Clinical Trial

Analysis of Multimodal Psychosomatic Comorbidity Burden in Breast Cancer and Benefit Evaluation of Acupuncture Collaborative Management Regimen

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Summary
This study adopts a multicenter, pragmatic, umbrella randomized controlled trial design integrated with the shared decision-making (SDM) model. Patients are stratified into four subgroups based on their core psychosomatic symptom phenotypes (single symptom vs. multiple comorbid symptoms). Participants are randomly assigned to the intervention group or control group at a 2:1 allocation ratio. For the intervention group, personalized interventions (including manual acupuncture, auricular point pressing, and combined manual acupuncture plus auricular point pressing) are selected via shared decision-making between clinicians and patients, while the control group receives routine nursing care. The study evaluates the improvement efficacy of single symptoms and the synergistic relief effect of multiple co-occurring symptoms across all psychosomatic phenotype subgroups under the shared decision-making framework. This design addresses the limitation of conventional randomized controlled trials that only focus on individual symptoms, and better fits real-world clinical scenarios characterized by multimorbid coexistence.
Trial Details
NCT Number NCT07763587
Lead Sponsor First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Collaborators: Tianjin Medical University Cancer Institute and Hospital, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Conditions Breast Neoplasms
Enrollment 216 participants
Start Date 2026-08-01
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-13