Abstract
Purpose: Fatigue-sleep disturbance-depression symptom cluster (FSDSC) is the most common symptom cluster experienced by breast cancer patients during cancer therapy, frequently results in poor quality of life and reduced daily functioning. A mount of research demonstrated that tai chi is a beneficial non-pharmacological approach for single symptom management of fatigue, sleep disturbance and depression in cancer patients. To date, tai chi has not been conducted in breast cancer patients with the FSDSC and the potential benefits of tai chi has not been explored. Thus, a pilot study will be conducted to test the feasibility and preliminary effects of tai chi in BC patients with FSDSC.
Methods:A single-blinded, parallel randomized controlled pilot trial is conducted in two tertiary medical centers in China. A total of 72 breast cancer participants with the FSDSC will be randomly assigned to either a control group or a tai chi group in a 1:1 ratio. Participants in the tai chi group will receive tai chi practicing at a frequency of 60 min per time, 2 times per week for 8 weeks in addition to the routine methods of treatment and care. Participants in the control group will receive the routine methods of treatment and care only. The feasibility and acceptability outcomes, including the feasibility of recruitment and the follow-up process, questionnaires, the intervention, and the safety outcomes, will be the primary outcomes. The clinical outcomes, including the Brief Fatigue Inventory, Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, and the Functional Assessment of Cancer Therapy-Breast questionnaires, will be the secondary outcomes. All the outcomes will be assessed at three time points: baseline measurement at recruitment, right after the intervention, and four weeks after completion of the intervention. This study has been registered at the ClinicalTrials.gov (identifier NCT04190342). The study has received ethical approval from Charles Darwin University and the study sites.
Results: The clinical trial is still ongoing, and the data collection is expected to be finalized by March, 2021.
Conclusion: This is a first study to examine the feasibility and preliminary effects of tai chi on the FSDSC in breast cancer patients. The findings of this pilot study will provide significant knowledge and evidence base in FSDSC management and will contribute to a future multicentre large-scale main RCT to further conclude the research evidence on the effects and safety of tai chi on the FSDSC management in breast cancer patients.
Methods:A single-blinded, parallel randomized controlled pilot trial is conducted in two tertiary medical centers in China. A total of 72 breast cancer participants with the FSDSC will be randomly assigned to either a control group or a tai chi group in a 1:1 ratio. Participants in the tai chi group will receive tai chi practicing at a frequency of 60 min per time, 2 times per week for 8 weeks in addition to the routine methods of treatment and care. Participants in the control group will receive the routine methods of treatment and care only. The feasibility and acceptability outcomes, including the feasibility of recruitment and the follow-up process, questionnaires, the intervention, and the safety outcomes, will be the primary outcomes. The clinical outcomes, including the Brief Fatigue Inventory, Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, and the Functional Assessment of Cancer Therapy-Breast questionnaires, will be the secondary outcomes. All the outcomes will be assessed at three time points: baseline measurement at recruitment, right after the intervention, and four weeks after completion of the intervention. This study has been registered at the ClinicalTrials.gov (identifier NCT04190342). The study has received ethical approval from Charles Darwin University and the study sites.
Results: The clinical trial is still ongoing, and the data collection is expected to be finalized by March, 2021.
Conclusion: This is a first study to examine the feasibility and preliminary effects of tai chi on the FSDSC in breast cancer patients. The findings of this pilot study will provide significant knowledge and evidence base in FSDSC management and will contribute to a future multicentre large-scale main RCT to further conclude the research evidence on the effects and safety of tai chi on the FSDSC management in breast cancer patients.
| Original language | English |
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| Publication status | Published - 21 Jul 2021 |
| Event | 32nd International Nursing Research Congress, Honor Society of Nursing, The Sigma Theta Tau International - Online Duration: 21 Jul 2021 → 23 Jul 2021 https://stti.confex.com/stti/congrs21/meetingapp.cgi/Home/0 |
Conference
| Conference | 32nd International Nursing Research Congress, Honor Society of Nursing, The Sigma Theta Tau International |
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| Period | 21/07/21 → 23/07/21 |
| Internet address |
