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

NCT ID: NCT06690645

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 840 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

Breast cancer is the most common malignant tumor among women. Approximately 19% to 30% of patients with breast cancer achieve a pathological complete response (pCR) following neoadjuvant therapy, while about 5% to 20% of patients experience disease progression. Increasing evidence suggests the significant role of psychological factors in influencing cancer treatment outcomes. Cancer patients often experience emotional distress, including fear of relapse, anxiety, depression, and low self-esteem, which may persist for many years. Statistics indicate that the incidence of anxiety and depression among cancer patients is 49.69% and 54.90%, respectively, significantly higher than that of healthy individuals (anxiety: 18.37%, depression: 17.50%) in China. There are indications that emotional issues may be linked to cancer treatment, although the underlying mechanisms remain unclear.

This study aims to investigate the relationship between anxiety and depression and the effectiveness of standard neoadjuvant therapy in patients with breast cancer.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Exposure: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1.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 Criteria

• 1. Breast cancer has not been confirmed through histological or cytological examinations.

2.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.

5.Participants must not have engaged in any other clinical trials in the past month, unless those trials are observational or non-interventional in nature.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Caigang Liu

Director of oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liu Hua, Ph. D

Role: CONTACT

20242027@cmu.edu.cn

15140067366

Liu Cai Gang, Ph. D

Role: CONTACT

20242027@cmu.edu.cn

15140067366

Facility Contacts

Niu Nan, MD

Role: primary

2951878628@qq.com

024-96615-31813

Other Identifiers

MUKDEN-STRESS

Identifier Type: -

Identifier Source: org_study_id