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

NCT07763587 · tracked via the Priya Life Science China tracker

Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Phase

Not applicable

Started

2026-08-01

Last updated

2026-09-16

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

Acupuncture

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.

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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * Female patients aged 18 to 70 years old; * Patients with pathologically or cytologically confirmed breast cancer; * Meeting at least one diagnostic criterion for psychosomatic symptoms:Anxiety or depressive state: subscale score of anxiety or depression on the HADS ≥ 8;Sleep disturbance: total score of the PSQI ≥ 8;Cancer-related fatigue: total score of the BFI ≥ 4; * Expected survival time ≥ 1 year; * Clear consciousness, basic communication ability, and capacity to complete scale assessments cooperatively; * Voluntary written informed consent signed by the patient or legal representative. Exclusion Criteria: * Patients with severe mental disorders (such as schizophrenia and bipolar disorder) or lacking civil capacity; * Ineligibility for auricular point pressing intervention: local auricular skin breakage, infection, or allergic constitution (allergy to vaccaria seeds or adhesive plasters); * Patients receiving other acupuncture or acupoint pressing interventions, or those unable to discontinue such treatments during the trial period; * Patients unsuitable for manual acupuncture, including those with bleeding tendency (e.g., coagulation disorders, purpura) or local skin lesions at acupoint sites; * Complicated with severe heart, liver, renal or other organ failure, or cachexia; * Pregnant or lactating women.

Primary outcome measure(s)

Functional Assessment of Cancer Therapy-Breast, FACT-B — 8 weeks
Instruments for assessing Quality of Life (QoL) among breast cancer patients；Functional Assessment of Cancer Therapy-Breast (FACT-B Version 4.0) Uniform response options: 0 = Not at all, 1 = A little bit, 2 = Somewhat, 3 = Quite a bit, 4 = Very much Unified scoring rule for all subscales and total scores: Higher scores indicate better quality of life among breast cancer patients; lower scores reflect more severe physical, emotional, social and breast-specific distress.

Trial sites (3)

Facility	City	Region	Status
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	China	Recruiting
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin	China	Recruiting
Tianjin Medical University Cancer Institute and Hospital	Tianjin	China	Recruiting

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Health Belief Model-Based Survey on Breast Self-Examination Awareness and Practice Among Community-Dwelling Middle-Aged and Older Women Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07763587 on ClinicalTrials.gov ↗ ← All trials in China