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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05385146
Other study ID # TCHIRB-10601103
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 25, 2017
Est. completion date October 22, 2021

Study information

Verified date May 2022
Source Chang Gung University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 22, 2021
Est. primary completion date October 22, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Intervention

Other:
qigong
Chan-Chuang qigong with breathing meditation for 15 weeks

Locations

Country Name City State
Taiwan Chang Gung University of Science and Technology Taoyuan

Sponsors (2)

Lead Sponsor Collaborator
Ching-I Chang Taipei Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). baseline, Week 6, Week 15.
Primary 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. baseline, Week 15
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