Home_Based Digital Mindful Dance Program for Breast Cancer Cases

NCT05938686 | Unknown DMC

• 1 other identifier: NYCU112051AEF
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Quality of Life

Keywords

breast cancer; mindfulness; dance; home based digitalization; quality of life

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Baseline Physical Activity Scale

  Basline

• Change of Physical Activity Scale at 12th week

  12th week

• Feasibility Test at 12th week

  12th week

Study Arms (2)

Interventional Group

EXPERIMENTAL

Home\_Based Digital Mindful Dance Program for 12 weeks

Other: Home_Based Digital Mindful Dance Program

Control Group

NO INTERVENTION

Routine care for 12 weeks.

Interventions

Home_Based Digital Mindful Dance Program OTHER

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

Interventional Group

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: more than 20 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• breast cancer with any stage and any treatment status

You may not qualify if:

• mental illness

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming University

Taipei, 11221, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• I-Ching Hou, PhD

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Ching Hou, PhD

CONTACT

886-2-28267000; evidta@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 10, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)