Cancer Clinical Trial
Official title:
The Effectiveness of Tai-Chi in Cancer Patients Improves Fatigue, Mood, Sleep, Quality of Life and Heart Rate Variability
NCT number | NCT06243107 |
Other study ID # | 201900504B0 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | June 30, 2022 |
Verified date | October 2023 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taoyuan Chang Gung Memorial Hospital | Taoyuan | No.123,Dinghu Rd.,Guishan Dist |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
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
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." |
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