Oncology · Medical Literature
Codesign and implementation of a Tai Chi intervention for managing the fatigue, sleep disturbance and depression symptom cluster in breast cancer survivors in regional Australia: a feasibility study protocol
Abstract
Introduction Breast cancer survivors (BCS) often experience side effects such as the fatigue, sleep disturbance and depression symptom cluster (FSDSC). Previous studies have demonstrated the potential efficacy of Tai Chi (TC) for improving FSDSC in BCS in a hospital setting in China. This study will explore the feasibility, acceptability and preliminary effects of the Easy 8 Form TC protocol as an adjuvant therapy in BC survivorship care, adapted to a regional Australian community setting. Methods and analysis The purpose of the present study is to provide a codesigned TC protocol. This multimethod study comprises a codesign study, followed by a pilot study of the adapted TC protocol. In stage 1, women with lived experience of breast cancer and community-based healthcare providers will be involved with the codesign study. The transcripts from the focus group, interviews and workshop will be thematically analysed to inform adaptations to the TC protocol to fit into the local primary health sector. Stage 2 will be a small prospective pilot study with a group of BCS trialling the adapted TC intervention. The primary outcomes of the trial are the feasibility and acceptability of TC for BCS. The secondary outcomes are clinical measures of fatigue, sleep disturbance, depression and quality of life, which will be collected from the participants of the pilot study for pre-post comparison. The findings from this study will inform stakeholder participation in codesign research with BCS. The findings will also benefit further iterations of the TC intervention, as future research continues exploring the health effects of TC. Ethics and dissemination Ethical approval was granted by Charles Darwin University Human Research Ethics Committee. Results will be reported in the trial registry and disseminated to participants via a peer-reviewed journal. Trial registration number ACTRN12626000050358 Australian New Zealand Clinical Trials Registry.
Clinical relevance
Breast cancer survivors (BCS) frequently experience the fatigue, sleep disturbance, and depression symptom cluster (FSDSC), a co-occurring and clinically burdensome triad that significantly impairs quality of life during survivorship. Existing evidence for Tai Chi (TC) as a non-pharmacological adjuvant therapy derives predominantly from hospital-based studies in China, leaving a critical gap regarding its feasibility and cultural adaptability in community settings in Western, regional populations. This protocol addresses that gap by codesigning a contextually adapted TC intervention for BCS in regional Australia, where access to specialist survivorship care is often limited.
Key findings
1. This is a feasibility and acceptability study protocol — no efficacy outcome data are yet reported; quantitative effect sizes, confidence intervals, p-values, and NNT/NNH are not available at this stage of the research program. 2. The intervention under investigation is the 'Easy 8 Form' Tai Chi protocol, selected as a simplified, accessible TC style suited to community-based delivery for BCS. 3. The study employs a multimethod, two-stage design: Stage 1 is a qualitative codesign phase involving BCS with lived experience and community-based healthcare providers (focus groups, interviews, and workshops); Stage 2 is a small prospective pre-post pilot trial of the adapted TC protocol. 4. Primary outcomes are feasibility and acceptability of the TC intervention in a regional Australian primary healthcare context; secondary outcomes include validated clinical measures of fatigue, sleep disturbance, depression, and health-related quality of life, assessed via pre-post comparison. 5. The codesign methodology explicitly incorporates patient and community stakeholder input to adapt the TC protocol from its original hospital-based Chinese context to regional Australian primary care, addressing both cultural and logistical transferability. 6. Ethical approval was granted by Charles Darwin University Human Research Ethics Committee, and the trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12626000050358), confirming procedural rigor appropriate for a feasibility protocol.
Practice implications
Clinicians managing BCS in regional or resource-limited settings should be aware that community-delivered Tai Chi — specifically simplified forms such as the Easy 8 Form — is under formal investigation as a low-risk, non-pharmacological adjuvant strategy targeting the FSDSC, and may be considered for discussion with patients seeking integrative survivorship care options pending efficacy data. Patient selection for future TC programs should prioritize BCS experiencing concurrent fatigue, sleep disturbance, and depressive symptoms, as the intervention is theoretically and empirically targeted at this co-occurring cluster rather than isolated symptoms. Clinicians and health service planners in regional Australia should monitor results from this trial, as positive feasibility and acceptability findings would provide the foundation for a powered randomized controlled trial and could inform integration of TC into structured primary-care-based survivorship programs.