Home_Based Digital Mindful Dance Program for Breast Cancer Cases

Breast Cancer Clinical Trial

— Dance4BC  

Official title:

Home_Based Digital Mindful Dance Program for Breast Cancer Cases: Feasibility, Body-Mind Awareness and Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938686
• Other study ID #: NYCU112051AEF
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: National Yang Ming University
• Contact: I-Ching Hou, PhD
• Phone: 886-2-28267000
• Email: evidta[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• breast cancer with any stage and any treatment status

Exclusion Criteria:

• mental illness

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	12th week
Primary	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.	Basline
Primary	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.	12th week
Primary	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	Basline
Primary	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	12th week
Secondary	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.	Basline
Secondary	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.	12th week
Secondary	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.	12th week