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)

NCT ID: NCT05880420

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2021-08-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1 - home group

Group Type EXPERIMENTAL

Caregiver operations with medication accessories

Intervention Type DEVICE

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

Arm 2 - outpatient calibration

Group Type ACTIVE_COMPARATOR

Nurse operations with medication accessories

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Caregiver operations with medication accessories

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

Intervention Type DEVICE

Nurse operations with medication accessories

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

NETWORK

Sponsor Role collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38921720 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RS1518/21

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of Accuvein in Adult Patients
NCT01020461 TERMINATED PHASE4