Abstract
Introduction: The fatigue-sleep disturbance-depression symptom cluster (FSDSC) is one of the most common and debilitating side effects in breast cancer (BC) patients throughout their treatment trajectory. Tai chi has been supported as a promising non-pharmacological intervention for the individual symptom relief of cancer-related fatigue, sleep disturbance, and depression. However, relevant evidence of using tai chi for FSDSC management in BC patients has been lacking.
Methods: This study will be a two-arm, single-blinded pilot randomized controlled trial (RCT) involving an 8-week intervention and a 4-week follow-up. Seventy-two BC patients experiencing the FSDSC will be recruited from two tertiary medical centres in China. The participants will be randomized to either a tai chi group (n=36) or a control group (n=36). The participants in the tai chi group will receive an 8-week tai chi intervention in addition to standard care, while the participants in the control group will receive standard care only consisting of a booklet on the self-management of cancer symptoms. The primary outcomes will include a series of feasibility assessments of the study protocol in relation to the study’s methodological procedures, including subject recruitment and follow-up process, completion of study questionnaires, and the feasibility, acceptability, and safety of the intervention. The secondary outcomes will be the clinical outcomes regarding the effects of tai chi on the FSDSC and quality of life, which will be evaluated by the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaires.
Methods: This study will be a two-arm, single-blinded pilot randomized controlled trial (RCT) involving an 8-week intervention and a 4-week follow-up. Seventy-two BC patients experiencing the FSDSC will be recruited from two tertiary medical centres in China. The participants will be randomized to either a tai chi group (n=36) or a control group (n=36). The participants in the tai chi group will receive an 8-week tai chi intervention in addition to standard care, while the participants in the control group will receive standard care only consisting of a booklet on the self-management of cancer symptoms. The primary outcomes will include a series of feasibility assessments of the study protocol in relation to the study’s methodological procedures, including subject recruitment and follow-up process, completion of study questionnaires, and the feasibility, acceptability, and safety of the intervention. The secondary outcomes will be the clinical outcomes regarding the effects of tai chi on the FSDSC and quality of life, which will be evaluated by the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaires.
| Original language | English |
|---|---|
| Article number | e048115 |
| Number of pages | 8 |
| Journal | BMJ Open |
| Volume | 11 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - 18 Aug 2021 |
Bibliographical note
Funding Information:Funding This trial was funded by the Australian Government Research Training Programme (RTP) scholarship, and the Award/Grant number is not applicable.The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Publisher Copyright:
© Authors 2021
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
