Baduanjin Mind-Body Exercise for Cancer-Related Fatigue: Protocol for a Remotely Delivered Randomized Wait-List Controlled Feasibility Study

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
1 Chinese Medicine Centre (an international collaboration between Western Sydney University and Beijing University of Chinese Medicine), Western Sydney University, NSW, Australia.
2 School of Health Sciences, Western Sydney University, NSW, Australia.
3 Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.
4 Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, People's Republic of China.
5 Beijing University of Chinese Medicine, Beijing, People's Republic of China.
6 South Western Sydney Local Health District, Liverpool Hospital, NSW, Australia.
7 South Western Sydney Local Health District, Campbelltown Hospital, NSW, Australia.
8 University of Texas, MD Anderson Cancer Centre, Houston, TX, USA.
9 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

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.

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.

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