A Pragmatic Randomized Controlled Trial on Acupuncture Intervention to Alleviate Multifaceted Psychosomatic Comorbidities Among Breast Cancer Patients Based on Shared Decision-Making Model
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 3
- 主要终点
- Functional Assessment of Cancer Therapy-Breast, FACT-B
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Acupuncture group
Acupuncture、Auricular point pressing
干预措施: Acupuncture (Other)
routine nursing control group
结局指标
主要结局
Functional Assessment of Cancer Therapy-Breast, FACT-B
时间窗: 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.
次要结局
- Hospital anxiety and depression scale,HADS(8 weeks)
- Pittsburgh sleep quality index，PSQI(8 weeks)
- Brief Fatigue Inventory，BFI(8 weeks)
- Brief Pain Inventory，BPI(8 weeks)
研究者
Li Li
Associate Research Fellow
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine