Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT05965206
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2023-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation of a Pharmacist-Based, Post-Chemotherapy Follow-up Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2023-07-20', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital admission related to chemotherapy within 30-day post treatment', 'timeFrame': '30 days after receiving the first intravenous chemotherapy', 'description': 'Number of hospital admission related to chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacist', 'Follow up clinic'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '28506976', 'type': 'BACKGROUND', 'citation': 'Patel SD, Nguyen PAA, Bachler M, Atkinson B. Implementation of postdischarge follow-up telephone calls at a comprehensive cancer center. Am J Health Syst Pharm. 2017 Jun 1;74(11 Supplement 2):S42-S46. doi: 10.2146/ajhp160805.'}, {'pmid': '30065061', 'type': 'BACKGROUND', 'citation': 'Nguyen PAA, Enwere E, Gautreaux S, Lin H, Tverdek F, Lu M, Cao H, Chase J, Roux R. Impact of a pharmacy-driven transitions-of-care program on postdischarge healthcare utilization at a national comprehensive cancer center. Am J Health Syst Pharm. 2018 Sep 15;75(18):1386-1393. doi: 10.2146/ajhp170747. Epub 2018 Jul 31.'}, {'pmid': '35164607', 'type': 'RESULT', 'citation': 'Cebollero J, LaFollette JA, Walton SM, Adams Curry M. Evaluation of a Pharmacist-Developed, Nurse-Driven Protocol for Management of Parenteral Anticancer Therapy Infusion Reactions in an Ambulatory Infusion Center. J Oncol Pharm Pract. 2023 Jun;29(4):802-809. doi: 10.1177/10781552221079855. Epub 2022 Feb 14.'}, {'pmid': '31868004', 'type': 'RESULT', 'citation': 'Crannage AJ, Hennessey EK, Challen LM, Stevens AM, Berry TM. Implementation of a Discharge Education Program to Improve Transitions of Care for Patients at High Risk of Medication Errors. Ann Pharmacother. 2020 Jun;54(6):561-566. doi: 10.1177/1060028019896377. Epub 2019 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the impact of pharmacists on reducing chemotherapy-related side effects by providing education before and after patients receive intravenous chemotherapy at one of Cedars-Sinai outpatient infusion centers.\n\nParticipants will be interviewed via telephone within 7 business days after receiving intravenous chemotherapy from the outpatient cancer center infusion clinic.', 'detailedDescription': 'The study involves participation at a single timepoint only.\n\nParticipants who consented to participate and are considered eligible will be interviewed by a pharmacist via phone at approximately 7 business days after receiving intravenous chemotherapy infusion. Phone call will be made between the hours of 9am - 6pm on Monday - Saturday. Calls are anticipated to last between 15 to 20 minutes. Participants will be asked if they have experienced any adverse events since the infusion, whether or not they have had any barriers taking supportive care medications, and if the patient understands how to manage potential adverse events. If applicable, participants will be provided further education on optimizing adverse events, guided on proper medication administration times, and will be provided with non-pharmacological clinical pearls to minimize chemotherapy-related side effects and optimize supportive care management.\n\nIf unable to reach the participant or caregiver after three attempts, the participant will be considered ineligible. Participants can decline participation at any time during the phone call.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult cancer patients who initiated treatment with intravenous chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old\n* Diagnosed with cancer and is receiving treatment with intravenous chemotherapy\n* Treatment initiated at Cedars-Sinai Cancer Samuel Oschin Cancer Center (SOCC) or Cedars-Sinai Cancer Beverly Hills (CSCBH)\n* English-speaking or lives with English-speaking person\n* Access to a working phone\n\nExclusion Criteria:\n\n* Received follow-up calls through other specialty pharmacy program\n* History of infusion related reactions\n* Declined participation on follow-up interview\n* Age less than 18 years old\n* Non-English speaking\n* Electronic health record flagged for research opt out'}, 'identificationModule': {'nctId': 'NCT05965206', 'briefTitle': 'Implementation of a Pharmacist-Based, Post-Chemotherapy Follow-up Clinic', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Implementation of a Pharmacist-Based, Post-Chemotherapy Follow-up Clinic', 'orgStudyIdInfo': {'id': 'Study00002683'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention group', 'description': 'Participants receive a follow-up phone call from a pharmacist approximately 7 business days after receiving intravenous chemotherapy infusion', 'interventionNames': ['Behavioral: Follow-up phone interview']}, {'label': 'Control group', 'description': 'Participants do not receive a follow-up phone call from a pharmacist after receiving intravenous chemotherapy infusion'}], 'interventions': [{'name': 'Follow-up phone interview', 'type': 'BEHAVIORAL', 'otherNames': ['Follow-up call'], 'description': 'Follow-up phone interview within 7 business days after receiving intravenous chemotherapy', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Suwicha Limvorasak, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PharmD', 'investigatorFullName': 'Suwicha Limvorasak', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}