Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Location status: Recruiting
NCT Number: NCT06690645
This study aims to explore the relationship between psychological stress and the therapeutic response in breast cancer patients who have received standard neoadjuvant chemotherapy.
Interested in participating?
Request Info18 year and older
Female
Observational
Shenyang, Liaoning, 110004, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 2 years
pCR is defined as the absence of viable tumor cells in both the tumor bed and lymph nodes. The pCR rate refers to the percentage of patients who achieve this complete response.
Time frame: 2 years
Quality of Life (QoL) is assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B, Version 4.0).
Time frame: 2 years
The stress biomarkers, including cortisol and adrenocorticotropic hormone (ACTH), were measured to evaluate the association between peripheral stress biomarkers and the efficacy of neoadjuvant therapy.
Time frame: 2 years
The objective response rate refers to the proportion of patients whose tumor volume has decreased to a predetermined value and who can maintain that reduction for the minimum required duration.
Contact information is provided by the study sponsor or research team.
Liu Cai Gang, Ph. D
CONTACT
Liu Hua, Ph. D
CONTACT
Shengjing Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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