Exploring how psychological stress affects breast cancer treatment outcomes
The Association of Psychological Stress with the Efficacy of Neoadjuvant Therapy in Breast Cancer
Shengjing Hospital · NCT06690645
This study looks at how stress and emotions like anxiety and depression might affect how well chemotherapy works for people with breast cancer who are just starting treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 840 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shengjing Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06690645 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between psychological stress and the effectiveness of neoadjuvant chemotherapy in breast cancer patients. It focuses on treatment-naive individuals who have a confirmed diagnosis of breast cancer and are set to receive standard neoadjuvant therapy. The study aims to assess how factors such as anxiety and depression may influence the therapeutic response, given that emotional distress is prevalent among cancer patients. By understanding these dynamics, the research seeks to shed light on the potential impact of psychological factors on cancer treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include treatment-naive adults aged 18 and older with a confirmed diagnosis of breast cancer who are about to receive neoadjuvant therapy.
Not a fit: Patients with concurrent acute or chronic psychiatric disorders or those who have received antidepressant or anti-anxiety therapy within the past month may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that consider psychological well-being in breast cancer patients.
How similar studies have performed: While the role of psychological factors in cancer treatment is increasingly recognized, this specific investigation into their association with neoadjuvant therapy efficacy in breast cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shenyang, Liaoning
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)
Study contacts
- Study coordinator: Liu Hua, Ph. D
- Email: 20242027@cmu.edu.cn
- Phone: 15140067366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, psychological stress, breast cancer