Neoadjuvant TherapyNCT07541664
Digital Mind-Body Therapy for Neoadjuvant Breast Cancer
A study testing DMBT in people with Neoadjuvant Therapy, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoadjuvant Therapy
- What is being tested?
- DMBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Keda Yu, MD, PhD, 86-21-64175590-88808, yukeda@fudan.edu.cn
Lichen Tang, MD, +86-18017317708, Forever_drawer@163.com
About this study
Official title: 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.
- Conditions
- Neoadjuvant Therapy
- Being tested
- DMBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMBTBehavioural
a Digital Mind-Body Therapy Based on Digital Music and Biofeedback
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: DMBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity
Sleep disturbance assessed by Insomnia Severity Index(ISI)
Measured: Baseline and up to 24 weeks
Secondary outcomes (6)
Distress
Psychological distress assessed by Distress Thermometer(DT)
Measured: Baseline and up to 24 weeks
Depression
Depression assessed by Patient Health Questionnaire-9(PHQ-9)
Measured: Baseline and up to 24 weeks
Anxiety
Anxiety assessed by Generalized Anxiety Disorder 7-item scale(GAD-7)
Measured: 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
Measured: Baseline and up to 24 weeks
Cognitive function
Cognitive function assessed by Functional Assessment of Cancer Therapy-Cognitive Function Version 3 (FACT-Cog V3)
Measured: Baseline and up to 24 weeks
Cancer-related fatigue
Cancer-related fatigue assessed by Cancer Fatigue Scale (CFS)
Measured: Baseline and up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start25 Mar 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant TherapyStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541664
- Sponsor's protocol ID
- BCR2026-01
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07541664
- Acronym / sponsor ID
- BCR2026-01
- Conditions
- Neoadjuvant Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: DMBTIf a patient has locally advanced breast cancer, requires neoadjuvant therapy, and is randomly assigned to the experimental arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMBTa Digital Mind-Body Therapy Based on Digital Music and Biofeedback | Behavioural | Experimental Arm |
Primary outcome
Insomnia severity
Time frame: Baseline and up to 24 weeks
Sleep disturbance assessed by Insomnia Severity Index(ISI)
6 secondary outcomes
Distress
Time frame: Baseline and up to 24 weeks
Depression
Time frame: Baseline and up to 24 weeks
Anxiety
Time frame: Baseline and up to 24 weeks
QoL
Time frame: Baseline and up to 24 weeks
Cognitive function
Time frame: Baseline and up to 24 weeks
Cancer-related fatigue
Time frame: Baseline and up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DMBT in people with Neoadjuvant Therapy, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (time frame: Baseline and up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.