Effects of Sitting Baduanjin on Cancer-Related Fatigue in Patients With Advanced Cancer: Protocol for a Randomized Controlled Trial

坐八段锦对晚期癌症患者癌症相关疲劳的影响:一项随机对照试验方案

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Abstract

BACKGROUND: Approximately 60% of patients with advanced cancer experience the distress of cancer-related fatigue (CRF), which significantly worsens their daily function and quality of life. Baduanjin has been regarded as a promising nonpharmacological intervention for alleviating CRF, anxiety, and depression and improving quality of life. Owing to varying degrees of CRF in patients with advanced cancer, patients may have insufficient endurance, making it difficult to implement standing Baduanjin. However, relevant evidence on sitting Baduanjin for CRF in patients with advanced cancer is lacking. OBJECTIVE: This study aims to design a sitting Baduanjin intervention and explore the efficacy and safety of sitting Baduanjin in reducing CRF among patients with advanced cancer. METHODS: This study will be a single-blind pilot randomized controlled trial. Patients with CRF will be enlisted from a tertiary cancer hospital in China. The participants (N=98) will be randomly assigned to either a sitting Baduanjin group or a control group at a 1:1 ratio using a block-randomized scheme. The participants in the sitting Baduanjin group will undergo a 16-week sitting Baduanjin intervention in addition to standard care, whereas the participants in the control group will receive standard care in the form of a booklet on the self-management of cancer symptoms. CRF will constitute the primary outcome, whereas anxiety, depression, and quality of life will serve as the secondary outcomes. These outcomes will be assessed at baseline (T0), 12 weeks (T1), and 16 weeks (T2). RESULTS: The study was approved by the Medical Ethics Review Committee of Hunan Cancer Hospital in March 2024 (ethics approval number 2024.50). Before this full-scale randomized controlled trial, we conducted a pilot study, which demonstrated the feasibility and acceptability of sitting Baduanjin for patients with advanced cancer, with potential benefits for relieving fatigue. CONCLUSIONS: This randomized trial will evaluate the effectiveness of sitting Baduanjin exercises in alleviating CRF among patients with advanced cancer. If proven effective, it will provide a promising alternative intervention for patients with advanced cancer.

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