Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04726020 |
Other study ID # |
NICSO |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2018 |
Est. completion date |
January 31, 2022 |
Study information
Verified date |
August 2022 |
Source |
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
A better toxicity management can have a positive impact on a correct treatments
dose-intensity. Scientific community debate on toxicity assessment ways and means is still
open. The most debated questions concern:
- Physician and/or patient reporting adverse events;
- Nurse role in the adverse events assessment;
- How much assessment methods (assessment frequency, who's involved in adverse events
monitoring) means for:
- Time spent with toxicity and intensity reduction;
- Treatment adherence. Some literature evidence is avaiable and support the need of
intensive monitoring of patients in terms of adverse events. However, 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.
This is a multi-centric, randomized, open comparative study design, between a planned and
consecutive monitoring nurse intervention in addition to the chemotherapy toxicity prevention
and cure standard therapy package insert (chemotherapy, target therapy, immunotherapy), and
the only use of the cancer therapy toxicity prevention and cure standard therapy package
insert (chemotherapy, target therapy, immunotherapy).
The study involves All the patients with a solid tumor on treatment with adjuvant
chemotherapy or receiving target therapy or immunotherapy for the first time in their cancer
history.
This study design will last 24 months. Patient recruitment will last 18 months from the
beginning of the study. The study period will be 4 months for the group on treatment with
immunotherapy and target therapy and at least 6 months for the group on treatment with
adjuvant chemotherapy. The study could be interrupted when there is a therapy withdrawal
because of cancer progression, severe toxicity or for the informed consent for withdrawal, or
because of death. If there is a temporary interruption or a treatment withdrawal period,
patients still are in under monitoring, according to their group. The study will end with the
end of the planned period monitoring, which is the last call to the enlisted patients.