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NICSO National Study: Physician - Nurse Monitoring Project About Oncological Adverse Events

NCT04726020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2022-08-09

No results posted yet for this study

Summary

The lacking adherence to guidelines on prevention and treatment of different chemotherapy, targeted therapy, and immunotherapy induced toxicities is the reason why there are a potential incidence and duration increase of adverse events. It is clear the need of a collateral effect early recognition for an adequate clinical management and for limiting their intensity and duration.

There is the need for a multicentre randomized clinical study in specific therapeutical settings (chemotherapy, target therapy, immunotherapy) assessing the impact of planned and ongoing patients' monitoring by nurses.

The NICSO study foresees patient enrolment that is in adjuvant chemotherapy for breast cancer, colon, and lung; that is in chemotherapy or immunotherapy or with targeted therapy. Moreover, this working assesses toxicity differences (but also of QoL, number of PS access or non-planned medical examinations, number of hospitalization and number of recovery days) in patients that carried out a toxicity prevention and cure standard therapy in comparison with the standard assessment to which is added a periodic nursing phone intervention.

Conditions

Interventions

OTHER

Intensive monitoring

periodic and planned monitoring nurse intervention with phone call

OTHER

Standard monitoring

standard monitoring of adverse event reaction

Sponsors & Collaborators

Principal Investigators

  • Paolo Bossi, MD · Italian Network of Supportive Care in Cancer

  • Andrea Antonuzzo, MD · Italian Network of Supportive Care in Cancer

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2021-09-01
Completion
2022-01-31

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04726020 on ClinicalTrials.gov