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)
ARCO
1 other identifier
interventional
27
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2021
CompletedFirst Submitted
Initial submission to the registry
March 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 30, 2023
CompletedJune 18, 2023
June 1, 2023
1 month
March 28, 2023
June 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Acceptability
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.
10 weeks
Study Arms (2)
Arm 1 - home group
EXPERIMENTALArm 2 - outpatient calibration
ACTIVE COMPARATORInterventions
After at least an initial outpatient medication (24/72 hours), home medication every 7 days (caregiver) for a total of 10 weeks.
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.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
"Regina Elena" National Cancer Institute
Rome, 00144, Italy
Related Publications (1)
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.
PMID: 38921720DERIVED
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2023
First Posted
May 30, 2023
Study Start
July 7, 2021
Primary Completion
August 16, 2021
Study Completion
August 16, 2021
Last Updated
June 18, 2023
Record last verified: 2023-06