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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Breast Cancer; Intraoperative Awareness
• Intervention / Treatment: Other: qigong

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Chang Gung University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: qigong group; 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).	Other: qigong; Chan-Chuang qigong with breathing meditation for 15 weeks
NO_INTERVENTION: control group; those in the control group received usual care during the same study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Collaborators and Investigators

• Sponsor: Ching-I Chang
• Collaborators: Taipei Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 25, 2017
• Primary Completion (ACTUAL): October 22, 2021
• Study Completion (ACTUAL): October 22, 2021

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (ACTUAL): May 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Intraoperative Complications; Breast Neoplasms; Intraoperative Awareness
• Other Study ID Numbers: TCHIRB-10601103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No