Digital music-and-biofeedback mind-body program during pre-surgery chemotherapy for 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
This trial tests a smartphone-delivered music and biofeedback mind-body program to help people with locally advanced breast cancer who are receiving neoadjuvant therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07541664 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult women with histologically confirmed locally advanced invasive breast cancer scheduled for neoadjuvant therapy who screen positive for at least mild anxiety, depression, insomnia, or psychological distress and who own and can use a smartphone and have normal hearing.
Not a fit: Patients with distant metastasis, severe hearing impairment, no smartphone or inability to use mobile apps, or without meaningful baseline psychosocial symptoms are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could reduce anxiety, depression, and insomnia and improve coping and quality of life during neoadjuvant treatment.
How similar studies have performed: Related digital and music-based mind-body interventions in cancer care have shown modest improvements in anxiety and quality of life, but biofeedback-integrated DMBT specifically during neoadjuvant breast cancer treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.