Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-14 @ 6:19 AM
Study NCT ID:
NCT03304002
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2017-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of a Web-based Decision Aid for Breast Cancer Surgery
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-23', 'studyFirstSubmitDate': '2017-09-27', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reach: Proportion of Participants who Utilize the Decision Aid', 'timeFrame': 'measured over the 4 month implementation period', 'description': 'Reach of the implementation is defined as the proportion of participants over the four month implementation period who: 1) are sent the decision aid and 2) access the decision aid.'}], 'secondaryOutcomes': [{'measure': 'Acceptability: Percentage of Participants Who Would Recommend Receiving Breast Cancer Information Via Email', 'timeFrame': 'Survey sent within 4 weeks of surgical consultation', 'description': 'acceptability will be defined as \\>80% of patients reporting they would recommend receiving breast cancer information via email to others.'}, {'measure': 'Barriers and Facilitators to Implementation of the Decision Aid', 'timeFrame': 'Interviewed completed within 6 months of the surgical consultation', 'description': 'One-on-one interviews with participants to identify those who experienced barriers and facilitators to implementing the decision aid'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Surgery']}, 'descriptionModule': {'briefSummary': "Routine incorporation of decision aids into oncology practice has the potential to significantly improve patients' experiences with cancer by increasing the likelihood that they make informed treatment decisions aligned with their values. Unfortunately, only a minority of the more than 1.6 million patients diagnosed annually with cancer ever receive one due to limited clinic resources for administration and challenges in timely identification of appropriate patients. Online delivery directly to patients addresses some of these barriers but is insufficient on its own to ensure accessibility for patients at the time they most benefit from support.19 It is critical that active, multi-faceted implementation strategies that target barriers to the widespread use of web-based decision aids be identified, as these tools have the potential to significantly improve the quality of oncologic care.\n\nBased on strong preliminary work, the investigators have developed and piloted a package of implementation strategies that effectively overcomes barriers to delivery of a web-based breast cancer surgery decision aid in an academic and community clinic. Although the strategy was successful, patients were white and educated; further investigation is imperative in settings that provide care to underserved patients to ensure the intervention will mitigate, rather than worsen, existing disparities in breast cancer care. This is especially critical given that underserved patients may benefit most from shared decision-making interventions such as the one described. To study this, the investigators propose a pilot study within a clinic that serves a catchment area with a high proportion of African American, rural and low income patients. The investigators will iteratively assess and enhance our implementation package using concepts outlined in the Knowledge-to-Action Cycle, which emphasizes local context in balancing fidelity and flexibility. The specific aims are: 1) To identify patient and clinic level barriers to implementation of a web-based breast cancer surgery decision aid in a clinic that cares for underserved patients, and 2) To test and expand our current implementation package's ability to address barriers in a clinic that cares for underserved patients. The investigators will determine the reach of implementation and acceptability of this method of decision aid delivery to stakeholders."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a clinic-level intervention with two stakeholder groups: (1) clinical staff, clinic leadership, and surgeons involved in implementation, and (2) patients newly diagnosed with Stage 0-3 breast cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients:\n\nInclusion Criteria:\n\n* Patients newly diagnosed with Stage 0-3 breast cancer.\n\nExclusion Criteria:\n\n* None\n\nClinic Stakeholders:\n\nInclusion Criteria: clinical staff, clinic leadership, and surgeons involved in implementation Exclusion Criteria: none'}, 'identificationModule': {'nctId': 'NCT03304002', 'briefTitle': 'Implementation of a Web-based Decision Aid for Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Implementation of a Web-based Decision Aid for Breast Cancer Surgery: Adapting to the Needs of Diverse Settings', 'orgStudyIdInfo': {'id': '2017-0588'}, 'secondaryIdInfos': [{'id': 'A539740', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\SURGERY\\GEN SURG', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '5P30CA014520-43', 'link': 'https://reporter.nih.gov/quickSearch/5P30CA014520-43', 'type': 'NIH'}, {'id': 'UW16147', 'type': 'OTHER', 'domain': 'UWCCC'}, {'id': 'Protocol Version 3/15/2019', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Breast Cancer Surgery Decision Aid', 'type': 'OTHER', 'description': 'We use a standard decision aid collaboratively developed by Health Dialog and the Informed Medical Decisions Foundation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Health System', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Heather Neuman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}