Analysis of Multimodal Psychosomatic Comorbidity Burden in Breast Cancer and Benefit Evaluation of Acupuncture Collaborative Management Regimen
2026年9月11日 更新者：Li Li、First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
A Pragmatic Randomized Controlled Trial on Acupuncture Intervention to Alleviate Multifaceted Psychosomatic Comorbidities Among Breast Cancer Patients Based on Shared Decision-Making Model
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.
研究概览
研究类型
介入性
注册 (估计的)
216
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：LI LI, Doctor of Philosophy
- 电话号码：18222626653
- 邮箱：lilitcm@foxmail.com
学习地点
-
-
-
Tianjin、中国
- 招聘中
- Tianjin Medical University Cancer Institute and Hospital
-
接触：
- Wang Bin
- 电话号码：13820156627
- 邮箱：wbin8888@163.com
-
Tianjin、中国
- 招聘中
- Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
-
接触：
- Wang Hailong, Ph.D
- 电话号码：13021368172
- 邮箱：13021368172@163.com
-
Tianjin、中国
- 招聘中
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
-
接触：
- Li li, Ph.D
- 电话号码：18222626653
- 邮箱：lilitcm@foxmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Acupuncture group
Acupuncture、Auricular point pressing
|
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.
其他名称：
|
|
无干预：routine nursing control group
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Functional Assessment of Cancer Therapy-Breast, FACT-B
大体时间：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.
|
8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hospital anxiety and depression scale,HADS
大体时间：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. |
8 weeks
|
|
Pittsburgh sleep quality index，PSQI
大体时间：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.
|
8 weeks
|
|
Brief Fatigue Inventory，BFI
大体时间：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. |
8 weeks
|
|
Brief Pain Inventory，BPI
大体时间：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
|
8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月1日
初级完成 (估计的)
2028年1月31日
研究完成 (估计的)
2028年3月31日
研究注册日期
首次提交
2026年7月3日
首先提交符合 QC 标准的
2026年8月12日
首次发布 (实际的)
2026年8月13日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月11日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.