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

NCT ID: NCT04726020

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 645 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2022-01-31

Brief 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.

Detailed 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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intensive monitoring

Intensive phone monitoring of drug adverse events

Group Type: EXPERIMENTAL

Intensive monitoring

Intervention Type: OTHER

periodic and planned monitoring nurse intervention with phone call

Standard monitoring

Standard monitoring of drug adverse events

Group Type: PLACEBO_COMPARATOR

Standard monitoring

Intervention Type: OTHER

standard monitoring of adverse event reaction

Interventions

Intensive monitoring

periodic and planned monitoring nurse intervention with phone call

Intervention Type: OTHER

Standard monitoring

standard monitoring of adverse event reaction

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged >18;
• Solid cancer histological diagnosis on treatment with one of the listed medicines, defined by treatment type:

• Adjuvant chemotherapy:

• anthracyclines and cyclophosphamide ± taxanes (breast cancer)
• oxaliplatin e fluoropyrimidine (colon cancer)
• combination of platin or its derivate (lung cancer)
• First line oral target therapy:

• sunitinib, pazopanib (renal cancer)
• gefitinib, erlotinib,afatinib, crizotinib (lung cancer)
• vemurafenib ± comimetinib, dabrafenib±trametinib (Melanoma)
• everolimus ± exemestane (breast cancer)
• vandetanib o lenvatinib (thyroid cancer)
• vismodegib (skin basal cell carcinoma)
• imatinib (GIST)
• Immunotherapy:

• drugs anti CTLA4
• drugs antiPD1/PDL-1
• their combination
• sign of informed consent form;
• phone call availability and accessibility;
• life expectancy higher than 6 months.

Exclusion Criteria

• Presence of cerebral symptomatic metastasis;
• Presence of neurological or psychiatric disease or other conditions that stop the protocol procedure compliance;
• Participation in other clinical studies

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Bossi, MD

Role: STUDY_CHAIR

Italian Network of Supportive Care in Cancer

Andrea Antonuzzo, MD

Role: STUDY_CHAIR

Italian Network of Supportive Care in Cancer

Locations

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

NICSO

Identifier Type: -

Identifier Source: org_study_id