Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT04424758
Status:
UNKNOWN
Last Update Posted:
2020-07-15
First Post:
2020-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing Video Information About Mammography Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-28', 'size': 520546, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-02T05:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'See protocol'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'See protocol'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2020-05-28', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Choice: proportion of participants in favor of mammography screening', 'timeFrame': 'One month', 'description': 'The primary outcome in the study is choice. A possible effect of the intervention on choice will be examined by comparing the proportion of participants in favor of screening (on the individual level and societal level respectively) between the intervention arm and the control arm. One question addressing the societal choice and one question addressing the individual choice is included in our questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Response duration: time', 'timeFrame': 'One month', 'description': 'Response duration is registered for all participants in the online survey. Mean response duration will be calculated in both the intervention arm and control arm.'}, {'measure': 'Acceptability of the video: percentage of participants finding the video to be neutral, in favor of or against mammography screening.', 'timeFrame': 'One month', 'description': 'Percentages of the participants finding the video to be neutral, in favor of or against mammography screening will be calculated in the intervention arm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study examines how video information about mammography screening effect participants knowledge opinions and choice about screening.', 'detailedDescription': 'This study will be conducted as a single site parallel-arm, 1:1 randomized controlled trial (RCT) through a web-based quantitative survey uploaded in online forums. Participants will be randomized to either the intervention group (video information about mammography screening followed by a survey about mammography screening) or the control group (video information about energy systems followed by the same survey). The survey computer programme will randomly assign each respondent to either the intervention arm or the control arm in the beginning of the survey.\n\nThe allocation will be concealed from the researchers. The survey computer programme will deliver the intervention right after randomization. Participants will be aware of the allocation. However, they do not know about the study design. Data analysts will be kept blinded to the allocation.\n\nChoice, knowledge and opinions related to mammography screening will be compared between the control group and the intervention group at one timepoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants eligible for the study includes all men and women age 18-75.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04424758', 'briefTitle': 'Testing Video Information About Mammography Screening', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Testing Video Information About Mammography Screening in a Randomized Design', 'orgStudyIdInfo': {'id': '2204MDJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Receives information about mammography screening through a video. The video was developed with the goal of informing about mammography screening in a societal perspective using best available evidence.', 'interventionNames': ['Other: Video information about mammography screening']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Receives information about energy systems through a video. The video does not contain any information related to mammography screening.', 'interventionNames': ['Other: Video information about smart energy systems']}], 'interventions': [{'name': 'Video information about mammography screening', 'type': 'OTHER', 'description': 'A video informing about mammography screening', 'armGroupLabels': ['Intervention group']}, {'name': 'Video information about smart energy systems', 'type': 'OTHER', 'description': 'A video informing about smart energy systems', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1014', 'city': 'Copenhagen', 'state': 'Capital', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Manja D Jensen, MD', 'role': 'CONTACT', 'email': 'madj@sund.ku.dk', 'phone': '0045-35333123'}, {'name': 'John Brodersen, MD, phd', 'role': 'CONTACT', 'email': 'jobr@sund.ku.dk'}], 'facility': 'University of Copenhagen, Section of General Practice', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Manja Jensen, MD', 'role': 'CONTACT', 'email': 'madj@sund.ku.dk', 'phone': '0045-35333123'}, {'name': 'John Brodersen, MD, PhD', 'role': 'CONTACT', 'email': 'jobr@sund.ku.dk', 'phone': '0045-35333123'}], 'overallOfficials': [{'name': 'Manja Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Section of General Practice, University of Copenhagen'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be stored until 2050.', 'ipdSharing': 'YES', 'description': 'When the study is completed, access to study data will be provided by the PI on request.', 'accessCriteria': 'Data will be provided by the PI on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Medical doctor, PhD-student', 'investigatorFullName': 'Manja Dahl Jensen', 'investigatorAffiliation': 'University of Copenhagen'}}}}