This clinical trial aims to learn whether a brief psychological therapy called Brief Acceptance and Commitment Therapy (Brief-ACT) can improve the effectiveness of neoadjuvant chemotherapy in patients with locally advanced breast cancer. It will also examine how this therapy affects stress levels and certain blood markers related to inflammation and tumor growth.
The main questions this study aims to answer are:
Does Brief-ACT improve the rate of pathological complete response (pCR) after chemotherapy? Does Brief-ACT reduce levels of inflammatory and angiogenic biomarkers such as C-reactive protein (CRP), interleukin-6 (IL-6), neutrophil-to-lymphocyte ratio (NLR), and vascular endothelial growth factor (VEGF)? Does Brief-ACT reduce psychological stress in patients undergoing chemotherapy?
Researchers will compare patients who receive Brief-ACT in addition to standard chemotherapy with those who receive standard chemotherapy alone to see if there are differences in treatment response, stress levels, and biomarker levels.
Participants will:
Receive neoadjuvant chemotherapy according to standard treatment protocols Be assigned to receive Brief-ACT sessions or no additional psychological intervention Attend regular clinic visits for treatment and monitoring Provide blood samples at specific time points for laboratory analysis Complete questionnaires to assess psychological stress
Female patients aged 40-65 years
Histologically confirmed locally advanced breast cancer
Planned to undergo neoadjuvant chemotherapy
ECOG performance status 0-2
Severe psychological distress defined as Perceived Stress Scale (PSS-10) score ≥27
Active infection or inflammatory disease
Known autoimmune disease
Cognitive impairment or psychiatric condition interfering with participation
Parallel
Brief Acceptance and Commitment Therapy
BehavioralBrief Acceptance and Commitment Therapy (Brief-ACT) is a structured psychological intervention delivered during the course of neoadjuvant chemotherapy. The intervention focuses on enhancing psychological flexibility through core ACT processes, including acceptance, cognitive defusion, present-moment awareness, self-as-context, values clarification, and committed action. Sessions are delivered in a brief format tailored to the clinical setting and are integrated into routine oncology care during chemotherapy cycles.
Standard Counseling
BehavioralStandard counseling consists of routine supportive communication provided as part of standard clinical care during neoadjuvant chemotherapy. This includes general emotional support, basic health education, and non-directive discussion without the use of structured psychotherapeutic techniques such as Acceptance and Commitment Therapy. This intervention serves as an attention-control condition.
Neoadjuvant Chemotherapy
DrugStandard neoadjuvant chemotherapy regimen administered according to institutional protocols for locally advanced breast cancer.
Clinical response according to RECIST version 1.1
Clinical response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on radiologic tumor evaluation. Responses will be categorized as complete response, partial response, stable disease, or progressive disease according to RECIST 1.1 criteria.
Change in serum interleukin-6 (IL-6) level
Measured in pg/mL using enzyme-linked immunosorbent assay (ELISA)
Change in neutrophil-to-lymphocyte ratio (NLR)
Calculated from complete blood count parameters
Change in serum vascular endothelial growth factor A (VEGF-A) level
Measured in pg/mL using enzyme-linked immunosorbent assay (ELISA)
Change in perceived stress level
Measured using the Perceived Stress Scale-10 (PSS-10)
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This trial is not recruiting at the moment. You can still explore other options:
