Implementing an evidence-based somatic acupressure intervention in breast cancer survivors with the symptom cluster of fatigue, sleep disturbance and depression: Study protocol of a Phase II randomized controlled trial

Introduction: Fatigue-sleep disturbance-depression (FSD) symptom cluster as one of the most common symptom clusters in breast cancer (BC) survivors can significantly deteriorate patients’ quality of life. Since the FSD symptom cluster management has been unsatisfactory by using pharmacological treatments alone, non-pharmacological approaches have therefore been recommended. Somatic acupressure (SA) has been a promising approach given its potential benefits for cancer-related symptom alleviation and convenience for self-practice. However, research evidence on using acupressure to manage the FSD symptom cluster has been limited. This trial is to examine the feasibility and preliminary effects of an evidence-based SA intervention for FSD symptom cluster management in BC survivors.

Methods and Analysis: This study is a Phase II randomized controlled trial (RCT) with three study arms and 1:1:1 allocation. Fifty-one early-stage BC survivors with the FSD symptom cluster will be randomly assigned to a true SA group, a sham SA group or a usual care group. All participants will receive an education booklet regarding FSD symptom cluster management advice as the usual care package. Participants in true SA group will additionally receive a 7-week self administered SA intervention. Participants in the sham SA group will additionally receive light acupressure at non-acupoints with the same frequency, session and duration of the true SA. Primary outcomes are feasibility outcomes related to subject recruitment and completion of study questionnaires and interventions. Secondary outcomes are the effects of SA on fatigue, sleep disturbance, depression, and quality of life. Descriptive statistics will be used to present all the outcomes. The secondary outcomes will be analyzed using an intent-to-treat approach.