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

RecruitingNAAges 18 Years - 70 YearsFemaleFirst Teaching Hospital of Tianjin University of โ€ฆ
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 8;Sleep disturbance: total score of the PSQI โ‰ฅ 8;Cancer-related fatigue: total score of the BFI โ‰ฅ 4; * Expected survival time โ‰ฅ 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.
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What it tests

  • Acupuncture
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Where

3 sites
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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