Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-06-22 @ 9:28 PM
Study NCT ID:
NCT03612934
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2018-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of SPC on Advanced Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-01-17', 'releaseDate': '2018-08-02'}], 'estimatedResultsFirstSubmitDate': '2018-08-02'}}, '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': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-26', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of intensification of patients negative symptoms before and after SPC', 'timeFrame': '14 days', 'description': 'intensification of patients negative symptoms was assessed by Edmonton Symptom Assessment System (esas)'}, {'measure': 'Variation of performance status of patients before and after SPC', 'timeFrame': '14 days', 'description': 'performance status of patients was assessed by ECOG scale (Eastern Cooperative Oncology Group)'}, {'measure': 'Variation of quality of life of patients before and after SPC', 'timeFrame': '14 days', 'description': 'quality of life of patients of patients was assessed by quality of life uniscale (QoLU)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'palliative care', 'life quality', 'performance status', 'esas'], 'conditions': ['Breast Cancer', 'Palliative Care', 'Quality of Life', 'Cancer, Breast']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, observational study is the evaluation of the effectiveness of a 14-day Specialist Palliative Care therapy in participants with advanced breast cancer carried out in a stationary palliative care unit in Poland. The length of the entire study will be 36 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '91 Years', 'minimumAge': '33 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced stage breast cancer refered for a SPC treatment at palliative care department in Poland, Będzin.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nthe patient's conscious consent for examination and the ability to fill in the form by the patient herself.\n\n\\-\n\nExclusion Criteria:\n\n* patients with cognitive disturbances disabling credible answers in the questionnaire, deceased patients or those discharged from the ward before 14 days of hospitalisation."}, 'identificationModule': {'nctId': 'NCT03612934', 'briefTitle': 'The Impact of SPC on Advanced Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Silesian University of Medicine'}, 'officialTitle': 'The Influence of Specialist Palliative Care on the Exacerbation of Negative Symptoms, Life Quality and Performance Status of Patients With Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'SPC1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients under the age of 65 years', 'description': 'patients under the age of 65 years', 'interventionNames': ['Procedure: Specialist Palliative Care']}, {'label': 'patients at the age of 65 years and over', 'description': 'patients at the age of 65 years and over', 'interventionNames': ['Procedure: Specialist Palliative Care']}], 'interventions': [{'name': 'Specialist Palliative Care', 'type': 'PROCEDURE', 'description': 'In the research, Specialist Palliative Care was provided according to the guidelines established by Mid-Western Health Board in a Report of the National Advisory Committee on Palliative Care as well as according to recommendations of Polish Society of Palliative Medicine and Polish National Healthcare Fund. In order to ensure interdisciplinary and integrated palliative care, a team of specialists was appointed. Team members were engaged in the process of treatment of each patient during the time of the study and applied their specialist skills according to the needs of the patients', 'armGroupLabels': ['patients at the age of 65 years and over', 'patients under the age of 65 years']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jadwiga Jośko-Ochojska, prof', 'role': 'STUDY_CHAIR', 'affiliation': '4. Chair and Department of Medicine and Environmental Epidemiology Medical University of Silesia in Katowice'}, {'name': 'Łukasz Pietrzyńsi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '1. Medical University of Silesia, department of palliative medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silesian University of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Łukasz Pietrzyński', 'investigatorAffiliation': 'Silesian University of Medicine'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-08-02', 'type': 'RELEASE'}, {'date': '2019-01-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Łukasz Pietrzyński, Principal Investigator, Silesian University of Medicine'}}}}