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NCT Number: NCT07541664

Digital Mind-Body Therapy for Neoadjuvant Breast Cancer

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DMBT

Behavioral

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

Primary outcomes

  1. Insomnia severity

    Time frame: Baseline and up to 24 weeks

    Sleep disturbance assessed by Insomnia Severity Index(ISI)

Secondary outcomes

  1. Distress

    Time frame: Baseline and up to 24 weeks

    Psychological distress assessed by Distress Thermometer(DT)

  2. Depression

    Time frame: Baseline and up to 24 weeks

    Depression assessed by Patient Health Questionnaire-9(PHQ-9)

  3. Anxiety

    Time frame: Baseline and up to 24 weeks

    Anxiety assessed by Generalized Anxiety Disorder 7-item scale(GAD-7)

  4. QoL

    Time frame: Baseline and up to 24 weeks

    Quality of Life assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module

  5. Cognitive function

    Time frame: Baseline and up to 24 weeks

    Cognitive function assessed by Functional Assessment of Cancer Therapy-Cognitive Function Version 3 (FACT-Cog V3)

  6. Cancer-related fatigue

    Time frame: Baseline and up to 24 weeks

    Cancer-related fatigue assessed by Cancer Fatigue Scale (CFS)

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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