[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636798":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":27,"responsibleParty":50,"collaborators":27,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":27,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":27,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":89,"whyStopped":27,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":27},{"fullName":5,"class":6},"Universitas Airlangga","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Brief-ACT + Neoadjuvant Chemotherapy","EXPERIMENTAL","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.",[13,14],"Behavioral: Brief Acceptance and Commitment Therapy","Drug: Neoadjuvant Chemotherapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Counseling + Neoadjuvant Chemotherapy","ACTIVE_COMPARATOR","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.",[20,14],"Behavioral: Standard Counseling",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Brief Acceptance and Commitment Therapy","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.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Standard Counseling","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.",[16],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Neoadjuvant Chemotherapy","Standard neoadjuvant chemotherapy regimen administered according to institutional protocols for locally advanced breast cancer.",[9,16],[38,39],"Neoadjuvant Chemotherapy (NACT)","Neoadjuvant systemic therapy",[41],{"name":42,"affiliation":5,"role":43},"Asdi Wihandono, MD, Surgical Oncologist","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":27,"email":49},"Vania Idelia Winantyo, MD, General Surgeon","CONTACT","+6281906000050","vania.winantyo@gmail.com",{"type":43,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Vania Idelia Winantyo","Surgeon","100636798","targeting-stress-driven-inflammatory-and-angiogenic-pathways-with-brief-act-to-enhance-neoadjuvant-chemotherapy-response-in-locally-advanced-breast-cancer-100636798",false,"NCT07570368","Targeting Stress-Driven Inflammatory and Angiogenic Pathways With Brief ACT to Enhance Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer","Effect of Brief Acceptance and Commitment Therapy on Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer Through Modulation of Inflammatory and Angiogenic Biomarkers.","Inclusion Criteria:\n\n* Female patients aged 40-65 years\n* Histologically confirmed locally advanced breast cancer\n* Planned to undergo neoadjuvant chemotherapy\n* ECOG performance status 0-2\n* Able to provide informed consent\n* Willing to participate in psychological intervention sessions\n\nExclusion Criteria:\n\n* Severe psychological distress defined as Perceived Stress Scale (PSS-10) score ≥27\n* Active infection or inflammatory disease\n* Known autoimmune disease\n* Cognitive impairment or psychiatric condition interfering with participation\n* Concurrent participation in another interventional study","FEMALE","40 Years","65 Years",{"count":64,"type":65},54,"ESTIMATED","INTERVENTIONAL",[68],"NA","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.\n\nThe main questions this study aims to answer are:\n\nDoes 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?\n\nResearchers 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.\n\nParticipants will:\n\nReceive 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",[71,72,73,74],"Breast Cancer","Breast Neoplasm Female","Locally Advanced Breast Cancer (LABC)","Locally Advanced Breast Cancer",[76,77,78,79,80,81,82,83,84,85,86,87,88],"breast cancer","Locally advanced breast cancer","brief acceptance and commitment therapy","acceptance and commitment therapy","neoadjuvant chemotherapy","clinical chemotherapy response","inflammatory biomarkers","angiogenic biomarkers","interleukin-6","neutrophil to lymphocyte ratio","vascular endothelial growth factor","psychological stress","psycho-oncology","NOT_YET_RECRUITING","2026-04-29",{"date":92,"type":93},"2026-05-06","ACTUAL",{"date":95,"type":65},"2026-04-28",{"date":97,"type":65},"2027-01",{"name":5,"class":6}]