about colorectal cancer screening tests, and listen to an audio CD that will narrate the booklet. Questionnaire completion before and after viewing the program.', 'interventionNames': ['Behavioral: Booklet', 'Behavioral: Audio CD', 'Behavioral: Questionnaires']}, {'label': 'Video with Non-Moving Images on iPad', 'description': 'Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad. Questionnaire completion before and after viewing the program.', 'interventionNames': ['Behavioral: Video with Non-Moving Images', 'Behavioral: Questionnaires']}, {'label': 'Video with Animated Images on iPad', 'description': 'Participants watch a video with animated images about colorectal cancer screening tests on an iPad. Questionnaire completion before and after viewing the program.', 'interventionNames': ['Behavioral: Video with Animated Images', 'Behavioral: Questionnaires']}], 'interventions': [{'name': 'Booklet', 'type': 'BEHAVIORAL', 'otherNames': ['Pamphlet'], 'description': 'Participants read a booklet about colorectal cancer screening tests.', 'armGroupLabels': ['Colorectal Cancer Screening Booklet + Audio CD']}, {'name': 'Audio CD', 'type': 'BEHAVIORAL', 'description': 'Participants listen to an audio CD that will narrate the colorectal cancer screening tests booklet.', 'armGroupLabels': ['Colorectal Cancer Screening Booklet + Audio CD']}, {'name': 'Video with Non-Moving Images', 'type': 'BEHAVIORAL', 'description': 'Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad.', 'armGroupLabels': ['Video with Non-Moving Images on iPad']}, {'name': 'Video with Animated Images', 'type': 'BEHAVIORAL', 'description': 'Participants watch a video with animated images about colorectal cancer screening tests on an iPad.', 'armGroupLabels': ['Video with Animated Images on iPad']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'otherNames': ['Surveys'], 'description': 'Questionnaire completion before and after viewing the program.', 'armGroupLabels': ['Colorectal Cancer Screening Booklet + Audio CD', 'Video with Animated Images on iPad', 'Video with Non-Moving Images on iPad']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77035', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Bethel's Heavenly Hands", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77042', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Literacy Advance of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77071', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Ephiphany Community Health Outreach Services', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Robert Volk, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation for Informed Medical Decision Making', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}