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

NCT07763587 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

OTHER

Acupuncture

In the intervention group, personalized interventions (manual acupuncture, auricular point pressing, and combined manual acupuncture plus auricular point pressing) were selected through shared decision-making between physicians and patients.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    collaborator UNKNOWN

  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-01-31
Completion
2028-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07763587 on ClinicalTrials.gov