Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT06566560
Status:
RECRUITING
Last Update Posted:
2024-08-22
First Post:
2024-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ROAD 2.0 to Sustainable Medication Use: Redispensing Unused Oral Anticancer Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2024-08-06', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The environmental impact of redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.', 'timeFrame': 'From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months', 'description': 'Environmental impact will be measured in CO2-eq'}, {'measure': 'Cost-savings obtained by redispensing unused oral anticancer drugs of verified quality compared to standard practice of disposal.', 'timeFrame': 'From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months.', 'description': 'Cost savings will be measured in euros'}], 'secondaryOutcomes': [{'measure': 'The proportion of usability of returned medication for redispensing and the reasons for quality disapproval.', 'timeFrame': 'From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months'}, {'measure': 'The proportion of returned unused oral anticancer drugs and reasons thereof.', 'timeFrame': 'From date of first dispensing unit the date of last unused medication package returning to the pharmacy, assessed up to 16 months'}, {'measure': "Patients' reasons for not wanting to participate in a redispensing program for oral anticancer drugs.", 'timeFrame': 'From date of first invitation to participate in the study until the end of the recruitment period, up to 8 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Oncology', 'Pharmacy', 'Drug Prescriptions']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective intervention study is to investigate the effectiveness of redispensing unused oral anticancer drugs.\n\nThe main questions it aims to answer are:\n\n* What are the cost-savings of redispensing unused oral anticancer drugs?\n* What is the environmental impact of redispensing unused oral anticancer drugs?\n\nResearchers will compare redispensing unused oral anticancer drugs to the standard practice of disposal.\n\nParticipants will receive their oral anticancer drugs in a sealed bag with a temperature indicator if needed. They will be asked to return any unused oral anticancer drugs to the pharmacy during their next visit to the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of all ages\n* A clinical diagnosis of cancer using an oral anticancer drug that requires storage at room temperature according to the Summary of Product Characteristics (SmPC).\n\nExclusion Criteria:\n\n* Patients that do not understand the Dutch or English language, in written or spoken.\n* Patients receiving prescriptions that contain an amount of tablets that deviates from the regular package size, resulting in the pharmacy dispensing an opened package'}, 'identificationModule': {'nctId': 'NCT06566560', 'briefTitle': 'The ROAD 2.0 to Sustainable Medication Use: Redispensing Unused Oral Anticancer Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Cost-savings and Environmental Impact Obtained From Redispensing Unused Oral Anticancer Drugs', 'orgStudyIdInfo': {'id': '2020-7049'}, 'secondaryIdInfos': [{'id': '111109', 'type': 'OTHER', 'domain': 'PaNaMa'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'interventionNames': ['Other: redispensing oral anticancer drugs']}], 'interventions': [{'name': 'redispensing oral anticancer drugs', 'type': 'OTHER', 'description': "Participants will receive oral anticancer drugs according to their regular prescriptions, distributed in the original manufacturer's package. Following the guideline, some oral anticancer drug (i.e. requiring temperature storage up to 25C degrees) will be supplemented with a validated temperature indicator (Timestrip Neo, customer configuration), enclosed with a seal bag. Patients are requested to return unused oral anticancer drugs to the outpatient pharmacy that distributed them.\n\nPharmacy staff will assess the quality of returned oral anticancer drugs, applying the following criteria:\n\n1. the seal bag is unopened\n2. the drug package is unopend and undamaged\n3. the expiry date is ≥ 3 months\n4. the medication has not been stored outside the product label storage claim\n\nOral anticancer drugs that meet all criteria are restocked, and consecutively redispensed to participants visiting the same outpatient pharmacy.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525 GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Shirley Xie', 'role': 'CONTACT', 'email': 'Shirley.Xie@radboudumc.nl', 'phone': '0611469114'}], 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'Shirley Xie', 'role': 'CONTACT', 'email': 'Shirley.Xie@radboudumc.nl', 'phone': '0611469114'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}