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)

Not Applicable

Completed

• Conditions: Infections
• Interventions: Device: Caregiver operations with medication accessories; Device: Nurse operations with medication accessories

• Registration Number: NCT05880420
• Lead Sponsor: Regina Elena Cancer Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-07
• Primary Completion: 2021-08-16
• Study Completion: 2021-08-16
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 - home group	Caregiver operations with medication accessories	-
Arm 2 - outpatient calibration	Nurse operations with medication accessories	-

Primary Outcome Measures

Name	Time	Method
Acceptability	10 weeks	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.

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy