Digital Mind-Body Therapy for Neoadjuvant Breast Cancer | NCT07541664

Studies
Digital Mind-Body Therapy for Neoadjuvant Breast Cancer

NCT07541664

Sponsor

Fudan University

Status

Recruiting

Last Update Posted

Apr 21, 2026Actual

Enrollment

66Estimated

Phase

Not Applicable

Conditions

Neoadjuvant Therapy

Interventions

DMBT

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2026Actual

Primary Completion Date

Jan 31, 2027Estimated

Completion Date

Mar 31, 2027Estimated

First Submitted Date

Apr 8, 2026

First Submission Date that Met QC Criteria

Apr 14, 2026

First Posted Date

Apr 21, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2026

Last Update Posted Date

Apr 21, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
DMBT	Behavioral	a Digital Mind-Body Therapy Based on Digital Music and Biofeedback	Experimental Arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided