Breast CancerDance4BCNCT05938686
Home_Based Digital Mindful Dance Program for Breast Cancer Cases
A study testing Home_Based Digital Mindful Dance Program in people with Breast Cancer and Quality of Life, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
During COVID-19, telecare replaces face-to-face contact to maintain social distance and reduce the spread of the virus. The current epidemic is coming to the end. However, for breast cancer cases, no matter in the treatment or survival stage, they face physical and mental symptoms, such as "social isolation", which… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer, Quality of Life
- What is being tested?
- Home_Based Digital Mindful Dance Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer with any stage and any treatment status
Who cannot join
- mental illness
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang-Ming University
Taipei, 11221
IChing Hou, PhD, 886-2-28267000 ext. 7315, evita@ym.edu.tw
IChing Hou, PhD
About this study
Official title: Home_Based Digital Mindful Dance Program for Breast Cancer Cases: Feasibility, Body-Mind Awareness and Quality of Life
During COVID-19, telecare replaces face-to-face contact to maintain social distance and reduce the spread of the virus. The current epidemic is coming to the end. However, for breast cancer cases, no matter in the treatment or survival stage, they face physical and mental symptoms, such as "social isolation", which affects their quality of life. Studies have shown that mindfulness and dance can help breast cancer cases improve depression and quality of life, but most of them are conducted face-to-face. Online mindful/dance helped breast cancer cases without the limitations of the time, space, distance, and treatment status, but lacking enough evidence. The purpose of this study will to design a "home based digital mindful dance program" suitable for our breast cancer cases, and conduct clinical trial on its feasibility, mind and body awareness, and quality of life. Finally, through in-depth interviews, we will understand the subjective experience of breast cancer cases on the program. The research results are expected to provide an empirical reference for multi-care for breast cancer to our country and abroad.
Read the detailed description
Since the outbreak of the COVID-19 global pandemic at the end of 2019, maintaining social distance has become an important strategy to avoid virus infection. Various interventional care intervention that traditionally need to be implemented face-to-face also urgently need to be adjusted to online with the assistance of digital technology tools. Provide (e.g. video clinic).
Although the current epidemic situation has tended to stabilize, however, for breast cancer patients, they are often in a state of "social isolation" physically and mentally from the beginning of diagnosis and treatment to the survival stage after treatment.
Because breast cancer patients often need to receive chemotherapy, they are affected by drugs and produce bone marrow suppression, resulting in lower autoimmune function than normal people. They belong to a high-risk group of infection, and they need to take self-protection measures and reduce going to public places. Even if all cancer treatments have been completed and are in the survival period, some patients may choose to leave the hard-working workplace early due to fear of cancer recurrence or social prejudice to reduce stress and health threats, but they are also worried about the burden on their families and loss of life. Center of gravity, when multiple psychological pressures continue to accumulate, it is easy to cause emotional distress such as anxiety or depression, and it also seriously affects interpersonal relationships and social skills. Therefore, whether it is in the treatment stage or the survival stage, the body and mind often suffer from a negative state like "social isolation" .
Mindfulness is consciously aware of the present body, mind and environment, and maintains an objective, permissive, and non-judgmental attitude. Its exercises include breathing observation, body scanning, meditation, walking, yoga, and relaxation techniques. Dance is a dual-task activity that integrates cognitive, motor, and emotional tasks through a combination of spatial awareness, motor coordination, balance, endurance, and interaction. Past studies have pointed out that mindful dance measures through mindfulness techniques, dance movements, or a combination of the two can help breast cancer patients improve their quality of life, reduce depression, anxiety, pain, fatigue symptoms, improve sleep quality, and reduce the fear of cancer recurrence and many other benefits.
