Clinical trial NCT06243107: Promoting the Application of Tai Chi to Improve the Fatigue in Cancer Patients
Official title: The Effectiveness of Tai-Chi in Cancer Patients Improves Fatigue, Mood, Sleep, Quality of Life and Heart Rate Variability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer
Fatigue
negative mood
quality of life
Sleeping quality
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental research
Primary purpose: TREATMENT

Brief summary: Cancer patients often experience Cancer-Related Fatigue (CRF) due to surgeries, radiation therapy, and/or chemotherapy. CRF does not improve with sleep or rest and not only affects daily activities but can also significantly reduce quality of life. Therefore, finding ways to alleviate fatigue is crucial for cancer patients. Literature indicates that exercise has demonstrated effectiveness in reducing fatigue. Qigong/Tai Chi, based on movement, is a traditional Chinese mind-body practice falling within the range of low to moderate-intensity aerobic exercise. There is no consistent consensus on the effectiveness and frequency of Qigong/Tai Chi for CRF in different cancer patients. Hence, this study aims to investigate through empirical nursing procedures whether "the practice of Qigong/Tai Chi by cancer patients can improve participants' fatigue. Researchers hope that the results of this study can serve as a reference for future clinical applications in alleviating fatigue among cancer patients.

Detailed description: Cancer has consistently ranked as the leading cause of death in Taiwan since 1982. Cancer patients undergo a series of medical treatments, including surgery, radiation therapy, and chemotherapy. Apart from the disease itself, the medical procedures associated with cancer often bring significant physiological, psychological, and emotional stress to the patients. Furthermore, Cancer-Related Fatigue (CRF) is the most common and persistent discomfort experienced by cancer patients. CRF is a prolonged subjective feeling of fatigue or exhaustion that does not improve with sleep or rest. Over 50% of cancer patients report that fatigue reduces participants' physical activity, affects participants ability to perform tasks, and disrupts participants' daily lives, ultimately leading to a diminished quality of life. Among non-pharmacological approaches to managing CRF, exercise has garnered the most research support and demonstrated efficacy. Despite potential limitations on exercise capacity due to the disease, studies have shown that patients, particularly during the initial diagnosis, surgery, or during radiation and chemotherapy, can alleviate CRF and improve participants' overall health through exercise.

Traditional Chinese Exercise and Health Preservation involves using techniques that regulate the mind, breath, and body to promote sufficient qi and blood circulation, unobstructed meridians, and harmonized organ functions. It is a traditional health preservation method aimed at enhancing physical fitness and preventing diseases. Tai Chi, a form of TCEHP, is simple to learn, with minimal space requirements. Through an evidence-based approach and a comprehensive review of two articles, it was found that intervention with Tai Chi for a duration of over 8 weeks, with at least 180 minutes per week, effectively alleviates fatigue in breast cancer and lung cancer patients. It also demonstrated positive effects on fatigue levels in head and neck cancer patients undergoing concurrent chemoradiotherapy (CCRT). Given our institution's diverse cancer patient population, primarily comprising head and neck, breast, and gastrointestinal cancer patients, Researchers plan to proceed with the fourth and fifth steps of the evidence-based practice to apply the evidence to patients and evaluate the care outcomes.

Therefore, the objectives of this study are as follows:

To promote the evidence-based application of Tai Chi for cancer patients to improve fatigue.To promote the evidence-based application of Tai Chi for cancer patients to improve sleep quality.

To promote the evidence-based application of Tai Chi for cancer patients to alleviate anxiety and depression.

To promote the evidence-based application of Tai Chi for cancer patients to enhance quality of life.

To promote the evidence-based application of Tai Chi for cancer patients to assess its impact on heart rate variability.

Eligibility criteria: Inclusion Criteria:

* Aged 20 years or older;
* Diagnosed with tumors and receiving radiation therapy, chemotherapy, or concurrent chemoradiotherapy.
* Able to communicate and cooperate with the executing team.
* Willing to participate in this study.

Exclusion Criteria:

* Diagnosed with severe internal medical conditions, multiple myeloma, or skeletal metastases.
* Evidence of medical contraindications for exercise.
* Regularly practicing health-preserving exercises or other forms of physical activity.
* Communication barriers, unable to cooperate with the execution of actions.

Primary outcomes:
measure: brief fatigue inventory
timeFrame: At enrollment, during the first week, second week, fourth week, and eighth week.
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: t enrollment, during the first week, second week, fourth week, and eighth week
measure: Hospital Anxiety and depression Scale
timeFrame: enrollment, during the first week, second week, fourth week, and eighth week
measure: FACIT-G quality of life
timeFrame: enrollment, during the first week, second week, fourth week, and eighth week
measure: Heart rate variability
timeFrame: enrollment, during the first week, second week, fourth week, and eighth week."
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
state: No.123,Dinghu Rd.,Guishan Dist
Study officials:
affiliation: Chang Gung Medical Foundation
name: Tsang-Tang MD Hsieh, PHD
role: STUDY_DIRECTOR
References:
citation: Wayne PM, Lee MS, Novakowski J, Osypiuk K, Ligibel J, Carlson LE, Song R. Tai Chi and Qigong for cancer-related symptoms and quality of life: a systematic review and meta-analysis. J Cancer Surviv. 2018 Apr;12(2):256-267. doi: 10.1007/s11764-017-0665-5. Epub 2017 Dec 8.
citation: Zeng Y, Xie X, Cheng ASK. Qigong or Tai Chi in Cancer Care: an Updated Systematic Review and Meta-analysis. Curr Oncol Rep. 2019 Apr 6;21(6):48. doi: 10.1007/s11912-019-0786-2.
citation: Li W, You F, Wang Q, Shen Y, Wang J, Guo J. Effects of Tai Chi Chuan training on the QoL and psychological well-being in female patients with breast cancer: a systematic review of randomized controlled trials. Front Oncol. 2023 May 1;13:1143674. doi: 10.3389/fonc.2023.1143674. eCollection 2023.
citation: Song S, Yu J, Ruan Y, Liu X, Xiu L, Yue X. Ameliorative effects of Tai Chi on cancer-related fatigue: a meta-analysis of randomized controlled trials. Support Care Cancer. 2018 Jul;26(7):2091-2102. doi: 10.1007/s00520-018-4136-y. Epub 2018 Mar 21.