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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive monitoring | Experimental | Intensive phone monitoring of drug adverse events |
|
| Standard monitoring | Placebo Comparator | Standard monitoring of drug adverse events |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive monitoring | Other | periodic and planned monitoring nurse intervention with phone call |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in treatment dose intensity | Changes intreatment dose intensity (Dose intensity) | 6 months |
Inclusion Criteria:
Patients aged >18;
Solid cancer histological diagnosis on treatment with one of the listed medicines, defined by treatment type:
Adjuvant chemotherapy:
First line oral target therapy:
Immunotherapy:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Bossi, MD | Italian Network of Supportive Care in Cancer | Study Chair |
| Andrea Antonuzzo, MD | Italian Network of Supportive Care in Cancer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2020 | Oct 19, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Two comparison groups: an intervention group (intensive phone monitoring of adverse event reactions) compared with a placebo group (standard monitoring)
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| Standard monitoring | Other | standard monitoring of adverse event reaction |
|
| 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 |