Clinical trial · Interventional
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
NCT07541664CI-TRIAL-00109000recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DMBT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- If a patient has locally advanced breast cancer, requires neoadjuvant therapy, and is randomly assigned to the control arm
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- If a patient has locally advanced breast cancer, requires neoadjuvant therapy, and is randomly assigned to the experimental arm
- interventionNames
- Behavioral: DMBT
Primary outcomes (1)
- measure
- Insomnia severity
- timeFrame
- Baseline and up to 24 weeks
- description
- Sleep disturbance assessed by Insomnia Severity Index(ISI)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.