RecruitingNCT06994377

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

Sponsor

European Institute of Oncology

Enrollment

1,000 participants

Start Date

Jun 25, 2025

Study Type

OBSERVATIONAL

Conditions

Metastatic Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring how emotional distress (anxiety, depression, fear of cancer progression) affects quality of life in patients with metastatic breast cancer who are just starting their first line of treatment, across all major breast cancer subtypes. **You may be eligible if...** - You are 18 or older with confirmed metastatic breast cancer - You are about to begin your first treatment for advanced/metastatic disease - Your treatment plan matches one of the four study cohorts (triple-negative, hormone receptor-positive, or HER2-positive) - You have measurable disease on scans - You are able to give informed consent and complete questionnaires **You may NOT be eligible if...** - You have a severe pre-existing psychiatric disorder - You have had another cancer in the past 3 years - You have symptomatic brain metastases - You are currently on antidepressant or anti-anxiety medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALED and quality of life assessment

Patients will undergo ED and quality of life assessments through specific questionnaires completion

Locations(37)

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

Ospedale Policlinico San Martino

Genova, Italy

AOU Gaetano Martino di Messina

Messina, Italy

European Institute of Oncology

Milan, Italy

ASST Fatebenefratelli Sacco

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Ospedale Niguarda

Milan, Italy

Ospedale San Giuseppe MultiMedica

Milan, Italy

Policlinico di Milano

Milan, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy

Ospedale Maggiore di Novara

Novara, Italy

Policlinico Universitario Paolo Giaccone

Palermo, Italy

Policlinico San Matteo

Pavia, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Azienda Usl Toscana centro - Ospedale di Prato Santo Stefano

Prato, Italy

Ospedale Infermi

Rimini, Italy

Policlinico Universitario Campus Bio-Medico

Roma, Italy

Policlinico Umberto I

Rome, Italy

Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Azienda Ospedaliero Universitaria di Sassari

Sassari, Italy

ASL CN2 - Ospedale Michele e Pietro Ferrero

Verduno, Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Ospedale Sacro Cuore Don Calabria - Negrar

Verona, Italy

ASST Brianza

Vimercate, Italy

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NCT06994377

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