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.
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.
Study Type
OBSERVATIONAL
Enrollment
92
Centro di Riferimento Oncologico (CRO)
Aviano, Pordenone, Italy
Fondazione IRCCS Istituto Nazionale dei tumori
Milan, Italy
Istituto Nazionale Tumori IRCCS G. Pascale
Naples, Italy
Adverse events (AEs) arising during treatment and degree of toxicity
Frequency adverse events (AEs) arising during treatment with TDM-1, T-DXd and SG
Time frame: up to 1 year
Adverse events (AEs) arising during treatment and degree of toxicity
description of degree of toxicity of AEs classified using the international classification system CTCAE (version 5.0)
Time frame: up to 1 year
Quality of life of patients during treatment
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
Time frame: up to 1 year
Dose-reduction
to identify the percentage of patients who require a reduction in dosage due to suboptimal treatment tolerance
Time frame: up to 1 year
Treatment discontinuation
Identify the percentage of patients who discontinues cancer therapy due to suboptimal treatment tolerance
Time frame: up to 1 year
AEs - level of distress
difference in distress levels measured with Distress thermometer between patients with different AEs secondary to cancer treatments
Time frame: up to 1 year
To describe the actions taken to manage treatment-related AEs
Description of the actions taken to manage treatment-related AEs
Time frame: up to 1 year
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Analyze the level of concordance between the AEs detected by health care personnel and the patient's subjective assessment
Concordance between the AEs detected by health care personnel and the patient's subjective assessment
Time frame: up to 1 year
Sources of distress
Frequency for answers to Distress thermometer problem list
Time frame: up to 1 year