- Conditions
- Breast Cancer, Quality of Life
- Being tested
- Home_Based Digital Mindful Dance Program
- Keywords
- breast cancer, mindfulness, dance, home based digitalization, quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home_Based Digital Mindful Dance ProgramOther
Home_Based Digital Mindful Dance Program including warm up, dance and cool down for 60 minute with 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Home_Based Digital Mindful Dance Program for 12 weeks Receives: Other: Home_Based Digital Mindful Dance Program |
| Control Group | No intervention | Routine care for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline EORTC QLQ-C30
Baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life - Core 30 (version 3). The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Measured: Baseline
Change of EORTC QLQ-C30 at 12th week
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life - Core 30 (version 3) to 12th week. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Measured: 12th week
Baseline QLQ-BR23
Baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life - Breast 23 (version 3). The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Measured: Basline
Change of QLQ-BR23 at 12th week
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life - Breast 23 (version 3) to 12th week. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Measured: 12th week
Baseline Mindful Attention Awareness Scale
Baseline Mindful Attention Awareness Scale. Based on a mean of all items, MAAS scores can range from 1 to 6. Higher scores indicate greater mindfulness
Measured: Basline
Change of Mindful Attention Awareness Scale at 12th week
Change from baseline Mindful Attention Awareness Scale to 12th week. Based on a mean of all items, MAAS scores can range from 1 to 6. Higher scores indicate greater mindfulness
Measured: 12th week
Secondary outcomes (3)
Baseline Physical Activity Scale
Baseline Physical Activity Scale. The minimum and maximum values are 1 and 4, and higher scores mean a better physical activity.
Measured: Basline
Change of Physical Activity Scale at 12th week
Change from baseline Physical Activity Scale to 12th week. The minimum and maximum values are 1 and 4, and higher scores mean a better outcome.
Measured: 12th week
Feasibility Test at 12th week
Feasibility Test at 12th week.The minimum and maximum values are 1 and 4, and higher scores mean a better outcome.
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I-Ching Hou, National Yang Ming Chiao Tung University
- Investigators
- I-Ching Hou, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938686
- Sponsor's protocol ID
- NYCU112051AEF
- Acronym
- Dance4BC
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang YH, Chao YL, Lin YF, Liu PC, Chang KJ, Hou IC. Home-based remote dance program with biopsychosocial model improves quality of life in breast cancer patients: A randomized controlled trial. J Bodyw Mov Ther. 2025 Sep;43:376-385. doi: 10.1016/j.jbmt.2025.04.029. Epub 2025 Apr 17.
PubMed 40483151
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home_Based Digital Mindful Dance Program for Breast Cancer Cases: Feasibility, Body-Mind Awareness and Quality of Life
- ClinicalTrials.gov ID
- NCT05938686
- Acronym / sponsor ID
- Dance4BC / NYCU112051AEF
- Conditions
- Breast Cancer, Quality of Life
- Keywords
- breast cancer, mindfulness, dance, home based digitalization, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 10 Jul 2023 (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.
During COVID-19, telecare replaces face-to-face contact to maintain social distance and reduce the spread of the virus. The current epidemic is coming to the end. However, for breast cancer cases, no matter in the treatment or survival stage, they face physical and mental symptoms, such as "social isolation", which affects their quality of life. Studies have shown that mindfulness and dance can help breast cancer cases improve depression and quality of life, but most of them are conducted face-to-face. Online mindful/dance helped breast cancer cases without the limitations of the time, space, distance, and treatment status, but lacking enough evidence. The purpose of this study will to design a "home based digital mindful dance program" suitable for our breast cancer cases, and conduct clinical trial on its feasibility, mind and body awareness, and quality of life. Finally, through in-depth interviews, we will understand the subjective experience of breast cancer cases on the program. The research results are expected to provide an empirical reference for multi-care for breast cancer to our country and abroad.
Detailed description
Since the outbreak of the COVID-19 global pandemic at the end of 2019, maintaining social distance has become an important strategy to avoid virus infection. Various interventional care intervention that traditionally need to be implemented face-to-face also urgently need to be adjusted to online with the assistance of digital technology tools. Provide (e.g. video clinic).
