Breast NeoplasmsNCT07763587
Analysis of Multimodal Psychosomatic Comorbidity Burden in Breast Cancer and Benefit Evaluation of Acupuncture Collaborative Management Regimen
A study testing Acupuncture in people with Breast Neoplasms, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 3 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 3 sitesChina
- Study dates
- 1 Aug 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
Li li, Ph.D, 18222626653, lilitcm@foxmail.com
- Recruiting
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin
Wang Hailong, Ph.D, 13021368172, 13021368172@163.com
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Wang Bin, 13820156627, wbin8888@163.com
About this study
Official title: 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.
- Conditions
- Breast Neoplasms
- Being tested
- Acupuncture
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Acupuncture、Auricular point pressing Receives: Other: Acupuncture |
| routine nursing control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy-Breast, FACT-B
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.
Measured: 8 weeks
Secondary outcomes (4)
Hospital anxiety and depression scale,HADS
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.
Measured: 8 weeks
Pittsburgh sleep quality index，PSQI
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.
Measured: 8 weeks
Brief Fatigue Inventory，BFI
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.
Measured: 8 weeks
Brief Pain Inventory，BPI
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Aug 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
- Responsible party
- Principal investigator, Li Li, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763587
- Sponsor's protocol ID
- 2026006
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial on Acupuncture Intervention to Alleviate Multifaceted Psychosomatic Comorbidities Among Breast Cancer Patients Based on Shared Decision-Making Model
- ClinicalTrials.gov ID
- NCT07763587
- Acronym / sponsor ID
- 2026006
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: AcupunctureAcupuncture、Auricular point pressing |
| routine nursing control group | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Auricular point pressingIn 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. | Other | Acupuncture group |
Primary outcome
Functional Assessment of Cancer Therapy-Breast, FACT-B
Time frame: 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.
4 secondary outcomes
Hospital anxiety and depression scale,HADS
Time frame: 8 weeks
Pittsburgh sleep quality index，PSQI
Time frame: 8 weeks
Brief Fatigue Inventory，BFI
Time frame: 8 weeks
Brief Pain Inventory，BPI
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Breast Neoplasms, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LI LI, Doctor of Philosophy (18222626653, lilitcm@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy-Breast, FACT-B (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.