Analysis of Multimodal Psychosomatic Comorbidity Burden in Breast Cancer and Benefit Evaluation of Acupuncture Collaborative Management Regimen

NCT07763587 | Not Yet Recruiting

• 1 other identifier: 2026006
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Acupuncture group

EXPERIMENTAL

Acupuncture、Auricular point pressing

Other: Acupuncture

routine nursing control group

NO INTERVENTION

Interventions

Acupuncture OTHER

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.

Also known as: Auricular point pressing

Acupuncture group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: lead
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

LI LI, Doctor of Philosophy

CONTACT

18222626653; lilitcm@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Fellow

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: August 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share