An interventional study of Brief Acceptance and Commitment Therapy and Standard Counseling in Breast Cancer, Breast Neoplasm Female and Locally Advanced Breast Cancer (LABC), sponsored by Universitas Airlangga. Not yet recruiting. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Universitas Airlangga · Not applicable, Interventional, and Treatment
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
Breast cancer patients with locally advanced disease frequently experience substantial psychological distress during treatment, which has been associated with adverse biological effects. Chronic psychological stress may activate neuroendocrine pathways, particularly the hypothalamic-pituitary-adrenal (HPA) axis, leading to increased production of pro-inflammatory cytokines and angiogenic factors. These biological alterations, including elevated levels of interleukin-6 (IL-6), C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), and vascular endothelial growth factor (VEGF), are thought to contribute to tumor progression and resistance to chemotherapy.
Emerging evidence suggests that psychological interventions may influence these biological pathways. Acceptance and Commitment Therapy (ACT), particularly in its brief format (Brief-ACT), has been shown to improve psychological flexibility and reduce stress. However, its potential role in modulating inflammatory and angiogenic biomarkers and improving chemotherapy response in breast cancer patients remains insufficiently explored.
This study is designed as a randomized controlled trial to evaluate the effect of Brief-ACT on treatment response in patients with locally advanced breast cancer undergoing neoadjuvant chemotherapy. The intervention is delivered alongside standard chemotherapy and focuses on enhancing psychological flexibility through core ACT processes, including acceptance, cognitive defusion, present-moment awareness, and value-based action.
In addition to evaluating clinical response, this study investigates the potential biological mechanisms underlying the effect of psychological intervention. Serial measurements of inflammatory and angiogenic biomarkers are performed to assess whether changes in psychological stress are associated with modulation of these pathways. This integrative approach aims to bridge psychological and biological domains in cancer treatment.
The findings of this study are expected to provide evidence on whether a structured psychological intervention can serve as an adjunctive strategy to improve chemotherapy outcomes through modulation of stress-related biological processes. If effective, this approach may support the integration of psychosocial care into standard oncological treatment to enhance both clinical and biological outcomes.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 54 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Universitas Airlangga is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Participants in this arm receive standard neoadjuvant chemotherapy in combination with Brief Acceptance and Commitment Therapy (Brief-ACT). The Brief-ACT intervention is delivered in structured sessions during the course of chemotherapy and focuses on enhancing psychological flexibility through core ACT processes, including acceptance, cognitive defusion, present-moment awareness, and value-based action.
Behavioral: Brief Acceptance and Commitment Therapy · Drug: Neoadjuvant Chemotherapy
Participants in this arm receive standard neoadjuvant chemotherapy along with standard counseling provided as part of routine clinical care. The counseling serves as an attention-control condition to account for non-specific therapeutic effects, without incorporating structured Brief-ACT components.
Behavioral: Standard Counseling · Drug: Neoadjuvant Chemotherapy
Brief 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 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.
Standard neoadjuvant chemotherapy regimen administered according to institutional protocols for locally advanced breast cancer.
Also known as: Neoadjuvant Chemotherapy (NACT), Neoadjuvant systemic therapy
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.
Time frame: At the end of cycle 3 (each cycle is 21 days), prior to surgery
Change in serum interleukin-6 (IL-6) level
Measured in pg/mL using enzyme-linked immunosorbent assay (ELISA)
Time frame: Baseline (prior to initiation of chemotherapy) and after completion of cycle 3 chemotherapy (approximately 9 weeks, each cycle is 21 days)
Change in neutrophil-to-lymphocyte ratio (NLR)
Calculated from complete blood count parameters
Time frame: Baseline (prior to initiation of chemotherapy) and after completion of cycle 3 chemotherapy (approximately 9 weeks, each cycle is 21 days)
Change in serum vascular endothelial growth factor A (VEGF-A) level
Measured in pg/mL using enzyme-linked immunosorbent assay (ELISA)
Time frame: Baseline (prior to initiation of chemotherapy) and after completion of cycle 3 chemotherapy (approximately 9 weeks, each cycle is 21 days)
Change in perceived stress level
Measured using the Perceived Stress Scale-10 (PSS-10)
Time frame: Baseline (prior to intervention), and after completion of intervention, approximately 9 weeks after baseline measurement
Change in psychological flexibility measured by Acceptance and Action Questionnaire-II (AAQ-II)
Measured using the Acceptance and Action Questionnaire-II (AAQ-II), a self-reported instrument assessing psychological flexibility. Scores typically range from 7 to 49, with higher scores indicating greater psychological inflexibility (lower psychological flexibility)
Time frame: Baseline (prior to initiation of study intervention) and after completion of intervention (approximately 6-9 weeks after baseline)
No study locations are listed for this record.
Plan to share: Undecided — Data sharing plans are currently under consideration. The study team intends to evaluate data sharing options following completion of the study and publication of the primary results, taking into account institutional policies, ethical considerations, and participant confidentiality.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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