Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07483034
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Breast Cancer (Ca mammae, C50),
* Age: 18-65 years
* Treatment at the University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia
* Hospitalization during perioperative period while undergoing primary surgical removal of malignant neoplasm (segmentectomy or mastectomy with axillary lymph node dissection or sentinel lymph node biopsy; including possible reconstruction in the same surgery after mastectomy)
* Administration of systemic oncological treatment - adjuvant chemotherapy (anthracycline or taxane-based cytostatics)
* First occurrence of malignant disease
* Early invasive breast cancer
* Absence of metastases
* Possible positive axillary lymph nodes
* No history of hearing impairment
Exclusion Criteria:
* Presence of primary malignant process in other organs
* Ductal carcinoma in situ
* Previous malignant disease
* Recurrence of Breast Cancer
* Prior chemotherapy
* Neoadjuvant chemotherapy
* Diagnosis of anxiety and depressive disorders in the past three years
* Other severe psychiatric disorders (bipolar disorder, schizophrenia)
* Use of psychopharmacotherapy
* Inability to read and write in Croatian
* Presence of intellectual disabilities
* Professional musicians (classical music)
* Use of a hearing aid
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07483034
Study Brief:
Protocol Section:
NCT07483034