Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT06098118
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2023-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C566113', 'term': 'Progressive Encephalomyelitis with Rigidity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability', 'timeFrame': 'Within 1 day, post-intervention', 'description': 'Acceptability e-scale,72 a 6-item measure for electronically-delivered interventions'}], 'secondaryOutcomes': [{'measure': 'Knowledge', 'timeFrame': 'Immediately pre-intervention, within 1 day post-intervention', 'description': '10 Knowledge items summed to measure understanding of clinical screening, alternatives, main benefits/risks'}, {'measure': 'Decisional Conflict', 'timeFrame': 'Immediately pre-intervention, within 1 day post-intervention', 'description': 'The "SURE" measure, a 4-item validated checklist to assess decisional conflict, including benefits and risks of test'}, {'measure': 'Screening self-efficacy', 'timeFrame': 'Immediately pre-intervention, within 1 day post-intervention', 'description': '10-item validated scale measuring self efficacy in obtaining mammography with summed score, range 5-50'}, {'measure': 'Screening Intentions', 'timeFrame': 'Immediately pre-intervention, within 1 day post-intervention', 'description': '15-point validated scale measuring intentions and 1 decision question (yes/no/unsure)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['per- and polyfluoroalkyl substances', 'breast cancer screening', 'decision aid', 'risk assessment'], 'conditions': ['Breast Cancer Screening']}, 'descriptionModule': {'briefSummary': 'This community-engaged research project will test an adapted online breast cancer screening decision aid to address the needs of women living in an area where environmental contamination has increased concern about breast cancer risk. It will provide novel data on individual experiences with breast cancer risk assessment and decisional determinants of screening choices in a community disproportionately impacted by industrial pollution.', 'detailedDescription': 'Environmental contamination is increasingly recognized as a critical driver of cancer disparities, and communities impacted by industrial pollution experience greater risk of cancer and higher cancer worry which complicates health decision making. Recently the National Academies of Science Engineering and Medicine (NASEM) released guidance suggesting that per- and polyfluoroalkyl substances (PFAS) are suggestively associated with breast cancer risk and that individuals with moderate to high blood concentrations of these chemicals should screen for breast cancer according to age and other risk factors as recommended by the US Preventive Services Task Force (USPSTF). Mammography screening guidelines for women in their 40s increasingly call for the use of risk assessment tools to guide screening initiation and imaging intervals (e.g. every year vs. every two years), but current tools do not address environmental risk factors that can contribute to breast cancer risk. This poses a particular challenge in communities where there is a real or perceived increased risk of breast cancer stemming from an environmental contamination concern. There are currently no decision tools tailored to help women living in such communities with their decisions about breast cancer screening. Therefore, the goal of the proposed work is to test an adapted online decision aid to incorporate environmental risk messaging to increase informed breast cancer screening decisions for women 40-49 years of age living in the greater Merrimack, New Hampshire area, where known and ongoing PFAS contamination exists. In partnership with Merrimack Citizens for Clean Water, we will distribute a community survey among screening-eligible women to test the new risk messaging within the decision aid (n=100) and establish acceptability in an open-label, single arm trial. The proposed research will contribute novel data on community-driven priorities for information about environmental contaminants that may affect breast cancer risk assessment and screening decisions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '39 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females aged 39-49\n* No personal history of breast cancer,\n* No mammogram in the prior 12 months\n* Resident of Merrimack, Hillsborough, Rockingham or Bennington counties\n\nExclusion Criteria:\n\n* History of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ\n* Cognitive impairment impeding the ability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06098118', 'briefTitle': 'Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS', 'organization': {'class': 'OTHER', 'fullName': 'Trustees of Dartmouth College'}, 'officialTitle': 'Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by Per- and Polyfluoroalkyl Substances (PFAS)', 'orgStudyIdInfo': {'id': 'STUDY00032987'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decision Aid', 'description': 'Participants will receive the adapted MyMammogram decision aid that includes environmental risk information.', 'interventionNames': ['Behavioral: MyMammogram decision aid']}], 'interventions': [{'name': 'MyMammogram decision aid', 'type': 'BEHAVIORAL', 'description': 'An online breast cancer screening decision aid that includes personalized risk assessment, information on benefits and risks of mammography screening, values clarification, outcome expectancies, and a summative document with participant responses.', 'armGroupLabels': ['Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03755', 'city': 'Hanover', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth College', 'geoPoint': {'lat': 43.70229, 'lon': -72.28954}}], 'overallOfficials': [{'name': 'Christine M Gunn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth College, Geisel School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available after primary paper is published and for up to 3 years.', 'ipdSharing': 'YES', 'description': 'Individual data that has been de-identified will be made available upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trustees of Dartmouth College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Christine M. Gunn', 'investigatorAffiliation': 'Trustees of Dartmouth College'}}}}