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

11. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

216

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
      • Tianjin, Kina
        • Rekruttering
        • Tianjin Medical University Cancer Institute and Hospital
        • Ta kontakt med:
      • Tianjin, Kina
        • Rekruttering
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
        • Ta kontakt med:
      • Tianjin, Kina
        • Rekruttering
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Acupuncture group
Acupuncture、Auricular point pressing
Annen: Acupuncture
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.
Andre navn:
  • Auricular point pressing
Ingen inngripen: routine nursing control group

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Functional Assessment of Cancer Therapy-Breast, FACT-B
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hospital anxiety and depression scale,HADS
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Samarbeidspartnere

Tianjin Medical University Cancer Institute and Hospital
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2026

Primær fullføring (Antatt)

31. januar 2028

Studiet fullført (Antatt)

31. mars 2028

Datoer for studieregistrering

Først innsendt

3. juli 2026

Først innsendt som oppfylte QC-kriteriene

12. august 2026

Først lagt ut (Faktiske)

13. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026006

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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