Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-06 @ 9:36 AM
Study NCT ID:
NCT06416293
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Widening Aims and Giving Patients a Voice for Expanded Structures in Breast Cancer Care Jointly Developed by Patients and Physicians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003142', 'term': 'Communication'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-05-10', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Current state of care - patient view', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'The primary aim of the questionnaire is to record the current reality of care for breast cancer patients with a focus on communication.'}], 'secondaryOutcomes': [{'measure': 'Current state of care - physician view', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Secondarily, a comparison will be made with the physicians assessment of the same topics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Communication', 'patient-physician-relationship', 'questionnaire'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this BZKF project is to record the current care structure for breast cancer patients in order to use this as a basis for developing possible future models for improvement. The active involvement of representatives of regional and national patient organizations in the creation of a patient-based and patient-oriented survey ensures that the needs of patients are the focus. In addition to and in contrast to other projects, relevant questions are explicitly addressed not only to patients but also to physicians in order to identify and specify the interfaces between patient wishes/suggestions and to develop clinical consequences for care.\n\nThe first objective is to survey the "current situation" by recording the current care structure for breast cancer. The focus is on the survey of both groups on patient-physician communication, time management and coping strategies.\n\nBy planning the future harmonization of national data structures, the basis is created for the long-term goal of an improved "target", a concept developed jointly by physicians and patients for an improved communication and care structure that focuses on the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women and men aged 18 years and older with breast cancer. Physicians treating breast cancer patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (patients):\n\n* Breast cancer or DCIS\n* women and men aged 18 years and older\n\nExclusion Criteria (patients):\n\n* women and men \\< 18 years\n* no histologically confirmed breast cancer or DCIS diagnosis\n\nInclusion Criteria (physicians):\n\n\\- Treatment of breast cancer patients'}, 'identificationModule': {'nctId': 'NCT06416293', 'acronym': 'WAVES', 'briefTitle': 'Widening Aims and Giving Patients a Voice for Expanded Structures in Breast Cancer Care Jointly Developed by Patients and Physicians', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Augsburg'}, 'officialTitle': 'Widening Aims and Giving Patients a Voice for Expanded Structures in Breast Cancer Care Jointly Developed by Patients and Physicians (Wechselseitiger Patienten-Arzt-Austausch in Der Versorgung Bei Brustkrebs Mit Dem Ziel Der Gemeinsamen Erarbeitung Neuer Patienten-orientierter Strukturen)', 'orgStudyIdInfo': {'id': '2.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BC Patients', 'description': 'Patients with diagnosis of breast cancer or DCIS', 'interventionNames': ['Other: Questionnaire patients']}, {'label': 'Physicians', 'description': 'Physicians treating patients with breast cancer', 'interventionNames': ['Other: Questionnaire physicians']}], 'interventions': [{'name': 'Questionnaire patients', 'type': 'OTHER', 'description': 'Completion of a two-part questionnaire with a special focus on communication around the breast cancer diagnosis. Tumor stage and therapies received are also surveyed. The questionnaire can be answered online via a secure tool (REDCap) or in paper form.', 'armGroupLabels': ['BC Patients']}, {'name': 'Questionnaire physicians', 'type': 'OTHER', 'description': 'Completion of a questionnaire with a special focus on communication around the breast cancer diagnosis', 'armGroupLabels': ['Physicians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86156', 'city': 'Augsburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nina Ditsch, Prof.', 'role': 'CONTACT', 'email': 'nina.ditsch@uk-agsburg.de', 'phone': '+49 821 400 165809'}, {'name': 'Melitta Köpke, Dr.', 'role': 'CONTACT', 'email': 'melitta.koepke@uk-augsburg.de', 'phone': '+49 821 400 165862'}], 'facility': 'University Hospital Augsburg, Department of Gynecology and Obstetrics', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}], 'centralContacts': [{'name': 'Nina Ditsch, Prof.', 'role': 'CONTACT', 'email': 'nina.ditsch@uk-augsburg.de', 'phone': '+49 821 400 15809'}, {'name': 'Melitta Köpke, Dr.', 'role': 'CONTACT', 'email': 'melitta.koepke@uk-augsburg.de', 'phone': '+49 821 400 165862'}], 'overallOfficials': [{'name': 'Nina Ditsch, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Augsburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Augsburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, {'name': 'Technical University of Munich', 'class': 'OTHER'}, {'name': 'LMU Klinikum', 'class': 'OTHER'}, {'name': 'University Hospital Regensburg', 'class': 'OTHER'}, {'name': 'University Hospital Erlangen', 'class': 'OTHER'}, {'name': 'Bavarian Cancer Research Center (BZKF)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Breast Centre University Hospital Augsburg, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Nina Ditsch', 'investigatorAffiliation': 'University Hospital Augsburg'}}}}