Neoadjuvant Therapy
Conditions
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.
Interventions
BEHAVIORALDMBT
a Digital Mind-Body Therapy Based on Digital Music and Biofeedback
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia severity | Baseline and up to 24 weeks | Sleep disturbance assessed by Insomnia Severity Index(ISI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distress | Baseline and up to 24 weeks | Psychological distress assessed by Distress Thermometer(DT) |
| Depression | Baseline and up to 24 weeks | Depression assessed by Patient Health Questionnaire-9(PHQ-9) |
| Anxiety | Baseline and up to 24 weeks | Anxiety assessed by Generalized Anxiety Disorder 7-item scale(GAD-7) |
| QoL | Baseline and up to 24 weeks | Quality of Life assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module |
| Cognitive function | Baseline and up to 24 weeks | Cognitive function assessed by Functional Assessment of Cancer Therapy-Cognitive Function Version 3 (FACT-Cog V3) |
| Cancer-related fatigue | Baseline and up to 24 weeks | Cancer-related fatigue assessed by Cancer Fatigue Scale (CFS) |
Countries
China
Outcome results
None listed