Although the current epidemic situation has tended to stabilize, however, for breast cancer patients, they are often in a state of "social isolation" physically and mentally from the beginning of diagnosis and treatment to the survival stage after treatment.
Because breast cancer patients often need to receive chemotherapy, they are affected by drugs and produce bone marrow suppression, resulting in lower autoimmune function than normal people. They belong to a high-risk group of infection, and they need to take self-protection measures and reduce going to public places. Even if all cancer treatments have been completed and are in the survival period, some patients may choose to leave the hard-working workplace early due to fear of cancer recurrence or social prejudice to reduce stress and health threats, but they are also worried about the burden on their families and loss of life. Center of gravity, when multiple psychological pressures continue to accumulate, it is easy to cause emotional distress such as anxiety or depression, and it also seriously affects interpersonal relationships and social skills. Therefore, whether it is in the treatment stage or the survival stage, the body and mind often suffer from a negative state like "social isolation" .
Mindfulness is consciously aware of the present body, mind and environment, and maintains an objective, permissive, and non-judgmental attitude. Its exercises include breathing observation, body scanning, meditation, walking, yoga, and relaxation techniques. Dance is a dual-task activity that integrates cognitive, motor, and emotional tasks through a combination of spatial awareness, motor coordination, balance, endurance, and interaction. Past studies have pointed out that mindful dance measures through mindfulness techniques, dance movements, or a combination of the two can help breast cancer patients improve their quality of life, reduce depression, anxiety, pain, fatigue symptoms, improve sleep quality, and reduce the fear of cancer recurrence and many other benefits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Other: Home_Based Digital Mindful Dance ProgramHome_Based Digital Mindful Dance Program for 12 weeks |
| Control Group | No intervention | –Routine care for 12 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- breast cancer with any stage and any treatment status
Key exclusion criteria (1 listed)
- mental illness
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 |
|---|---|---|
| Home_Based Digital Mindful Dance ProgramHome_Based Digital Mindful Dance Program including warm up, dance and cool down for 60 minute with 12 weeks. | Other | Interventional Group |
Primary outcome
Baseline EORTC QLQ-C30
Time frame: Baseline
Baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life - Core 30 (version 3). The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Change of EORTC QLQ-C30 at 12th week
Time frame: 12th week
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life - Core 30 (version 3) to 12th week. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Baseline QLQ-BR23
Time frame: Basline
Baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life - Breast 23 (version 3). The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Change of QLQ-BR23 at 12th week
Time frame: 12th week
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life - Breast 23 (version 3) to 12th week. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Baseline Mindful Attention Awareness Scale
Time frame: Basline
Baseline Mindful Attention Awareness Scale. Based on a mean of all items, MAAS scores can range from 1 to 6. Higher scores indicate greater mindfulness
Change of Mindful Attention Awareness Scale at 12th week
Time frame: 12th week
Change from baseline Mindful Attention Awareness Scale to 12th week. Based on a mean of all items, MAAS scores can range from 1 to 6. Higher scores indicate greater mindfulness
3 secondary outcomes
Baseline Physical Activity Scale
Time frame: Basline
Change of Physical Activity Scale at 12th week
Time frame: 12th week
Feasibility Test at 12th week
Time frame: 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Derived from this study: PubMed 40483151Yang YH, Chao YL, Lin YF, Liu PC, Chang KJ, Hou IC. Home-based remote dance program with biopsychosocial model improves quality of life in breast cancer patients: A randomized controlled trial. J Bodyw Mov Ther. 2025 Sep;43:376-385. doi: 10.1016/j.jbmt.2025.04.029. Epub 2025 Apr 17.
- 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. This study is not recruiting at the moment.
I-Ching Hou, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home_Based Digital Mindful Dance Program in people with Breast Cancer and Quality of Life, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jul 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Ching Hou, PhD (886-2-28267000 ext. 67315, evidta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline EORTC QLQ-C30 (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05938686, which also lists 1 linked publication.
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 10 Jul 2023.