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OpenTrials
Completed

NCT Number: NCT05880420

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)

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.

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Key information

Conditions

Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Share patient choice
  • availability at the patient's home at least once a week
  • availability during on line appointment time with the tutor/video

Treatment and study plan

Caregiver operations with medication accessories

Device

After at least an initial outpatient medication (24/72 hours), home medication every 7 days (caregiver) for a total of 10 weeks.

Nurse operations with medication accessories

Device

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.

Primary outcomes

  1. Acceptability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Collaborators

  • Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Registry information

Official study title

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)

Acronym: ARCO

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 30, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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