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The Impact of Emotional Distress on First Line Therapy in Patients With Metastatic Breast Cancer (EIRENE): a Prospective Observational Study
Few data about the impact of emotional distress (ED) on treatment efficacy in patients with metastatic breast cancer (mBC) are available. Aim of this study is to assess the outcomes of patients with mBC receiving first-line treatment according to the presence of baseline ED.
Metastatic breast cancer (mBC) is the most incident and prevalent cancer in the world and, according to a recent meta-analysis, 50% of patients with BC report emotional distress (ED). In patients with cancer, ED negatively impacts treatment adherence, ability to self-manage the physical and emotional consequences of cancer symptoms and treatment-related adverse events, and overall quality of life. ED has been shown to directly affect treatment outcomes in patients with breast cancer, with studies demonstrating that psychological well-being plays a critical role in therapeutic success. Furthermore, recent studies showed that baseline ED is associated with a lower efficacy of immunotherapy in patients with non-small cell lung cancer (NSCLC) or melanoma. Few data about the impact of ED on treatment efficacy in patients with mBC are available. In the first line setting patients receive endocrine therapy, chemotherapy, immunotherapy and/or targeted therapy according to the disease subtype. These agents display different mechanisms of action, which involve the immune system at different levels. However, the role of ED on the efficacy of these treatments according to the BC subtype is unknown. Aim of this study is to assess the outcomes of patients with mBC receiving first-line treatment according to the presence of baseline ED.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ospedali Riuniti di Ancona
Ancona, Italy
CRO (Centro di Riferimento Oncologico)
Aviano, Italy
Azienda Usl Toscana centro - Ospedale Santa Maria Annunziata
Bagno a Ripoli, Italy
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
ASST Papa Giovanni XXIII
Bergamo, Italy
ASST Spedali Civili
Brescia, Italy
Ospedale A. Perrino
Brindisi, Italy
ASST della Valle Olona
Busto Arsizio, Italy
Ospedale Valduce
Como, Italy
Ospedale Careggi
Florence, Italy
Start Date
June 25, 2025
Primary Completion Date
June 1, 2029
Completion Date
June 1, 2029
Last Updated
December 4, 2025
1,000
ESTIMATED participants
ED and quality of life assessment
BEHAVIORAL
Lead Sponsor
European Institute of Oncology
NCT06625775
NCT06649331
Data Source & Attribution
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