NCT07541664招募中不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Insomnia severity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control Arm
No Intervention
If a patient has locally advanced breast cancer, requires neoadjuvant therapy, and is randomly assigned to the control arm
Experimental Arm
Experimental
If a patient has locally advanced breast cancer, requires neoadjuvant therapy, and is randomly assigned to the experimental arm
干预措施: DMBT (Behavioral)
结局指标
主要结局
Insomnia severity
时间窗: Baseline and up to 24 weeks
Sleep disturbance assessed by Insomnia Severity Index(ISI)
次要结局
- Distress(Baseline and up to 24 weeks)
- Depression(Baseline and up to 24 weeks)
- Anxiety(Baseline and up to 24 weeks)
- QoL(Baseline and up to 24 weeks)
- Cognitive function(Baseline and up to 24 weeks)
- Cancer-related fatigue(Baseline and up to 24 weeks)
研究者
研究点 (1)
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