Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07541664

Digital Mind-Body Therapy for Neoadjuvant Breast Cancer

Led by Fudan University · Updated on 2026-04-21

66

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a single-center, randomized controlled, prospective trial investigating the application of Digital Mind-Body Therapy based on digital music and biofeedback (DMBT) during neoadjuvant treatment in patients with locally advanced breast cancer.

CONDITIONS

Official Title

Digital Mind-Body Therapy for Neoadjuvant Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  1. Participants voluntarily agree to take part in this study and provide written informed consent.
  2. Female, aged ≥18 years.
  3. Histologically confirmed invasive breast cancer.
  4. Planned to receive neoadjuvant therapy.
  5. Completion of psychosomatic assessment prior to initiation of neoadjuvant therapy, with at least two of the following domains reaching mild or higher severity: anxiety, depression, insomnia, or psychological distress (severity classified according to established clinical cut-off values of the respective assessment scales).
  6. Good compliance and willingness to adhere to follow-up.
  7. Normal hearing, without severe hearing impairment.
  8. Possession of a smartphone and ability to independently operate mobile applications.
Not Eligible

You will not qualify if you...

  1. Presence of distant metastasis.
  2. History of other malignancies, except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancers with disease-free survival >5 years.
  3. Immunodeficiency or human immunodeficiency virus (HIV) infection.
  4. Severe dysfunction of the heart, lungs, liver, or kidneys.
  5. Uncontrolled infection or active infection.
  6. Pregnant or lactating women.
  7. Markedly abnormal psychological or cognitive status that precludes completion of psychosomatic assessment.
  8. Prior diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychiatric disorders secondary to medical conditions.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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