Digital Mind-Body Therapy for Neoadjuvant Breast Cancer
Recruiting · NCT07541664 · Interventional (participants receive a specific treatment) · Lead sponsor: Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
DMBT
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
1 location listed.
- Fudan University Shanghai Cancer Center - Shanghai, Shanghai Municipality, China