NCT07541664Recruiting
Digital Mind-Body Therapy for Neoadjuvant Breast Cancer
Effectiveness and Safety of a Digital Mind-Body Therapy Based on Digital Music and Biofeedback in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Treatment
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 8 Apr 2026
- Start date
- Mar 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Fudan University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07541664
What you commit to
- Study type: Interventional
- Planned participants: 66
- From Mar 2026 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychiatric disorders secondary to medical conditions.
Other illness
- Immunodeficiency or human immunodeficiency virus (HIV) infection.
- Severe dysfunction of the heart, lungs, liver, or kidneys.
- Uncontrolled infection or active infection.
Age
- 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.
Other
- Presence of distant metastasis.
- Pregnant or lactating women.
- Markedly abnormal psychological or cognitive status that precludes completion of psychosomatic assessment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.