NCT06994377

Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy

The Impact of Emotional Distress on First Line Therapy in Patients With Metastatic Breast Cancer (EIRENE): a Prospective Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	ED and quality of life assessment	Patients will undergo ED and quality of life assessments through specific questionnaires completion

Timeline

• Start date: 2025-06-25
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2025-05-29
• Last updated: 2026-03-25

Locations

37 sites across 1 country: Italy