Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-22 @ 3:59 PM
Study NCT ID:
NCT03631758
Status:
COMPLETED
Last Update Posted:
2023-10-19
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of Evidence-based Information About Mammography on Breast Cancer Screening Decisions
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2018-08-13', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decisional Conflict Scale', 'timeFrame': 'Change from baseline to 6-mo', 'description': 'A validated scale in which items are summed and scored to create a total score. Scores range from 0 to 100, with higher scores indicating higher decisional conflict.'}], 'secondaryOutcomes': [{'measure': 'Decision quality', 'timeFrame': 'Change from baseline to 6-mo', 'description': 'Decision Quality Worksheet for Mammography'}, {'measure': 'Preparation for Decision Making Scale', 'timeFrame': 'Change from baseline to 6-mo', 'description': 'A validated scale, items are summed and scored to create a score of 0-100. Higher scores indicate higher preparation for decision making'}, {'measure': 'Screening behaviour', 'timeFrame': 'Change from baseline to 6-mo', 'description': 'Congruency between self-reported screening status and stated decision'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Screening', 'Mammography', 'Patient Decision Aid'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by women facing breast cancer screening decisions.', 'detailedDescription': 'Guidelines for breast screening in Canada are based on low-moderate quality evidence of effectiveness and screening is associated with potential harms. Patient Decision Aids (PDAs) are tools that assist users to understand treatment options, risks and benefits to align decisions with values and preferences. The investigators would now like to know whether use of a PDA alongside evidence-based information provided through the McMaster Optimal Aging Portal, or simply access to evidence-based information alone, can help users to make informed decisions about breast cancer screening in women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking women, 40-49 years old\n* Residents of British Columbia, Nova Scotia, and Prince Edward Island\n\nExclusion Criteria:\n\n* History of breast cancer or mammography in the last 12 months\n* Classified as above-average risk for breast cancer (i.e., known genetic mutation linked to BC; no genetic testing, but a parent, sibling or child with a genetic mutation linked to BC; or received chest wall radiation before age 30)'}, 'identificationModule': {'nctId': 'NCT03631758', 'briefTitle': 'Evaluating the Impact of Evidence-based Information About Mammography on Breast Cancer Screening Decisions', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'McMaster Choices Study: Evaluating the Impact of Cancer Screening Patient Decision Aids on Breast Cancer Screening Decisions', 'orgStudyIdInfo': {'id': '4352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Evidence + PDA', 'description': 'Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources), plus a blog post on PDAs and the relevant decision aid from the Portal database', 'interventionNames': ['Other: Evidence-based information', 'Behavioral: Patient Decision Aid']}, {'type': 'EXPERIMENTAL', 'label': 'Evidence only', 'description': 'The same evidence-based information as group 1 (Evidence + PDA), but without the PDA to quantify the effect of accessing evidence through the Portal alone', 'interventionNames': ['Other: Evidence-based information']}, {'type': 'SHAM_COMPARATOR', 'label': 'Attention control', 'description': 'Information on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs', 'interventionNames': ['Other: Sham information']}], 'interventions': [{'name': 'Evidence-based information', 'type': 'OTHER', 'description': 'Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).', 'armGroupLabels': ['Evidence only', 'Experimental: Evidence + PDA']}, {'name': 'Patient Decision Aid', 'type': 'BEHAVIORAL', 'description': 'Patient Decision Aid for breast cancer screening decision', 'armGroupLabels': ['Experimental: Evidence + PDA']}, {'name': 'Sham information', 'type': 'OTHER', 'description': 'Educational information not specific to mammography or cancer screening', 'armGroupLabels': ['Attention control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8P0A1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Maureen Dobbins, RN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Cancer Society (CCS)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}