Digital Mind-Body Therapy for Neoadjuvant Breast Cancer

NCT07541664 | Recruiting

• 1 other identifier: BCR2026-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Insomnia severity

  Sleep disturbance assessed by Insomnia Severity Index(ISI)

  Baseline and up to 24 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

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

Behavioral: DMBT

Interventions

DMBT BEHAVIORAL

a Digital Mind-Body Therapy Based on Digital Music and Biofeedback

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 21, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)