Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
Recruiting · NCT06994377 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
ED and quality of life assessment
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age over 18 years
- Confirmed histological diagnosis of breast cancer
- No prior treatment for advanced/metastatic cancer
- Indication to receive first-line therapy as per standard clinical practice based on the disease subtype:
- cohort A (HR-/HER2-, PD-L1+): pembrolizumab or atezolizumab + chemotherapy
- cohort B (HR-/HER2-, PD-L1-): chemotherapy
- cohort C (HR+/HER2-): CDK4/6 inhibitor + endocrine therapy
- cohort D (HER2+): chemotherapy + trastuzumab and pertuzumab
- Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 and/or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria
- Able to provide full informed consent for the study
Exclusion criteria
- Pre-existing severe psychiatric disorders or other conditions that could impair the ability to provide informed consent
- Inability to complete questionnaires
- Presence of another malignancy in the previous 3 years
- Symptomatic brain metastases
- Ongoing treatment with antidepressant and/or anxiolytic drugs
Where it is running
37 locations listed.
- 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