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临床试验/NCT04726020
NCT04726020已完成不适用

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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano1 个研究点 分布在 1 个国家目标入组 645 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
645
试验地点
1
主要终点
Assessment of the number of days that have passed with at least a toxicity grade >= 3

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Intensive monitoring

Experimental

Intensive phone monitoring of drug adverse events

干预措施: Intensive monitoring (Other)

Standard monitoring

Placebo Comparator

Standard monitoring of drug adverse events

干预措施: Standard monitoring (Other)

结局指标

主要结局

Assessment of the number of days that have passed with at least a toxicity grade >= 3

时间窗: 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.

次要结局

  • low grade toxicity (grade 1 and 2) incidence and duration(6 months)
  • number of ER admissions and number of non-planned medical examinations(6 months)
  • number of hospitalization and its duration because of treatment toxicity(6 months)
  • QoL (Quality of Life) assessment(6 months)

研究者

发起方
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
申办方类型
Other
责任方
Sponsor

研究点 (1)

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