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

NCT06690645 | Recruiting DMC

• 1 other identifier: MUKDEN-STRESS
• Study Type: observational
• Target: 840
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

psychological stress, breast cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response (pCR) rate

  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.

  2 years

Secondary Outcomes (3)

• Quality of life

  2 years

• peripheral stress biomarkers

  2 years

• Objective Response Rate (ORR)

  2 years

Interventions

Exposure: psychological stress status OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants included patients diagnosed with breast cancer who were about to receive neoadjuvant therapy.

You may qualify if:

• 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;

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood, tumor tissue

MeSH Terms

Conditions

Breast Neoplasms; Stress, Psychological

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Liu Hua, Ph. D

CONTACT

15140067366; 20242027@cmu.edu.cn

Liu Cai Gang, Ph. D

CONTACT

15140067366; 20242027@cmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of oncology

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)