Digital music-and-biofeedback mind-body program during pre-surgery chemotherapy for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized controlled prospective trial that delivers a Digital Mind-Body Therapy (DMBT) program based on music and physiological biofeedback alongside planned neoadjuvant treatment. Eligible patients are randomized and use a smartphone app with audio interventions and biofeedback monitoring during their treatment course. The trial enrolls adults with invasive, locally advanced breast cancer who show at least mild anxiety, depression, insomnia, or psychological distress on screening. Outcomes will center on feasibility, patient-reported psychosocial symptoms, and adherence during the neoadjuvant period with follow-up while treatment continues.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.