RecruitingNCT06690645

The Association of Psychological Stress with the Efficacy of Neoadjuvant Therapy in Breast Cancer

Sponsor

Shengjing Hospital

Enrollment

840 participants

Start Date

Nov 15, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

Summary

This study aims to explore the relationship between psychological stress and the therapeutic response in breast cancer patients who have received standard neoadjuvant chemotherapy.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

Age ≥ 18 years; 2.Histological and/or cytological diagnosis of breast cancer; 3.Treatment niave patients; 4.To receive standard neoadjuvant therapy; 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ; 7.Informed and agreed to participate in the study;

Exclusion Criteria3

\. Breast cancer has not been confirmed through histological or cytological examinations.
Other breast cancer conditions that do not receive neoadjuvant therapy. 3.Combined with other malignant tumors. 4.Concurrent acute or chronic psychiatric disorders, along with having received antidepressant or anti-anxiety therapy within the past month.
Participants must not have engaged in any other clinical trials in the past month, unless those trials are observational or non-interventional in nature.

Interventions

OTHERExposure: psychological stress status

The assessment of depressive, anxiety or perceived Stress was conducted using PHQ-9, GAD-7 or PSS scale. Patients with a PHQ-9 score ≥ 5 or a GAD-7 score ≥ 5 or a PSS score ≥ 20 were categorized as the stressed group.