Actively Recruiting
Effectiveness and Safety of Digital Mind-Body Therapy Using Music and Biofeedback in Locally Advanced Breast Cancer Patients Undergoing Neoadjuvant Treatment
Led by Fudan University · Updated on 2026-04-21
66
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a Digital Mind-Body Therapy based on digital music and biofeedback (DMBT) for patients with locally advanced breast cancer undergoing neoadjuvant treatment. This randomized controlled trial aims to assess the therapy's effects on symptoms like insomnia, distress, depression, anxiety, quality of life, cognitive function, and cancer-related fatigue during treatment. Participants are randomly assigned to either an experimental group receiving the DMBT intervention or a control group with no additional intervention. The study involves a single center and follows patients from the start of neoadjuvant therapy through 24 weeks, monitoring various psychological and physical symptoms. During the study, participants will complete psychosomatic assessments and use a smartphone app to engage with the therapy if assigned to the experimental arm. Researchers will measure insomnia severity as the primary outcome and other symptoms such as distress, depression, anxiety, quality of life, cognitive function, and fatigue as secondary outcomes. The study includes follow-up evaluations over 24 weeks to track changes and effects of the therapy throughout treatment.
CONDITIONS
Brief Title
Digital Mind-Body Therapy for Neoadjuvant Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants voluntarily agree to participate and provide written informed consent
- Female, aged 18 years or older
- Histologically confirmed invasive breast cancer
- Planned to receive neoadjuvant therapy
- Psychosomatic assessment prior to neoadjuvant therapy shows mild or higher severity in at least two of anxiety, depression, insomnia, or psychological distress
- Good compliance and willingness to follow up
- Normal hearing without severe impairment
- Owns a smartphone and can operate mobile applications independently
You will not qualify if you...
- Presence of distant metastasis
- History of other malignancies except adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancers with disease-free survival over 5 years
- Immunodeficiency or HIV infection
- Severe heart, lung, liver, or kidney dysfunction
- Uncontrolled or active infection
- Pregnant or lactating women
- Markedly abnormal psychological or cognitive status preventing psychosomatic assessment completion
- Prior diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychiatric disorders secondary to medical conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks
Participants engage in digital mind-body therapy using music and biofeedback alongside their neoadjuvant breast cancer treatment.
Regular use of the digital therapy via smartphone during neoadjuvant treatment
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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