Promoting the Application of Tai Chi to Improve the Fatigue in Cancer Patients

Cancer Clinical Trial

Official title:

The Effectiveness of Tai-Chi in Cancer Patients Improves Fatigue, Mood, Sleep, Quality of Life and Heart Rate Variability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06243107
• Other study ID #: 201900504B0
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Fatigue

Intervention

Behavioral:
• Tai-chi
Participants will each receive a Tai Chi manual and have access to an instructional audio-visual material via a QR code. The instructional material is tailored specifically for cancer patients. Participants will receive individualized guidance and instructions from the researcher (YH) until they have completed all the executions on the checklist to the required standards.

Locations

Country	Name	City	State
Taiwan	Taoyuan Chang Gung Memorial Hospital	Taoyuan	No.123,Dinghu Rd.,Guishan Dist

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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: 10.3 — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brief fatigue inventory	Mendoza et al. developed the Brief Fatigue Inventory (BFI) in 1999 to rapidly assess the level of fatigue in cancer patients. This scale comprises nine questions. The first three questions assess the level of fatigue, including current fatigue, typical fatigue over the past 24 hours, and worst fatigue over the past 24 hours. The remaining six questions assess the impact of fatigue on daily life over the past 24 hours, covering general activities, mood, walking ability, daily work (including work outside the home and household chores), interaction with others, and enjoyment of life. Scores range from 0 to 10, where 0 indicates no fatigue, and 10 represents the worst imaginable level of fatigue. The scores for the nine questions are then summed and averaged, with higher scores indicating higher levels of fatigue and a more significant impact on daily life.; Regenerate	At enrollment, during the first week, second week, fourth week, and eighth week.
Secondary	Pittsburgh Sleep Quality Index	This scale, developed by Buysse et al. in 1989, is a self-administered questionnaire used to assess the sleep patterns of respondents over the past month. The scale consists of seven monitoring items, including sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each item is rated on a four-point Likert scale. The questionnaire score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality. A PSQI score greater than 5 indicates poor sleep quality. The scale has been translated into Chinese by Wang Runqing. The English version demonstrates a Cronbach's alpha reliability coefficient of .75."	t enrollment, during the first week, second week, fourth week, and eighth week
Secondary	Hospital Anxiety and depression Scale	This scale, developed by Zigmond and Snaith (1983), is primarily designed to measure anxiety and depression in general clinical populations for assessing the severity of emotional disorders. The Hospital Anxiety and Depression Scale (HADS) utilizes a 4-point scoring system, separate scoring for anxiety and depression, and consists of a total of 14 items, with 7 assessing anxiety and 7 assessing depression. The scores for both domains range from 0 to 21 points. Scores less than 7 indicate the absence of anxiety or depression. Scores between 8 and 10 suggest borderline or suspected cases. Scores equal to or greater than 11 indicate the presence of anxiety or depression. This scale is frequently used in research involving cancer patients. The internal consistency reliability for this scale, measured using Cronbach's alpha, is 0.85 for anxiety and 0.81 for depression."; Regenerate	enrollment, during the first week, second week, fourth week, and eighth week
Secondary	FACIT-G quality of life	"This study utilized the FACIT-G scale for self-reporting and design, although it can also be administered through interviews. The scale is structured around four factors: 'Physical Well-being,' 'Social/Family Well-being,' 'Functional Well-being,' and 'Emotional Well-being.' The scale includes two subscales, 'Emotional Well-being' and 'Social/Family Well-being,' and all subscale items contribute to the total score, which represents the sum of subscale scores. For all FACIT scales and symptom indices, a higher score indicates a better quality of life. The Cronbach's alpha for the entire range is 0.89	enrollment, during the first week, second week, fourth week, and eighth week
Secondary	Heart rate variability	The study utilized a Heart Rate Variability (HRV) monitor (Model: 8Z11, WeGene Corporation, Ministry of Health and Welfare Medical Equipment No. 004896, Taiwan) to measure HRV parameters. This device measures and records electrocardiograms, and calculates heart rate, standard deviation, and mean value using each RR interval. Subsequently, it performs frequency domain analysis to derive HRV parameters, including standard deviation of normal-to-normal intervals, low-frequency power, high-frequency power, and the ratio of low-frequency to high-frequency power.	enrollment, during the first week, second week, fourth week, and eighth week."