Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT07228234
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Mammography Communication Approaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'This is a 2 x 2 +1 randomized factorial design. Participants will be randomly assigned to 1 of 5 experimental conditions, which vary (1) whether screening outcomes are referred to as "benefits and harms" vs. "outcomes that can happen with screening", and (2) the presence or absence of information about improvements in breast cancer treatment and survivability. In a 5th arm, a control condition, participants receive basic information about what mammography is (which is also information received in all other conditions).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1900}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2025-11-11', 'studyFirstSubmitQcDate': '2025-11-12', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skepticism toward the screening message', 'timeFrame': 'Participant experience entails a one-time survey. This outcome is measured in that survey, immediately after participants read information about mammography screening.', 'description': 'Skepticism toward the screening message is assessed using the RED scale, consisting of 11 questions each measured on a 7-point Likert scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Communication', 'Mammography'], 'conditions': ['The Focus of This Study is to Identify How Different Approaches to Mammography Communication Affect Skepticism Toward Mammography Evidence']}, 'descriptionModule': {'briefSummary': 'This is a randomized online experiment testing different methods for communicating about the benefits and harms of breast cancer screening. Participants will be randomly assigned to experimental conditions which vary whether screening outcomes are referred to as "benefits and harms" vs. "outcomes that can happen with screening", and vary the presence or absence of information about improvements in breast cancer survivability. In a control condition, participants receive basic information about what mammography is (which is also information received in all other conditions). Primary outcomes include skepticism toward the information presented, and screening intentions.', 'detailedDescription': 'This is a randomized online experiment testing different methods for communicating about the benefits and harms of breast cancer screening. Participants will be randomly assigned to 1 of 5 experimental conditions, in a 2 x 2 + 1 factorial design, which vary (1) whether screening outcomes are referred to as "benefits and harms" vs. "outcomes that can happen with screening", and (2) the presence or absence of information about improvements in breast cancer treatment and survivability. In a 5th arm, a control condition, participants receive basic information about what mammography is (which is also information received in all other conditions). Primary outcomes include skepticism toward the information presented, and screening intentions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '39 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, age 39-49\n\nExclusion Criteria:\n\n* No history of breast cancer, no known BRCA1/2 gene mutation'}, 'identificationModule': {'nctId': 'NCT07228234', 'briefTitle': 'Evaluating Mammography Communication Approaches', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Evaluating Mammography Communication Approaches', 'orgStudyIdInfo': {'id': '25-0635'}, 'secondaryIdInfos': [{'id': 'R37CA254926', 'link': 'https://reporter.nih.gov/quickSearch/R37CA254926', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control condition', 'description': 'Participants receive basic information about what mammography screening is', 'interventionNames': ['Other: No intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Harm/benefit language, survivability information', 'description': 'Outcomes of screening are referred to as "harms" and "benefits"; information about breast cancer survivability is included', 'interventionNames': ['Other: Harm/benefit language vs. outcomes that can happen', 'Other: Breast cancer survivability information']}, {'type': 'EXPERIMENTAL', 'label': 'Harm/benefit language, no survivability information', 'description': 'Outcomes of screening are referred to as "harms" and "benefits"; information about breast cancer survivability is not included', 'interventionNames': ['Other: Harm/benefit language vs. outcomes that can happen']}, {'type': 'EXPERIMENTAL', 'label': 'Outcomes that can happen language, survivability information', 'description': 'Outcomes of screening are referred to as "outcomes that can happen"; information about breast cancer survivability is included', 'interventionNames': ['Other: Harm/benefit language vs. outcomes that can happen', 'Other: Breast cancer survivability information']}, {'type': 'EXPERIMENTAL', 'label': 'Outcomes that can happen language, no survivability information', 'description': 'Outcomes of screening are referred to as "outcomes that can happen"; information about breast cancer survivability is not included', 'interventionNames': ['Other: Harm/benefit language vs. outcomes that can happen']}], 'interventions': [{'name': 'Harm/benefit language vs. outcomes that can happen', 'type': 'OTHER', 'description': 'Information about mortality benefit, false positives and overdiagnosis are referred to throughout the communication as either "harms" and "benefits" or "outcomes that can happen".', 'armGroupLabels': ['Harm/benefit language, no survivability information', 'Harm/benefit language, survivability information', 'Outcomes that can happen language, no survivability information', 'Outcomes that can happen language, survivability information']}, {'name': 'Breast cancer survivability information', 'type': 'OTHER', 'description': 'Information about improvements over time in the survivability of breast cancer is provided vs. not', 'armGroupLabels': ['Harm/benefit language, survivability information', 'Outcomes that can happen language, survivability information']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'This is the control condition in which only basic information about mammography screening.', 'armGroupLabels': ['Control condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Colorado Anschutz', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Laura D Scherer, PhD', 'role': 'CONTACT', 'email': 'laura.scherer@cuanschutz.edu', 'phone': '303-724-3278'}, {'name': 'Tamar Parmet, MA', 'role': 'CONTACT', 'email': 'tamar.parmet@cuanschutz.edu', 'phone': '303-724-3278'}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io/6m4y8/overview', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'This information will be made publicly available on the Open Science Framework prior to publishing the a manuscript from these data.', 'ipdSharing': 'YES', 'description': 'Although these data are anonymized, data will be checked for any potentially identifying information. Any such information will be removed from the data prior to data sharing. The full data (sans potential identifiers) will be made publicly available on the Open Science Framework.', 'accessCriteria': 'Anyone will be able to access the IPD via the Open Science Framework.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}