Digital Mind-Body Therapy for Neoadjuvant Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DMBT.
- Who it may be relevant to
- Registry conditions: Neoadjuvant Therapy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Behavioral DMBT
a Digital Mind-Body Therapy Based on Digital Music and Biofeedback
Primary outcome measures
- Insomnia severity [Time frame: Baseline and up to 24 weeks]
Secondary outcome measures (6)
- Distress [Time frame: Baseline and up to 24 weeks]
- Depression [Time frame: Baseline and up to 24 weeks]
- Anxiety [Time frame: Baseline and up to 24 weeks]
- QoL [Time frame: Baseline and up to 24 weeks]
- Cognitive function [Time frame: Baseline and up to 24 weeks]
- Cancer-related fatigue [Time frame: Baseline and up to 24 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07541664 · BCR2026-01