The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Quality of life of patients during treatment
研究概览
简要总结
The study stems from the need to detect adverse events arising after the administration of Antibody-Drug Conjugates (ADCs) used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients.
详细描述
The study stems from the need to detect adverse events arising after the administration of ADCs used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients.Through the findings of toxicities related to the ADCs, it will be possible to highlight which are the issues that most affect patients undergoing these cancer treatments. The analysis of the data collected will also make it possible to highlight any toxicities not yet considered or/and of new onset. In addition useful elements may emerge from responses to the quality of life questionnaire, to cope with the difficulties expressed by patients regarding daily life activities, social relations, work and family. Such contributions will be fundamental to the construction of integrated care pathways, the aim of which is to involve a specialized nurse as part of a multidisciplinary team.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender;
- •Age ≥ 18 years;
- •Signature of consent to participate in the study and to the processing of personal data (Privacy);
- •Diagnosis of stage IV breast cancer;
- •Systemic treatment with T-DM1, T-DXD or SG as monotherapy;
- •Absence of cognitive decline, expressed by a score greater than or equal to 4 on the Six Item Screener questionnaire;
- •Good understanding of the Italian language;
- •Willingness and ability to adhere to scheduled visits, treatment plan, laboratory tests and study procedures.
排除标准
- •All patients who do not meet the above criteria will be excluded from the study.
结局指标
主要结局
Quality of life of patients during treatment
时间窗: up to 1 year
To assess the quality of life of patients treated with TDM-1, T-DXd, and SG through the administration of the EORTC QLQ-C30 questionnaire. Results will be reported as median and quartiles
Adverse events (AEs) arising during treatment and degree of toxicity
时间窗: up to 1 year
description of degree of toxicity of AEs classified using the international classification system CTCAE (version 5.0)
次要结局
- Treatment discontinuation(up to 1 year)
- Dose-reduction(up to 1 year)
- AEs - level of distress(up to 1 year)
- To describe the actions taken to manage treatment-related AEs(up to 1 year)
- Analyze the level of concordance between the AEs detected by health care personnel and the patient's subjective assessment(up to 1 year)
- Sources of distress(up to 1 year)