Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-29 @ 12:42 PM
Study NCT ID:
NCT06826950
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2025-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Pharmacy Services on Gynaecology Chemotherapy Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 629}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Chemotherapy-related adverse reactions', 'timeFrame': 'From enrollment to the end of treatment at 3 weeks'}], 'primaryOutcomes': [{'measure': 'Degree of myelosuppression', 'timeFrame': 'From enrollment to the end of treatment at 3 weeks'}], 'secondaryOutcomes': [{'measure': 'Degree of adverse gastrointestinal reactions', 'timeFrame': 'From enrollment to the end of treatment at 3 weeks'}, {'measure': 'Readmission rate', 'timeFrame': 'From enrollment to the end of treatment at 3 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmaceutical Services', 'Neoplasms', 'Chemotherapy', 'Gynaecological Oncology'], 'conditions': ['Neoplasms', 'Gynaecological Oncology']}, 'descriptionModule': {'briefSummary': "What was studied? We wanted to see whether having pharmacists closely involved in cancer care improves medication safety and reduces severe side effects for patients with gynecologic cancers (like ovarian or uterine cancer) during chemotherapy.\n\nHow was the study done?\n\nWho participated? Patients receiving chemotherapy at Peking University First Hospital's Gynecologic Oncology Ward (September 2022-September 2024).\n\nTwo groups compared:\n\nStandard care group: Pharmacists provided routine pharmaceutical services.\n\nFull pharmacy care group: Pharmacists provided ongoing support, including:\n\nChecking medications for safety.\n\nTeaching patients how to manage side effects.\n\nAnswering questions about drugs.\n\nHelping manage reactions like nausea or low white blood cells.\n\nWhat was measured? Severe side effects (e.g., extreme nausea, appetite loss), how well doctors prescribed and monitored medications to boost white blood cells, and unplanned hospital stays.\n\nKey findings:\n\nPatients with full pharmacy care had:\n\nFewer severe side effects: Less extreme nausea, appetite loss, and dangerously low white blood cell counts.\n\nBetter management of blood cell-boosting medications: Doctors followed guidelines more closely, and patients received proper monitoring.\n\nFewer unplanned hospital visits: Likely due to better side effect prevention and early intervention.\n\nWhy does this matter?\n\nFor patients: Pharmacist support during chemotherapy may help you avoid severe side effects and reduce unexpected hospital stays.\n\nFor families: Knowing pharmacists are actively involved can provide reassurance about your loved one's medication safety.\n\nFor healthcare teams: Structured pharmacist collaboration improves adherence to treatment guidelines and patient outcomes.\n\nTakeaway:\n\nFull pharmacy care throughout chemotherapy helps protect patients' safety, reduces severe reactions, and supports smoother treatment journeys."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with gynaecological tumours receiving chemotherapy at our hospital', 'genderDescription': "Ovarian cancer is a disease that occurs exclusively in individuals of the female biological sex (i.e., those who have ovaries). Therefore, eligibility to participate in research is typically based on \\*\\*biological sex\\*\\*, rather than \\*\\*gender identity\\*\\*. This means that even if a person's gender identity is not female (such as transgender men or non-binary individuals), they are still eligible to participate in ovarian cancer research as long as they have ovaries.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with gynaecologic malignancies such as ovarian cancer, cervical cancer, endometrial cancer, or gestational trophoblastic tumours.\n* Patients who received one of the following chemotherapy regimens: taxane monotherapy or combination therapy, anthracycline monotherapy or combination therapy, platinum-based monotherapy or combination therapy. These chemotherapy regimens could be combined with targeted therapy or immunotherapy.\n\nExclusion Criteria:\n\n* Patients treated with chemotherapy regimens outside those specified in the inclusion criteria.\n* Patients who received only targeted therapy, immunotherapy, endocrine therapy, bone-modifying therapy, or combinations of these treatments.'}, 'identificationModule': {'nctId': 'NCT06826950', 'briefTitle': 'Impact of Pharmacy Services on Gynaecology Chemotherapy Safety', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'The Impact of Comprehensive Pharmaceutical Services on Medication Safety in Gynaecological Oncology Chemotherapy Patients', 'orgStudyIdInfo': {'id': '2024Y511-002'}, 'secondaryIdInfos': [{'id': '2024SF58', 'type': 'OTHER_GRANT', 'domain': 'Peking University First Hospital, China'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'interventionNames': ['Other: Routine pharmaceutical services']}, {'label': 'Intervention group', 'interventionNames': ['Other: comprehensive pharmaceutical care']}], 'interventions': [{'name': 'comprehensive pharmaceutical care', 'type': 'OTHER', 'description': 'The intervention group received comprehensive pharmaceutical care in addition to standard care. For first-cycle patients, oncology pharmacists conducted patient education, informing them about potential chemotherapy-induced adverse reactions and corresponding management strategies. Patients were instructed on the proper use of antiemetic medications, the recommended frequency of blood routine tests, and the appropriate timing, dosing, and administration of granulocyte colony-stimulating factor (G-CSF) and thrombopoietic agents. A QR code for oncology pharmacist consultation was provided to enable patients to seek advice on medication-related issues encountered outside the hospital.', 'armGroupLabels': ['Intervention group']}, {'name': 'Routine pharmaceutical services', 'type': 'OTHER', 'description': 'The control group received standard care: After the doctor issues the chemotherapy order, the oncology pharmacist only reviews the order to ensure that the chemotherapy regimen and pretreatment regimen during the study are consistent with those of the experimental group. No other interventions are performed.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Hospital patient data needs to be kept confidential'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacist', 'investigatorFullName': 'Zhiqi Zhang', 'investigatorAffiliation': 'Peking University First Hospital'}}}}