Analysis of Multimodal Psychosomatic Comorbidity Burden in Breast Cancer and Benefit Evaluation of Acupuncture Collaborative Management Regimen
Recruiting · NCT07763587 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
3 locations listed.
- 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