Digital Mind-Body Therapy for Neoadjuvant Breast Cancer
ConditionNeoadjuvant Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
DMBT
Behaviorala Digital Mind-Body Therapy Based on Digital Music and Biofeedback
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Control ArmNo intervention 0 interventions
Group B: Experimental ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Insomnia severity
Sleep disturbance assessed by Insomnia Severity Index(ISI)
Time frame
Baseline and up to 24 weeksSecondary outcomes
1
Distress
Psychological distress assessed by Distress Thermometer(DT)
Time frame
Baseline and up to 24 weeks2
Depression
Depression assessed by Patient Health Questionnaire-9(PHQ-9)
Time frame
Baseline and up to 24 weeks3
Anxiety
Anxiety assessed by Generalized Anxiety Disorder 7-item scale(GAD-7)
Time frame
Baseline and up to 24 weeks4
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 weeksSponsors and contacts
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Source ClinicalTrials.gov