Yoga intervention on the fatigue-pain-sleep disturbance symptom cluster for breast cancer patients receiving adjuvant chemotherapy: a pilot randomized controlled trial
摘要
The fatigue-pain-sleep disturbance symptom cluster is a common and notable issue negatively impacting breast cancer patients receiving adjuvant chemotherapy. Yoga is a promising strategy for symptom cluster management. This study aimed to examine the feasibility, acceptability, and preliminary effects of yoga intervention on the fatigue-pain-sleep disturbance symptom cluster in breast cancer patients receiving adjuvant chemotherapy to explore its effect on alleviating patients’ symptom burden.
MethodsIn a parallel-group pilot randomized controlled trial, 30 participants were randomly assigned to the intervention group or the control group. The participants in the control group received usual care, while those in the intervention group received yoga intervention and usual care. Feasibility was assessed using eligibility rate, recruitment rate, retention rate, adherence rate, and session attendance rate. Acceptability was assessed using a satisfaction scale and open-ended questions. The feasibility and acceptability of the intervention were evaluated post-intervention. Preliminary effects were assessed at baseline, post-intervention, and one-month follow-up.
ResultsThirty participants were recruited, with a recruitment rate of 55.6%. Two participants dropped out of the study, and ten participants in the intervention group completed all intervention sessions, with a retention rate of 93.3% and a session attendance rate of 91.4%, showing high feasibility. 92.9% of participants expressed total satisfaction with the intervention, showing high acceptability. The yoga intervention achieved statistically significant post-intervention effects on the symptom cluster severity (P = 0.042), depression (P = 0.045), and health-related quality of life (P = 0.006) in breast cancer patients receiving adjuvant chemotherapy. No adverse event was reported.
ConclusionsThis pilot study supports the feasibility and acceptability of yoga intervention for breast cancer patients receiving adjuvant chemotherapy. The results suggest that yoga intervention has potentially positive effects on the management of the fatigue-pain-sleep disturbance symptom cluster and related outcomes. Future research with a larger sample size is warranted to examine the long-term effects of yoga intervention.
Trial registrationThe study was registered on the Chinese Clinical Trial Registry (www.chictr.org.cn), and trial registration number ChiCTR2400081863. The registration date was 14/03/2024.