CancerNCT04726020
NICSO National Study: Physician - Nurse Monitoring Project About Oncological Adverse Events
A study testing Intensive monitoring and Standard monitoring in people with Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Intensive monitoring and Standard monitoring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 645 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 21Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Intensive monitoring, Standard monitoring
- Keywords
- immunotherapy, targeted therapy, chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive monitoringOther
periodic and planned monitoring nurse intervention with phone call
Standard monitoringOther
standard monitoring of adverse event reaction
| Study group | Role | What they receive |
|---|---|---|
| Intensive monitoring | Experimental | Intensive phone monitoring of drug adverse events Receives: Other: Intensive monitoring |
| Standard monitoring | Placebo comparator | Standard monitoring of drug adverse events Receives: Other: Standard monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
low grade toxicity (grade 1 and 2) incidence and duration
incidence and duration of grade 1 and 2 toxicity
Measured: 6 months
number of ER admissions and number of non-planned medical examinations
number of ER admissions and number of non-planned medical examinations
Measured: 6 months
number of hospitalization and its duration because of treatment toxicity
number of hospitalization and its duration because of treatment toxicity
Measured: 6 months
QoL (Quality of Life) assessment
administration of validated questionnaires and evaluation of patients'quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Mar 2018
- Primary completion1 Sep 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two comparison groups: an intervention group (intensive phone monitoring of adverse event reactions) compared with a placebo group (standard monitoring)
- Masking
- None (open label)
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Paolo Bossi, MD, Study chair, Italian Network of Supportive Care in CancerAndrea Antonuzzo, MD, Study chair, Italian Network of Supportive Care in Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726020
- Sponsor's protocol ID
- NICSO
- Status last verified
- Aug 2022
- First submitted
- 8 Sep 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NICSO National Study: Physician - Nurse Monitoring Project About Oncological Adverse Events
- ClinicalTrials.gov ID
- NCT04726020
- Acronym / sponsor ID
- NICSO
- Conditions
- Cancer
- Keywords
- immunotherapy, targeted therapy, chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two comparison groups: an intervention group (intensive phone monitoring of adverse event reactions) compared with a placebo group (standard monitoring)
| Arm | Type | Receives |
|---|---|---|
| Intensive monitoring | Experimental | Other: Intensive monitoringIntensive phone monitoring of drug adverse events |
| Standard monitoring | Placebo comparator | Other: Standard monitoringStandard monitoring of drug adverse events |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients aged >18;
- Solid cancer histological diagnosis on treatment with one of the listed medicines, defined by treatment type:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive monitoringperiodic and planned monitoring nurse intervention with phone call | Other | Intensive monitoring |
| Standard monitoringstandard monitoring of adverse event reaction | Other | Standard monitoring |
Primary outcome
Assessment of the number of days that have passed with at least a toxicity grade >= 3
Time frame: 6 months
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.
4 secondary outcomes
low grade toxicity (grade 1 and 2) incidence and duration
Time frame: 6 months
number of ER admissions and number of non-planned medical examinations
Time frame: 6 months
number of hospitalization and its duration because of treatment toxicity
Time frame: 6 months
QoL (Quality of Life) assessment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Bossi, MD study chair
Italian Network of Supportive Care in Cancer
Andrea Antonuzzo, MD study chair
Italian Network of Supportive Care in Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive monitoring and Standard monitoring in people with Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the number of days that have passed with at least a toxicity grade >= 3 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.