Breast Neoplasms
Conditions
Brief 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.
Interventions
OTHERAcupuncture
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
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin Medical University Cancer Institute and Hospital
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital anxiety and depression scale,HADS | 8 weeks | Hospital Anxiety and Depression Scale (HADS) Full Scoring Standard Specifications Subscale 1: Anxiety subscale (HADS-A) Number of items: 7 Minimum score: 0 Maximum score: 21 Interpretation: Higher scores mean more severe anxiety symptoms. Subscale 2: Depression subscale (HADS-D) Number of items: 7 Minimum score: 0 Maximum score: 21 Interpretation: Higher scores mean more severe depressive symptoms. HADS total score Composition: HADS-A score + HADS-D score Minimum score: 0 Maximum score: 42 Interpretation: Higher total scores indicate more severe combined anxiety and depression symptoms. Supplementary Response Option Rule (Standard HADS 4-point Likert) All items adopt 4-point scoring from 0 to 3; higher single item scores stand for worse emotional conditions. |
| Pittsburgh sleep quality index，PSQI | 8 weeks | Pittsburgh Sleep Quality Index (PSQI) Full Scoring Standard Description PSQI component subscores (7 sleep dimensions) Each component score range: 0-3 PSQI global total score Full name: Pittsburgh Sleep Quality Index Global Score Minimum score: 0 Maximum score: 21 Interpretation: Higher global scores represent worse overall sleep quality; lower scores indicate better sleep quality. |
| Brief Fatigue Inventory，BFI | 8 weeks | Brief Fatigue Inventory (BFI) Full Scoring Standard Description Single item scoring range for each fatigue item: 0-10 BFI Global Fatigue Severity Score Full name: Brief Fatigue Inventory Global Fatigue Severity Score Minimum score: 0 Maximum score: 10 Interpretation: Higher scores indicate more severe fatigue; lower scores represent milder fatigue status. Supplement The total global score is the average of all 9 items of the BFI. Each item uses a 0-10 numerical rating scale, where 0 = no fatigue at all and 10 = worst fatigue imaginable. |
| Brief Pain Inventory，BPI | 8 weeks | Brief Pain Inventory (BPI) Full Scoring Standard Description Single item scoring range: Each pain-related item is scored on a 0-10 numeric rating scale (0 = no pain, 10 = worst pain imaginable) BPI Pain Severity Score Full name: Brief Pain Inventory Pain Severity Score Composition: Average score of 4 pain severity items (worst pain, least pain, average pain, pain right now) Minimum score: 0 Maximum score: 10 Interpretation: Higher scores mean greater pain severity BPI Pain Interference Score Full name: Brief Pain Inventory Pain Interference Score Composition: Average score of 7 pain interference items (interference with general activity, mood, walking ability, normal work, relations with others, sleep, enjoyment of life) Minimum score: 0 Maximum score: 10 Interpretation: Higher scores indicate more severe interference of pain on daily life |
Countries
China
Contacts
CONTACTLI LI, Doctor of Philosophy
Outcome results
None listed