Multimodal psychosomatic symptom care for breast cancer: personalized acupuncture care guided by shared decision-making

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, pragmatic umbrella randomized trial uses a shared decision-making model to tailor non-pharmacologic acupuncture interventions to individual psychosomatic symptom profiles in women with breast cancer. Participants are stratified by single or multiple psychosomatic symptoms and randomized 2:1 to receive either personalized acupuncture interventions or routine nursing care. The study aims to assess improvement in single symptoms and any synergistic relief across symptom subgroups within the SDM framework. Enrollment spans several Tianjin-affiliated hospitals, with an emphasis on real-world applicability and patient-centered decision making.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: LI LI, Doctor of Philosophy
• Email: lilitcm@foxmail.com
• Phone: 18222626653

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.