NCT07541664 Digital Mind-Body Therapy for Neoadjuvant Breast Cancer
| NCT ID | NCT07541664 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Neoadjuvant Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2026-03-25 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2026-03-25 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT07541664 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Neoadjuvant Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07541664 currently recruiting?
Yes, NCT07541664 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fudan University to inquire about joining.
Where is the NCT07541664 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07541664 clinical trial?
NCT07541664 is sponsored by Fudan University. The trial plans to enroll 66 participants.