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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Intensive monitoring; Other: Standard monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 645
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale Dei Tumori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;
• Previous systemic cancer treatment. These exclusion criteria are justified because usually a systemic cancer treatment cause changes in toxicity profile. This means that these patients have higher attention on their toxicities and probably receive codified preventive treatments already.
• Participation in other clinical studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive monitoring; Intensive phone monitoring of drug adverse events	Other: Intensive monitoring; periodic and planned monitoring nurse intervention with phone call
Placebo Comparator: Standard monitoring; Standard monitoring of drug adverse events	Other: Standard monitoring; standard monitoring of adverse event reaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the number of days that have passed with at least a toxicity grade >= 3	Assessment of the number of days that have passed with at least a toxicity grade >= 3. The assessed toxicities have been chosen for their clinical relevance and for their higher danger to reduce patients' treatment adherence, invalidating therapy benefits.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
low grade toxicity (grade 1 and 2) incidence and duration	incidence and duration of grade 1 and 2 toxicity	6 months
number of ER admissions and number of non-planned medical examinations	number of ER admissions and number of non-planned medical examinations	6 months
number of hospitalization and its duration because of treatment toxicity	number of hospitalization and its duration because of treatment toxicity	6 months
QoL (Quality of Life) assessment	administration of validated questionnaires and evaluation of patients'quality of life	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in treatment dose intensity	Changes intreatment dose intensity (Dose intensity)	6 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Chair: Paolo Bossi, MD, Italian Network of Supportive Care in Cancer; Study Chair: Andrea Antonuzzo, MD, Italian Network of Supportive Care in Cancer

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: chemotherapy; immunotherapy; targeted therapy
• Other Study ID Numbers: NICSO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No