Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-01 @ 3:06 PM
Study NCT ID:
NCT03116035
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2017-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001519', 'term': 'Behavior'}], '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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2016-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-08', 'studyFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2017-04-12', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge using the Breast Cancer Decision Quality Instrument', 'timeFrame': 'immediately prior to the surgical consultation'}], 'secondaryOutcomes': [{'measure': 'Decisional concordance using the Breast Cancer Decision Quality Instrument', 'timeFrame': 'immediately prior to the surgical consultation'}, {'measure': 'Perceived communication with the breast surgeon using the Breast Cancer Decision Quality Instrument', 'timeFrame': 'following the surgical consultation but prior to the surgery'}, {'measure': 'Breast surgeon and staff (nurse, mid-level provider) assessment of how the web-based decision aid versus standard high-quality breast cancer websites influenced their patient interactions, based on Practitioner Opinion Survey', 'timeFrame': 'at completion of patient accrual, estimated to be 2 years after initiating study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Knowledge, Attitudes, Practice']}, 'referencesModule': {'references': [{'pmid': '29246705', 'type': 'DERIVED', 'citation': "Tucholka JL, Yang DY, Bruce JG, Steffens NM, Schumacher JR, Greenberg CC, Wilke LG, Steiman J, Neuman HB. A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options. J Am Coll Surg. 2018 Feb;226(2):126-133. doi: 10.1016/j.jamcollsurg.2017.10.024. Epub 2017 Dec 12."}]}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized control trial to compare the impact of two different types of pre-operative web-based breast cancer information on the quality of patient decision making. Patients are emailed web-based information prior to the surgical consultation. Outcomes are assess at multiple time points: 1) prior to the surgical consultation, 2) immediately following the consultation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. \\>18 years of age\n2. Newly diagnosed stage 0-3 breast cancer\n3. English speaking\n4. Has an email address\n5. No prior recent contact with the breast surgeon'}, 'identificationModule': {'nctId': 'NCT03116035', 'briefTitle': 'Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'A Randomized Controlled Trial Evaluating the Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making', 'orgStudyIdInfo': {'id': '2013-1500'}, 'secondaryIdInfos': [{'id': 'UW13089', 'type': 'OTHER', 'domain': 'UWCCC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Web-based decision aid', 'description': 'A commercially available web-based breast cancer surgery decision aid', 'interventionNames': ['Other: Web-based decision aid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard websites', 'description': 'selected, high-quality standard web-sites', 'interventionNames': ['Other: Standard websites']}], 'interventions': [{'name': 'Web-based decision aid', 'type': 'OTHER', 'description': 'Patients were randomized to receive links to a commercially available decision aid.', 'armGroupLabels': ['Web-based decision aid']}, {'name': 'Standard websites', 'type': 'OTHER', 'description': 'Patients were randomized to receive links to standard, high-quality websites.', 'armGroupLabels': ['Standard websites']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}