Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2026-02-24 @ 3:32 PM
Study NCT ID:
NCT05880420
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2023-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE)TELEHEALTH HOME MEDICATION VS/OUTPATIENT MEDICATION OF CENTRAL VENOUS CATHETER PICC (PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2023-03-28', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability', 'timeFrame': '10 weeks', 'description': 'To compare the incidence of complications found in peripherally inserted central venous catheter (PICC) management in outpatient (calibration arm) vs home management to test the hypothesis that the incidence of catheter-related complications in the home management group is not higher than that observed in the outpatient group.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infections']}, 'referencesModule': {'references': [{'pmid': '38921720', 'type': 'DERIVED', 'citation': 'Basili P, Farina I, Terrenato I, Centini J, Volpe N, Rizzo V, Agoglia L, Paterniani A, Aprea P, Calignano P, Petrone F, Ciliberto G. Remote Assisted Home Dressing vs. Outpatient Medication of Central Venous Catheter (Peripherally Inserted Central Venous Catheter): Clinical Trial A.R.C.O. (Remote Assistance Oncology Caregiver). Nurs Rep. 2024 Jun 11;14(2):1468-1476. doi: 10.3390/nursrep14020110.'}]}, 'descriptionModule': {'briefSummary': "Cancer patients need central venous access according to the different types of chemotherapy and support drugs for their treatment path. The presence of a central vascular access brings mechanical issues, thrombotic and infectious complications that can undermine the patient's health and the life of the catheter, therefore the management of venous accesses is clinically relevant. The prevention of infections remains mainly based on correct hand washing and compliance with aseptic techniques. This is a multicenter intervention study is composed by a single experimental arm (home) and a calibration arm (outpatient). The study is designed to evaluate that the complication rate recorded in the two groups are similar."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* Share patient choice\n* availability at the patient's home at least once a week\n* availability during on line appointment time with the tutor/video"}, 'identificationModule': {'nctId': 'NCT05880420', 'acronym': 'ARCO', 'briefTitle': 'EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE)TELEHEALTH HOME MEDICATION VS/OUTPATIENT MEDICATION OF CENTRAL VENOUS CATHETER PICC (PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER)', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE) TELEASSISTED HOME DRESSING VS/ OUTPATIENT DRESSING OF PICC CENTRAL VENOUS CATHETER (PERIPHERAL INSERTION CENTRAL VENOUS CATHETER)', 'orgStudyIdInfo': {'id': 'RS1518/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 - home group', 'interventionNames': ['Device: Caregiver operations with medication accessories']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 - outpatient calibration', 'interventionNames': ['Device: Nurse operations with medication accessories']}], 'interventions': [{'name': 'Caregiver operations with medication accessories', 'type': 'DEVICE', 'description': 'After at least an initial outpatient medication (24/72 hours), home medication every 7 days (caregiver) for a total of 10 weeks.', 'armGroupLabels': ['Arm 1 - home group']}, {'name': 'Nurse operations with medication accessories', 'type': 'DEVICE', 'description': 'Outpatient medication every week (for a total of 10 weeks). Patients adhering to this arm will be followed at the IGAV nursing clinic of the IFOs.', 'armGroupLabels': ['Arm 2 - outpatient calibration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': '"Regina Elena" National Cancer Institute', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}