Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-29 @ 4:32 PM
Study NCT ID:
NCT02746666
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2016-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacist's Influence on Breast Cancer Patient Quality of Life
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2016-04-09', 'studyFirstSubmitQcDate': '2016-04-20', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "changes in quality of life of a breast cancer patient under chemotherapy, after a clinical pharmacist's behavioral intervention, measured by EORTC B23 questionnaire", 'timeFrame': 'up to two months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer, Quality of Life']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the impact of pharmacist behavioral intervention's influence on breast cancer patients' quality of life. Croatian randomized controlled trial. Targeted population: general population of breast cancer patients under the first adjuvant anthracycline chemotherapy. Primary outcome: difference in EORTC QLQ-BR23 questionnaire result from the baseline to after 3 week cycle."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Early breast cancer\n* First adjuvant chemotherapy\n* Chemotherapy protocol: anthracycline x 4\n\nExclusion Criteria:\n\n* Cardiovascular comorbidities\n* Regular nausea or vomiting during six months before enrollment\n* Unable to answer the quality of life questionnaire on their own'}, 'identificationModule': {'nctId': 'NCT02746666', 'acronym': 'PIBC', 'briefTitle': "Pharmacist's Influence on Breast Cancer Patient Quality of Life", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Sestre Milosrdnice'}, 'officialTitle': "Influence of a Clinical Pharmacist's Intervention on Quality of Life of a Breast Cancer Patient Under Adjuvant Chemotherapy", 'orgStudyIdInfo': {'id': '1705201504032016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "Under pharmacist's behavioral intervention", 'interventionNames': ["Behavioral: Pharmacist's behavioral intervention"]}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "No pharmacist's behavioral intervention"}], 'interventions': [{'name': "Pharmacist's behavioral intervention", 'type': 'BEHAVIORAL', 'description': "Pharmacist's 30 min counselling on antiemetic therapy, causes of nausea or vomiting and ways to prevent them during chemotherapy.", 'armGroupLabels': ['Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Sestre Milosrdnice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PHD', 'investigatorFullName': 'Robert Šeparović', 'investigatorAffiliation': 'University Hospital Sestre Milosrdnice'}}}}