Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-28 @ 11:50 PM
Study NCT ID:
NCT04741503
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ahousten@wustl.edu', 'phone': '314-454-7958', 'title': 'Ashley J. Housten, OTD, MSCI', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were followed through completion of questionnaires (day 1 - approximately 30 minutes)', 'eventGroups': [{'id': 'EG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 0, 'seriousNumAtRisk': 137, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 0, 'seriousNumAtRisk': 147, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Knowledge Score of Screening Mammography Guidelines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'title': 'Pre-questionnaire', 'categories': [{'measurements': [{'value': '51.0', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '47.0', 'spread': '26.4', 'groupId': 'OG001'}]}]}, {'title': 'Post-questionnaire', 'categories': [{'measurements': [{'value': '56.2', 'spread': '28.6', 'groupId': 'OG000'}, {'value': '54.6', 'spread': '29.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '* The total knowledge score will be collected by the Breast Cancer and Breast Cancer Screening Mammography knowledge questions.\n* This questionnaire was modified from an existing breast cancer screening knowledge from Hersch et al. This questionnaire covers mammography, screening benefits and downsides, and guidelines.\n* Six of the knowledge questions were scored as correct (1) or incorrect/unsure (0). The percentage of correct scores was calculated per participant pre-intervention and post-intervention (range, 0-100). A higher score indicates higher knowledge.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feelings of Being Fully Informed and Clear About the Importance of the Components for Making Informed Decisions as Measured by the Decisional Conflict Scale (DCS), Values Clarity Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.6', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '19.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-The 3-item Values Clarity Subscale (questions 4-6) uses a 5-point response format, ranging from 0 (yes) to 4 (no) to assess feelings of clarity about personal values for benefits and risks/side effects. Items are summed and scores are calculated on a range of 0 (feels extremely clear about personal values for benefits/risks) to 100 (feels extremely unclear about personal values). A higher score indicates less clarity on personal values.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '73.2', 'spread': '21.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-The 5-Point Decision Self-Efficacy Scale will be modified for breast cancer screening and will measure self-confidence or belief in one\'s decision-making abilities, including shared decision-making. Questions ask participants how confident they are in a variety of health related skills. This 11-item scale has five response options from "not at all confident" (0) to "extremely confident" (4). Items are summed and scores are calculated on a range of 0-100. A higher score indicates higher decisional self-efficacy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Preparation for Decision Making Scale as Measured by PrepDM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '68.5', 'spread': '27.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': "-The Preparation for Decision Making Scale (PrepDM) assesses a patient's perception of how useful a decision aid or educational materials are in making a screening or treatment decision. The 10-item scale uses a 5-point Likert response format, ranging from 0 (not at all) to 4 (a great deal). Items are summed and scores are calculated on a range of 0-100. Higher scores indicate higher perceived levels of preparation for decision making.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'title': 'Breast cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Poor', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Good', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}, {'title': 'Excellent', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Missing responses', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Breast cancer screening mammography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Poor', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Good', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}, {'title': 'Excellent', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}, {'title': 'Missing responses', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Guidelines for screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Poor', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Good', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}, {'title': 'Excellent', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Missing responses', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Benefits of screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Poor', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Good', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'title': 'Excellent', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}, {'title': 'Missing responses', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Downsides of screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Poor', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Good', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Excellent', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Missing responses', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Questions to help make the decision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Poor', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Good', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'title': 'Excellent', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Missing responses', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stories about other women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Poor', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Fair', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '67', 'groupId': 'OG000'}]}, {'title': 'Excellent', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Missing responses', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-Adapted acceptability measures from the Ottawa Acceptability Measures including questions eliciting ratings of the information presented in the tool. Each question will ask the participant to rate the information in the tool they viewed as poor, fair, good, or excellent to show what they thought about the way the information was presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Stories about other women question was only asked of the Breast Cancer Screening Decision Support Tool arm.'