Digital Mind-Body Therapy for Neoadjuvant Breast Cancer

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

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 Overview

• Status: Recruiting
• Conditions: Neoadjuvant Therapy
• Intervention / Treatment: Behavioral: DMBT

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Keda Yu, MD, PhD; Phone Number: 86-21-64175590-88808; Email: yukeda@fudan.edu.cn
      • Contact: Lichen Tang, MD; Phone Number: +86-18017317708; Email: Forever_drawer@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; If a patient has locally advanced breast cancer, requires neoadjuvant therapy, and is randomly assigned to the control arm
Experimental: Experimental Arm; If a patient has locally advanced breast cancer, requires neoadjuvant therapy, and is randomly assigned to the experimental arm	Behavioral: DMBT; a Digital Mind-Body Therapy Based on Digital Music and Biofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia severity	Sleep disturbance assessed by Insomnia Severity Index(ISI)	Baseline and up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress	Psychological distress assessed by Distress Thermometer(DT)	Baseline and up to 24 weeks
Depression	Depression assessed by Patient Health Questionnaire-9(PHQ-9)	Baseline and up to 24 weeks
Anxiety	Anxiety assessed by Generalized Anxiety Disorder 7-item scale(GAD-7)	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	Baseline and up to 24 weeks
Cognitive function	Cognitive function assessed by Functional Assessment of Cancer Therapy-Cognitive Function Version 3 (FACT-Cog V3)	Baseline and up to 24 weeks
Cancer-related fatigue	Cancer-related fatigue assessed by Cancer Fatigue Scale (CFS)	Baseline and up to 24 weeks

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BCR2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No