NCT05385146

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

3.8 years

First QC Date

April 29, 2022

Last Update Submit

May 19, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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).

Other: qigong

control group

NO INTERVENTION

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

Interventions

qigongOTHER

Chan-Chuang qigong with breathing meditation for 15 weeks

qigong group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University of Science and Technology

Taoyuan District, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast NeoplasmsIntraoperative Awareness

Interventions

Qigong

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
patients who signed inform consent are randomized into qigong group and control group
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 23, 2022

Study Start

December 25, 2017

Primary Completion

October 22, 2021

Study Completion

October 22, 2021

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations