A multi-modal intervention for managing the fatigue-sleep disturbance-depressed mood symptom cluster in breast cancer patients undergoing chemotherapy: A pilot study.

Objective: To examine the feasibility and acceptability of a multi-modal intervention for managing the cancer-related fatigue-sleep disturbance-depressed mood (F-S-D) symptom cluster in patients with breast cancer (BC) and receiving chemotherapy in Hong Kong, and the preliminary effects of such intervention on the occurrence of the F-S-D symptom cluster in these patients.

Methods: This study was a single-blind randomized controlled trial. Patients with BC scheduled for chemotherapy were recruited. Intervention participants received a weekly nurse-led multi-modal intervention lasting 7 weeks. The feasibility parameters and adverse events were assessed using logbook records. Acceptability was evaluated using a program evaluation questionnaire. F-S-D symptoms and quality of life (QOL) were measured at baseline (T0), upon intervention completion (T1), and 3 months after intervention completion (T2). Generalized estimating equation analyses were used.

Results: Fifty participants were enrolled. The eligibility and enrollment rates were 11% and 87.7%, respectively. The rate of adherence to the intervention was 96%. No adverse events were reported. All participants were satisfied with the intervention, which had significant effects in terms of reducing the occurrence of the F-S-D symptom cluster at T2 ( ​= ​0.035) and improving QOL at T1 and T2 (T1:  ​= ​0.035; T2:  ​= ​0.012).

Conclusions: The multi-modal intervention is a feasible, acceptable, and safe intervention that demonstrated preliminary positive effects in managing the F-S-D symptom cluster and improving QOL in patients with BC and receiving chemotherapy in Hong Kong. This study provides key insights into F-S-D symptom cluster management in patients with BC.

Trial Registration: ChiCTR2100047819 (Chinese Clinical Trial Register).