Author: Sean Walsh1,2, Kang Wang1,3, Anderson Lam1, Shihao Du1,4, Yanbin Hu1,5, Yu-Ting Sun1,2, Elise Tcharkhedian6, Evangeline Nikas6, Gregory Webb6,7, Eugene Moylan6, Stephen Della-Fiorentina6,7, Paul Fahey2, Xin Shelley Wang8, Ming Chen1,9, Xiaoshu Zhu1,2
Affiliation: <sup>1</sup> Chinese Medicine Centre (an international collaboration between Western Sydney University and Beijing University of Chinese Medicine), Western Sydney University, NSW, Australia.
<sup>2</sup> School of Health Sciences, Western Sydney University, NSW, Australia.
<sup>3</sup> Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.
<sup>4</sup> Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, People's Republic of China.
<sup>5</sup> Beijing University of Chinese Medicine, Beijing, People's Republic of China.
<sup>6</sup> South Western Sydney Local Health District, Liverpool Hospital, NSW, Australia.
<sup>7</sup> South Western Sydney Local Health District, Campbelltown Hospital, NSW, Australia.
<sup>8</sup> University of Texas, MD Anderson Cancer Centre, Houston, TX, USA.
<sup>9</sup> Guizhou University of Traditional Chinese Medicine, Guiyang, People's Republic of China.
Conference/Journal: Integr Cancer Ther
Date published: 2024 Jan-Dec
Other:
Volume ID: 23 , Pages: 15347354231226127 , Special Notes: doi: 10.1177/15347354231226127. , Word Count: 278
Background:
People living with a cancer diagnosis often experience cancer-related fatigue (CRF). Between 9% and 45% of people report CRF as moderate to severe, negatively impacting their quality-of-life (QOL). The evidence-base for managing CRF recommends exercise-related therapies over pharmaceutical interventions. One such exercise-like therapy is Baduanjin mind-body exercise (MBE), which has additional benefits. A remotely delivered program may further benefit people with CRF. The primary objective of this pilot will test study feasibility of a remotely delivered Baduanjin MBE exercise program for people living with CRF.
Methods:
This is a randomized wait-list controlled pilot study and will take place in Sydney, Australia. Subject to informed consent, 40 adults with moderate CRF levels and receiving or previously received adjuvant chemotherapy, will undertake a home-based 8-week Baduanjin MBE program supported by online resources and instructors. The primary feasibility outcomes are recruitment, enrollment, retention, and adherence rates; and safety as measured by tolerance and adverse-event frequency. Clinical outcomes (eg, changes in CRF, QOL, and participant perceptions) are assessed at pre-intervention, week 1, week 4, week 8, and post-intervention. Analyses follows the Intent-to-Treat (all participants as per randomization) and per-protocol (participants adhering to the protocol). Missing data will be imputed from previous data entries and regression models may be tested to predict missing outcomes.
Discussion:
To our knowledge, this is the first study evaluating the feasibility and effects of Baduanjin MBE on CRF using a remote delivery method. These feasibility data will inform a fully powered future trial investigating evidence of effect on CRF and QOL.Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTR 12623000177651).Ringgold ID: 651498 Chinese Medicine Centre.
Keywords: Baduanjin Qigong; cancer-related fatigue; randomized clinical trial feasibility protocol; remote intervention delivery; traditional medicine.
PMID: 38317410 DOI: 10.1177/15347354231226127