About this trial
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
Eligibility criteria
Qualifiers
Female patients aged 40-65 years
Histologically confirmed locally advanced breast cancer
Planned to undergo neoadjuvant chemotherapy
ECOG performance status 0-2
Disqualifiers
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
Trial design
Treatments tested in this trial
- Brief Acceptance and Commitment Therapy
- Standard Counseling
- Neoadjuvant Chemotherapy