Breast CancerNCT05385146
Effect of Chan-Chuang Qigong With Breathing Meditation on Quality of Life in Patients With Breast Cancer
A study testing qigong in people with Breast Cancer and Quality of Life, run by Ching-I Chang at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer, Quality of Life, Intraoperative Awareness
- What is being tested?
- qigong
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Dec 2017to 22 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥20
- diagnosed with breast cancer (stages I and II)
- before receiving chemotherapy
- conscious clear to communicate.
Who cannot join
- severe cardiopulmonary, liver or kidney dysfunction
- the original law of qigong cases.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Breast Cancer, Quality of Life, Intraoperative Awareness
- Being tested
- qigong
- Medical subject headings
- Breast Neoplasms, Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qigongOther
Chan-Chuang qigong with breathing meditation for 15 weeks
| Study group | Role | What they receive |
|---|---|---|
| qigong group | Experimental | 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). Receives: Other: qigong |
| control group | No intervention | those in the control group received usual care during the same study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: baseline, Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start25 Dec 2017
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ching-I Chang
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Hospital, Taiwan
- Responsible party
- Sponsor-investigator, Ching-I Chang, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385146
- Sponsor's protocol ID
- TCHIRB-10601103
- Status last verified
- May 2022
- First submitted
- 29 Apr 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang CI, Yeh ML, Liao J. Chan-Chuang qigong with breathing meditation improves quality of life and interoceptive awareness in patients with breast cancer: a randomised controlled trial. Support Care Cancer. 2023 Jan 28;31(2):140. doi: 10.1007/s00520-023-07578-w.
PubMed 36707489
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chan-Chuang Qigong With Breathing Meditation on Quality of Life in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT05385146
- Acronym / sponsor ID
- TCHIRB-10601103
- Conditions
- Breast Cancer, Quality of Life, Intraoperative Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ching-I ChangUniversity, hospital or other
- Collaborators
- Taipei Hospital, Taiwan
- Study start
- 25 Dec 2017 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized
| Arm | Type | Receives |
|---|---|---|
| qigong group | Experimental | Other: qigongThe 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). |
| control group | No intervention | –those in the control group received usual care during the same study period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged ≥20
- diagnosed with breast cancer (stages I and II)
- before receiving chemotherapy
- conscious clear to communicate.
Key exclusion criteria (2 listed)
- severe cardiopulmonary, liver or kidney dysfunction
- the original law of qigong cases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qigongChan-Chuang qigong with breathing meditation for 15 weeks | Other | qigong group |
Primary outcome
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30) scores
Time frame: baseline, Week 6, Week 15.
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
Time frame: baseline, Week 15
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 36707489Chang CI, Yeh ML, Liao J. Chan-Chuang qigong with breathing meditation improves quality of life and interoceptive awareness in patients with breast cancer: a randomised controlled trial. Support Care Cancer. 2023 Jan 28;31(2):140. doi: 10.1007/s00520-023-07578-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing qigong in people with Breast Cancer and Quality of Life, run by Ching-I Chang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30) scores (time frame: baseline, Week 6, Week 15.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05385146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.