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RecruitingNCT05938686Dance4BCUpdated Jul 10, 2023

Home_Based Digital Mindful Dance Program for Breast Cancer Cases

An interventional study of Home_Based Digital Mindful Dance Program in Breast Cancer and Quality of Life, sponsored by National Yang Ming Chiao Tung University. Recruiting at 1 site in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-07-10.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
20 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Breast Cancer
  • Quality of Life

Browse trials for

Keywords

  • breast cancer
  • mindfulness
  • dance
  • home based digitalization
  • quality of life
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 104 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • breast cancer with any stage and any treatment status

Exclusion criteria

Exclusion Criteria:

  • mental illness
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    Interventional Group

    Home_Based Digital Mindful Dance Program for 12 weeks

    Other: Home_Based Digital Mindful Dance Program

  • No intervention
    Control Group

    Routine care for 12 weeks.

Interventions

  • OtherHome_Based Digital Mindful Dance Program

    Home_Based Digital Mindful Dance Program including warm up, dance and cool down for 60 minute with 12 weeks.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: 12th week

  3. 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.

    Time frame: Basline

  4. 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.

    Time frame: 12th week

  5. 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

    Time frame: Basline

  6. 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

    Time frame: 12th week

Secondary outcomes

  1. 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.

    Time frame: Basline

  2. 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.

    Time frame: 12th week

  3. 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.

    Time frame: 12th week

07

Study locations

1 of 1 sites recruiting
  • National Yang-Ming University
    Taipei, 11221, Taiwan
    • IChing Hou, PhD · Contact · evita@ym.edu.tw · 886-2-28267000
    • IChing Hou, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05938686
Lead sponsor
National Yang Ming Chiao Tung University
Responsible party
I-Ching Hou (Associate Professor, National Yang Ming Chiao Tung University) — Principal investigator
First posted
Jul 10, 2023
Start date
Jul 1, 2023
Primary completion
Jun 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jul 10, 2023

Study contacts

I-Ching Hou, PhD
Contact
evidta@gmail.com
886-2-28267000 ext. 67315
I-Ching Hou, PhD
principal investigator · National Yang Ming Chiao Tung University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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