Somatic acupressure for the fatigue-sleep disturbance-depression symptom cluster in breast cancer survivors: A phase II randomized controlled trial.

OBJECTIVE: To evaluate the feasibility of the somatic acupressure (SA) for managing the fatigue-sleep disturbance-depression symptom cluster (FSDSC) among breast cancer (BC) survivors and its preliminary effects. METHODS: In this Phase II randomized controlled trial (RCT), 51 participants were randomised evenly into the true SA group, sham SA group, and usual care group. All the participants received usual care. The two SA groups performed additional true or sham self-acupressure daily for seven weeks. The primary outcomes related to the assessment of participants' recruitment and compliance with study questionnaires and interventions. Clinical outcomes assessed the preliminary effects of SA on fatigue, sleep disturbance, depression, and quality of life. Semi-structured interviews were undertaken to capture participants' experiences of participating in this study. The statistical effects of the intervention on the outcomes were modelled in repeated measures ANOVA and adjusted generalized estimating equations. RESULTS: Forty-five participants completed the SA intervention. No adverse events were reported. Over 85% of the participants could sustain for 25 days or more and 15 min or more per session, but the adherence to the intervention requirement was yet to improve. The group by time effect of the FSDSC and depression were significant (p < 0.05). Qualitative findings showed that participants positively viewed SA as a beneficial strategy for symptom management. CONCLUSIONS: The SA intervention protocol and the trial procedures were feasible. The results demonstrated signs of improvements in targeted outcomes, and a full-scale RCT is warranted to validate the effects of SA on the FSDSC.