- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474246
A Innovative Web-based Dance Movement Therapy
Developing and Evaluating the Effect of a Innovative Web-based Dance Movement Therapy on Alexithymia and Frailty in Women With Breast Cancer: An Experimental Study
The goal of this clinical trial is to develop an innovative web-based dance movement therapy (DMT) training platform and assess short-term outcomes before and after its implementation in women with breast cancer
Is the DMT training platform comprehensibility and acceptability among patients? Is the DMT training platform acceptability, usability, and feasibility among healthcare providers? Does the DMT training platform have effects on alexithymia and frailty among patients?
Researchers will compare experimental to a control (a a conventional care program) to see if DMT training platform works to treat severe asthma.
Participants will:
receive an orientation on the web-based DMT program before chemotherapy, along with a single face-to-face traditional education session on physical activity .
complete training sessions three times per week, with each session lasting at least 70 min.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan
- National Yang Ming Chiao Tung University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who were about to start chemotherapy were recruited from a hospital in Taipei, Taiwan
Exclusion Criteria:
- major illness (e.g., heart failure, stroke, blindness) or a pre-existing mental disorder
- a history of limb amputation
- prior participation in dance therapy before their breast cancer diagnosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The web-based DMT training intervention
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Patients in the experimental group received an orientation on the web-based DMT program before chemotherapy, along with a single face-to-face traditional education session on physical activity.
Participants were encouraged to complete training sessions three times per week, with each session lasting at least 70 min.
Each DMT training session was divided into four components: (1) Proprioception; (2)Warm-up and stretching techniques; (3) Main part; (4) Relaxation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alexithymia
Time Frame: one year (2024/08/01-2025/07/31)
|
Alexithymia was assessed using the Chinese version of the Toronto Alexithymia Scale (TAS), a self-reported outcome measure [30-31].
The TAS consists of 20 items covering three key domains: difficulty in identifying and discriminating emotional cues, difficulty in verbally expressing emotions and feelings, and externally oriented thinking.
Each item was rated on a 5-point Likert scale, ranging from 1 to 5, resulting in a total score range of 20 to 100, with higher scores indicating greater alexithymia.
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one year (2024/08/01-2025/07/31)
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Frailty
Time Frame: one year ( 2024/08/01-2025/07/31).
|
A breast cancer comprehensive frailty scale (BCCFS) was developed to assess frailty across three domains: deterioration in body function and mobility, negative emotional states, and cognitive impairment.
The BCCFS comprises 16 items and has demonstrated strong psychometric properties, with a Cronbach's alpha of 0.91, indicating excellent internal consistency, and a test-retest reliability coefficient of 0.60 [32].
The validity and reliability of the BCCFS have been well established.
Responses to each item were recorded on a five-point Likert scale, with higher scores indicating greater perceived frailty.
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one year ( 2024/08/01-2025/07/31).
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MacKay Medical University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
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University of California, IrvineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedBreast Cancer | HER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-positive Breast CancerUnited States
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Joseph Baar, MD, PhDCompletedBreast Cancer | Stage I Breast Cancer | Inflammatory Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast CancerUnited States
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Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
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Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
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