Digital Mind-Body Therapy for Neoadjuvant Breast Cancer

Recruiting now · Not applicable

Conditions studied: Neoadjuvant Therapy

In brief

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.

Key facts

Study ID

NCT07541664

Run by

Fudan University

People needed

66

Starts

2026-03-25

Expected to finish

2027-03-31

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants voluntarily agree to take part in this study and provide written informed consent.
• Female, aged ≥18 years.
• Histologically confirmed invasive breast cancer.
• Planned to receive neoadjuvant therapy.
• 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).
• Good compliance and willingness to adhere to follow-up.
• Normal hearing, without severe hearing impairment.
• Possession of a smartphone and ability to independently operate mobile applications.

You may not qualify if…

• Presence of distant metastasis.
• 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.
• Immunodeficiency or human immunodeficiency virus (HIV) infection.
• Severe dysfunction of the heart, lungs, liver, or kidneys.
• Uncontrolled infection or active infection.
• Pregnant or lactating women.
• Markedly abnormal psychological or cognitive status that precludes completion of psychosomatic assessment.
• Prior diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychiatric disorders secondary to medical conditions.

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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