}, {'type': 'SECONDARY', 'title': 'Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'categories': [{'title': 'Too long', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Too short', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Just right', 'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the length of tool. The questionnaire asks the participant to rate the length of the tool they viewed as too long, too short, just right, or prefer not to answer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'title': 'Too much information', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Too little information', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Just right', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Prefer not to answer', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the amount of information in the tool. The questionnaire asks the participant to rate the amount of information as too much information, too little information, just right, or prefer not to answer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance", 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'title': 'Slanted towards screening', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Slanted towards NOT screening', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Balanced', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Prefer not to answer', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': "-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the balance of the tool's balance. The questionnaire asks the participant to rate the tool as slanted towards screening, slanted towards NOT screening, balanced, or prefer not to answer", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Prefer not to answer', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the usefulness of the tool for decision-making. The questionnaire asks the participant if they would find this decision tool useful when making decision for when to start screening mammography (yes, no, prefer not to answer).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'title': 'Easy', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Difficult', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Prefer not to answer', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': "-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the helpfulness for decision making of the breast cancer screening decision support tool's questions. The questionnaire asks the participant if the questions in the tool made decision making easier or more difficult or if they prefer not to answer.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This question was for participants enrolled in the Breast Cancer Screening Decision Support Tool arm only.'}, {'type': 'SECONDARY', 'title': 'Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Prefer not to answer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the amount of information in the tool for decision making. The questionnaire asks the participant if the tool provided enough information to help a woman decide when to start breast cancer screening mammography (yes, no, prefer not to answer).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intention to Screen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'OG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}], 'classes': [{'title': 'Pre-questionnaire', 'categories': [{'title': 'Leaning toward screening', 'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}, {'title': 'Leaning away from screening', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'Unsure or unknown (no response)', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Post-questionnaire', 'categories': [{'title': 'Leaning toward screening', 'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}, {'title': 'Leaning away from screening', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Unsure or unknown (no response)', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': "-This is the participants' intention to undergo breast cancer screening within the upcoming year. The questionnaire asks the participant how likely they are to have a screening mammography this upcoming year. Response options include: leaning toward screening (definitely will be tested or probably will be tested), leaning away from screening (probably won't be tested or definitely won't be tested), unsure, and prefer not to answer.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'FG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}, {'id': 'FG002', 'title': 'Participants Who Were Not Randomized', 'description': 'Participants who consented to participate in the study but were removed prior to randomization.'}], 'periods': [{'title': 'Initial Enrollment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '164'}, {'groupId': 'FG002', 'numSubjects': '953'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '164'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '953'}]}], 'dropWithdraws': [{'type': 'Failed to meet screening criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '767'}]}, {'type': 'Overquotas removed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '186'}]}]}, {'title': 'Met Protocol Criteria for Data Inclusion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '164'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '147'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Removed from study for not meeting protocol criteria for free responses to knowledge questions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '1277 participants consented to participate in the study. 767 participants were removed prior to randomization as they failed to meet screening criteria. 186 participants were removed prior to randomization as overquotas (i.e., having already met the targeted goals for race/ethnicity) were removed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.'}, {'id': 'BG001', 'title': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-01', 'size': 1075884, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-01T09:54', 'hasProtocol': True}, {'date': '2021-04-07', 'size': 143793, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-30T08:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2021-01-25', 'resultsFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-30', 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Knowledge Score of Screening Mammography Guidelines', 'timeFrame': 'In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '* The total knowledge score will be collected by the Breast Cancer and Breast Cancer Screening Mammography knowledge questions.\n* This questionnaire was modified from an existing breast cancer screening knowledge from Hersch et al. This questionnaire covers mammography, screening benefits and downsides, and guidelines.\n* Six of the knowledge questions were scored as correct (1) or incorrect/unsure (0). The percentage of correct scores was calculated per participant pre-intervention and post-intervention (range, 0-100). A higher score indicates higher knowledge.'}, {'measure': 'Feelings of Being Fully Informed and Clear About the Importance of the Components for Making Informed Decisions as Measured by the Decisional Conflict Scale (DCS), Values Clarity Subscale', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-The 3-item Values Clarity Subscale (questions 4-6) uses a 5-point response format, ranging from 0 (yes) to 4 (no) to assess feelings of clarity about personal values for benefits and risks/side effects. Items are summed and scores are calculated on a range of 0 (feels extremely clear about personal values for benefits/risks) to 100 (feels extremely unclear about personal values). A higher score indicates less clarity on personal values.'