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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
66
a Digital Mind-Body Therapy Based on Digital Music and Biofeedback
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGInsomnia severity
Sleep disturbance assessed by Insomnia Severity Index(ISI)
Time frame: Baseline and up to 24 weeks
Distress
Psychological distress assessed by Distress Thermometer(DT)
Time frame: Baseline and up to 24 weeks
Depression
Depression assessed by Patient Health Questionnaire-9(PHQ-9)
Time frame: Baseline and up to 24 weeks
Anxiety
Anxiety assessed by Generalized Anxiety Disorder 7-item scale(GAD-7)
Time frame: Baseline and up to 24 weeks
QoL
Quality of Life assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module
Time frame: Baseline and up to 24 weeks
Cognitive function
Cognitive function assessed by Functional Assessment of Cancer Therapy-Cognitive Function Version 3 (FACT-Cog V3)
Time frame: Baseline and up to 24 weeks
Cancer-related fatigue
Cancer-related fatigue assessed by Cancer Fatigue Scale (CFS)
Time frame: Baseline and up to 24 weeks
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