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Completed

NCT Number: NCT05385146

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Intraoperative Awareness Intraoperative Complications Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University of Science and Technology

Taoyuan, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Qigong

Other

Chan-Chuang qigong with breathing meditation for 15 weeks

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Ching-I Chang

Other

Collaborators

  • Taipei Hospital, Taiwan

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 23, 2022
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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