}, {'measure': 'Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-The 5-Point Decision Self-Efficacy Scale will be modified for breast cancer screening and will measure self-confidence or belief in one\'s decision-making abilities, including shared decision-making. Questions ask participants how confident they are in a variety of health related skills. This 11-item scale has five response options from "not at all confident" (0) to "extremely confident" (4). Items are summed and scores are calculated on a range of 0-100. A higher score indicates higher decisional self-efficacy.'}, {'measure': 'Preparation for Decision Making Scale as Measured by PrepDM', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': "-The Preparation for Decision Making Scale (PrepDM) assesses a patient's perception of how useful a decision aid or educational materials are in making a screening or treatment decision. The 10-item scale uses a 5-point Likert response format, ranging from 0 (not at all) to 4 (a great deal). Items are summed and scores are calculated on a range of 0-100. Higher scores indicate higher perceived levels of preparation for decision making."}], 'secondaryOutcomes': [{'measure': 'Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-Adapted acceptability measures from the Ottawa Acceptability Measures including questions eliciting ratings of the information presented in the tool. Each question will ask the participant to rate the information in the tool they viewed as poor, fair, good, or excellent to show what they thought about the way the information was presented.'}, {'measure': 'Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the length of tool. The questionnaire asks the participant to rate the length of the tool they viewed as too long, too short, just right, or prefer not to answer.'}, {'measure': 'Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the amount of information in the tool. The questionnaire asks the participant to rate the amount of information as too much information, too little information, just right, or prefer not to answer.'}, {'measure': "Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance", 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': "-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the balance of the tool's balance. The questionnaire asks the participant to rate the tool as slanted towards screening, slanted towards NOT screening, balanced, or prefer not to answer"}, {'measure': 'Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the usefulness of the tool for decision-making. The questionnaire asks the participant if they would find this decision tool useful when making decision for when to start screening mammography (yes, no, prefer not to answer).'}, {'measure': 'Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': "-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the helpfulness for decision making of the breast cancer screening decision support tool's questions. The questionnaire asks the participant if the questions in the tool made decision making easier or more difficult or if they prefer not to answer."}, {'measure': 'Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making', 'timeFrame': 'In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': '-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the amount of information in the tool for decision making. The questionnaire asks the participant if the tool provided enough information to help a woman decide when to start breast cancer screening mammography (yes, no, prefer not to answer).'}, {'measure': 'Intention to Screen', 'timeFrame': 'In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)', 'description': "-This is the participants' intention to undergo breast cancer screening within the upcoming year. The questionnaire asks the participant how likely they are to have a screening mammography this upcoming year. Response options include: leaning toward screening (definitely will be tested or probably will be tested), leaning away from screening (probably won't be tested or definitely won't be tested), unsure, and prefer not to answer."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Literacy', 'Health Disparities', 'Shared Decision Making'], 'conditions': ['Breast Cancer Screening', 'Oncology', 'Preventative Medicine', 'Mammography']}, 'referencesModule': {'references': [{'pmid': '38726892', 'type': 'DERIVED', 'citation': "Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2."}], 'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to conduct a feasibility study to evaluate the potential for implementing the developed decision support tool with Latina, Black, and non-Latina White women. The investigators will collect feasibility data and assess the use of the decision support tool with end-users. The aim is to determine if women using the decision support tool make more informed choices measured by knowledge, attitudes, and intentions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Latina, Black, or non-Latina White women\n* Between the ages of 40-49 years\n* Can write, read, and understand English\n\nExclusion Criteria:\n\n-Women with greater than an average self-reported risk of breast cancer will be ineligible for participation, as evidenced by any of the following:\n\n* Self-reported personal history of breast cancer (invasive, ductal carcinoma in situ \\[DCIS\\], or lobular carcinoma in situ\\[LCIS\\])\n* Self-reported personal history of atypical hyperplasia\n* Self-reported first degree family member with history of breast cancer (e.g., mother, sister)\n* Self-reported known underlying genetic mutation such as a BRCA1/BRCA2 gene\n* Self-reported prior thoracic or chest wall radiation therapy'}, 'identificationModule': {'nctId': 'NCT04741503', 'briefTitle': 'Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool', 'orgStudyIdInfo': {'id': '202101073'}, 'secondaryIdInfos': [{'id': '5R00MD011485-04', 'link': 'https://reporter.nih.gov/quickSearch/5R00MD011485-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breast Cancer Screening Decision Support Tool', 'description': '-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.', 'interventionNames': ['Other: Breast Cancer Screening Decision Support Tool']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Breast Cancer Screening Education', 'description': '-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.', 'interventionNames': ['Other: National Cancer Institute Breast Cancer Screening PDQ']}], 'interventions': [{'name': 'Breast Cancer Screening Decision Support Tool', 'type': 'OTHER', 'description': "-Provides a description of screening mammography, current screening recommendations, benefits and downsides, narratives, and questions for the participant's physician.", 'armGroupLabels': ['Breast Cancer Screening Decision Support Tool']}, {'name': 'National Cancer Institute Breast Cancer Screening PDQ', 'type': 'OTHER', 'description': '-Provides current information about breast cancer screening and is meant to inform and help patients', 'armGroupLabels': ['Standard Breast Cancer Screening Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Ashley J Housten, OTD, MSCI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Up to 36 months following publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after De-identified data may be shared upon reasonable request.', 'accessCriteria': 'Please contact the principal investigator with requests.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}