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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Patients will undergo ED and quality of life assessments through specific questionnaires completion
Progression-free survival (PFS), according to the presence of ED at T0, in cohort A
Time from T0 (Cycle 1 Day 1) to disease progression or death
Time frame: 2 years
Progression-free survival (PFS), according to the presence of ED at T0, in cohort B, C and D
Time from T0 (Cycle 1 Day 1) to disease progression or death
Time frame: 2 years
Progression-free survival (PFS), according to the presence of ED at T1 (Cycle 3 Day 1)
Time from T0 (Cycle 1 Day 1) to disease progression or death
Time frame: 2 years
Objective response rate (ORR), according to the presence of ED at T0 and T1
Number of partial response or complete response achieved
Time frame: 2 years
Quality of life evaluation
Completion of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC-QLQ-C30 (minimum value: 1, maximum value: 4 - higher scores mean a greater agreement with the statement)
Time frame: 3 months
Fear of cancer progression evaluation
Completion of Fear of Progression Questionnaire (FoP Q) (minimum value: 1, maximum value: 5 - higher total score reflects a higher level of fear of disease progression)
Time frame: 3 months
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