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Effect of Chan-Chuang Qigong With Breathing Meditation on Quality of Life in Patients With Breast Cancer

Primary Purpose

Breast Cancer, Quality of Life, Intraoperative Awareness

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
qigong
Sponsored by
Ching-I Chang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. aged ≥20
  2. diagnosed with breast cancer (stages I and II)
  3. before receiving chemotherapy
  4. conscious clear to communicate.

Exclusion Criteria:

  1. severe cardiopulmonary, liver or kidney dysfunction
  2. the original law of qigong cases.

Sites / Locations

  • Chang Gung University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

qigong group

control group

Arm Description

The qigong group received Chan-Chuang qigong therapy with breathing meditation for 15 weeks.Qigong training program consisted of a warm-up, Chan-Chuang qigong, and breathing meditation. The whole process takes about 20 minutes.The qigong was monitored in terms of muscle elasticity and heart rate variability. After practicing the Chan-Chuang qigong, meditation with breathing was conducted for 10 minutes. In the meanwhile, sit down while relaxing with slow breathing and focus on the present feelings, with brain wave (NeuroSky's, Australia) to monitor and confirm that the eSense (attention and relaxation).

those in the control group received usual care during the same study period.

Outcomes

Primary Outcome Measures

Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30) scores
Quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).It consists of 30 items to measure multiple aspects that incorporated five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and six single common items (dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties). The scoring system ranged from 1 (not at all) to 4 (very much). High scores for functional items and low scores for symptoms represent the good QoL.There are two questions for the overall quality of life rating, and the ranking ranged from 1 (very poor) to 7 (excellent).
Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-C) scores
Interoceptive Awareness was assessed using the Chinese version of the Multidimensional Assessment of Interoceptive Awareness (MAIA-C). which adopts the systematic development of a self-filled questionnaire for the research of experiencing inner perception and the assessment of the physical and mental activity. A total of 32 questions were divided into eight dimensions: Noticing, Not distracting, Not worrying, Attention regulation, Emotional awareness, Self-Regulation, Body listening, and Trusting. The scale asks the individual to answer questions about their inner perception and circle the number that best suits their feelings. The answer options for each question ranged between 0 (never) and 5 (always). The higher scores indicating more positively appraised interoceptive awareness.

Secondary Outcome Measures

Full Information

First Posted
April 29, 2022
Last Updated
May 19, 2022
Sponsor
Ching-I Chang
Collaborators
Taipei Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05385146
Brief Title
Effect of Chan-Chuang Qigong With Breathing Meditation on Quality of Life in Patients With Breast Cancer
Official Title
Effect of Chan-Chuang Qigong With Breathing Meditation on Quality of Life in Patients With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 25, 2017 (Actual)
Primary Completion Date
October 22, 2021 (Actual)
Study Completion Date
October 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ching-I Chang
Collaborators
Taipei Hospital, Taiwan

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
The aim of this study was to evaluate the effect of the 15 weeks Chan-Chuang qigong program with breathing meditation on quality of life and interoceptive awareness in patients with breast cancer during chemotherapy.
Detailed Description
Cancer is the leading cause of death globally, and breast cancer is the number one threat to women's health worldwide. Chemotherapy is the main adjunctive treatment for breast cancer. However, chemotherapy increasingly being employed in the management of breast cancer patients will cause physical and psychological discomfort as reported. The aim of this study was to evaluate the effect of Chan-Chuang qigong therapy with breathing meditation on quality of life and interoceptive awareness in breast cancer patients. This was a randomized controlled trial. Participants were randomly assigned to the qigong group who received Chan-Chuang qigong therapy with breathing meditation for 15 weeks, and the control group who received routine care. The outcomes were measured by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Multidimensional Assessment of Interoceptive Awareness (MAIA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Quality of Life, Intraoperative Awareness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized
Masking
None (Open Label)
Masking Description
patients who signed inform consent are randomized into qigong group and control group
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
qigong group
Arm Type
Experimental
Arm Description
The qigong group received Chan-Chuang qigong therapy with breathing meditation for 15 weeks.Qigong training program consisted of a warm-up, Chan-Chuang qigong, and breathing meditation. The whole process takes about 20 minutes.The qigong was monitored in terms of muscle elasticity and heart rate variability. After practicing the Chan-Chuang qigong, meditation with breathing was conducted for 10 minutes. In the meanwhile, sit down while relaxing with slow breathing and focus on the present feelings, with brain wave (NeuroSky's, Australia) to monitor and confirm that the eSense (attention and relaxation).
Arm Title
control group
Arm Type
No Intervention
Arm Description
those in the control group received usual care during the same study period.
Intervention Type
Other
Intervention Name(s)
qigong
Intervention Description
Chan-Chuang qigong with breathing meditation for 15 weeks
Primary Outcome Measure Information:
Title
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30) scores
Description
Quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).It consists of 30 items to measure multiple aspects that incorporated five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and six single common items (dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties). The scoring system ranged from 1 (not at all) to 4 (very much). High scores for functional items and low scores for symptoms represent the good QoL.There are two questions for the overall quality of life rating, and the ranking ranged from 1 (very poor) to 7 (excellent).
Time Frame
baseline, Week 6, Week 15.
Title
Change in Multidimensional Assessment of Interoceptive Awareness (MAIA-C) scores
Description
Interoceptive Awareness was assessed using the Chinese version of the Multidimensional Assessment of Interoceptive Awareness (MAIA-C). which adopts the systematic development of a self-filled questionnaire for the research of experiencing inner perception and the assessment of the physical and mental activity. A total of 32 questions were divided into eight dimensions: Noticing, Not distracting, Not worrying, Attention regulation, Emotional awareness, Self-Regulation, Body listening, and Trusting. The scale asks the individual to answer questions about their inner perception and circle the number that best suits their feelings. The answer options for each question ranged between 0 (never) and 5 (always). The higher scores indicating more positively appraised interoceptive awareness.
Time Frame
baseline, Week 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged ≥20 diagnosed with breast cancer (stages I and II) before receiving chemotherapy conscious clear to communicate. Exclusion Criteria: severe cardiopulmonary, liver or kidney dysfunction the original law of qigong cases.
Facility Information:
Facility Name
Chang Gung University of Science and Technology
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Chan-Chuang Qigong With Breathing Meditation on Quality of Life in Patients With Breast Cancer

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