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Home_Based Digital Mindful Dance Program for Breast Cancer Cases (Dance4BC)

Primary Purpose

Breast Cancer, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Home_Based Digital Mindful Dance Program
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring breast cancer, mindfulness, dance, home based digitalization, quality of life

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: breast cancer with any stage and any treatment status Exclusion Criteria: mental illness

Sites / Locations

  • National Yang-Ming UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional Group

Control Group

Arm Description

Home_Based Digital Mindful Dance Program for 12 weeks

Routine care for 12 weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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
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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 29, 2023
Last Updated
July 6, 2023
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT05938686
Brief Title
Home_Based Digital Mindful Dance Program for Breast Cancer Cases
Acronym
Dance4BC
Official Title
Home_Based Digital Mindful Dance Program for Breast Cancer Cases: Feasibility, Body-Mind Awareness and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Quality of Life
Keywords
breast cancer, mindfulness, dance, home based digitalization, quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
Home_Based Digital Mindful Dance Program for 12 weeks
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Routine care for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Home_Based Digital Mindful Dance Program
Intervention Description
Home_Based Digital Mindful Dance Program including warm up, dance and cool down for 60 minute with 12 weeks.
Primary Outcome Measure Information:
Title
Baseline EORTC QLQ-C30
Description
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
Title
Change of EORTC QLQ-C30 at 12th week
Description
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
Title
Baseline QLQ-BR23
Description
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
Title
Change of QLQ-BR23 at 12th week
Description
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
Title
Baseline Mindful Attention Awareness Scale
Description
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
Title
Change of Mindful Attention Awareness Scale at 12th week
Description
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 Outcome Measure Information:
Title
Baseline Physical Activity Scale
Description
Baseline Physical Activity Scale. The minimum and maximum values are 1 and 4, and higher scores mean a better physical activity.
Time Frame
Basline
Title
Change of Physical Activity Scale at 12th week
Description
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
Title
Feasibility Test at 12th week
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
more than 20 years old
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: breast cancer with any stage and any treatment status Exclusion Criteria: mental illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I-Ching Hou, PhD
Phone
886-2-28267000
Ext
67315
Email
evidta@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Ching Hou, PhD
Organizational Affiliation
National Yang Ming Chiao Tung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
11221
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IChing Hou, PhD
Phone
886-2-28267000
Ext
7315
Email
evita@ym.edu.tw
First Name & Middle Initial & Last Name & Degree
IChing Hou, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Home_Based Digital Mindful Dance Program for Breast Cancer Cases

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