Somatic acupressure for the management of the fatigue-sleep disturbance-depression symptom cluster in breast cancer survivors: a study protocol for a phase III randomised controlled trial.

INTRODUCTION

The fatigue-sleep disturbance-depression symptom cluster (FSDSC) is commonly experienced by breast cancer (BC) survivors, leading to a deteriorated quality of life (QoL). Somatic acupressure (SA) has been recommended as a promising non-pharmacological intervention for cancer-related fatigue (the core symptom of the FSDSC) in the guidelines, showing its encouraging role in relieving cancer-related sleep disorders, fatigue and depression. This phase III randomised controlled trial (RCT) is designed to evaluate the effects, safety and cost-effectiveness of SA for managing the FSDSC in BC survivors.

METHODS

This phase III RCT will be a partial-blinded, sham-controlled, three-arm, parallel clinical trial, involving a 7-week SA intervention period and a 12-week follow-up period. 108 BC survivors will be randomly allocated in a ratio of 1:1:1 to either a true SA group (self-administered acupressure plus usual care), a sham SA group (self-administered light acupressure at non-acupoints plus usual care) or a usual care group. The primary outcomes will be the effectiveness of SA on the FSDSC at both the individual symptom level and cluster symptom level. Each individual symptom will be specifically measured by the Brief Fatigue Inventory (fatigue), the Pittsburgh Sleep Quality Index (sleep disturbance) and the Hospital Anxiety and Depression Scale-Depression (depression). The cluster symptom level will be measured by using an FSDSC composite score, an averaging score of three separated 0-10 numeric rating scales for fatigue, depression and sleep disturbance. The secondary outcomes will include QoL (measured by the Functional Assessment of Cancer Therapy-Breast), adverse events and cost-effectiveness. Outcomes will be assessed at baseline (week 0), immediately after intervention (week 7) and follow-up (week 19). All outcomes will be analysed based on the intention-to-treat principle using the Statistical Package for Social Science (SPSS 25) software.

ETHICS AND DISSEMINATION

Ethical approvals of this study have been granted by the Human Research Ethics Committee at Charles Darwin University (H22110) and the Clinical Trial Ethics Committee at the Affiliated Hospital of Zunyi Medical University (KLL-2023-594), and the Second Affiliated Hospital of Zunyi Medical University (KYLL-2023-058). Findings from this trial will be published in peer-reviewed journals and presented at professional conferences.

TRIAL REGISTRATION NUMBER

NCT06412107.