Effects of self-acupressure on the fatigue-sleep disturbance-depression symptom cluster in breast cancer survivors: a phase III randomised controlled trial

Abstract

PURPOSE: To explore the effectiveness and safety of self-acupressure intervention on the fatigue-sleep disturbance-depression symptom cluster (FSDSC) among breast cancer (BC) survivors and to explore within-trial costs associated with the intervention. METHODS: Eligible participants were randomly allocated to a true self-acupressure group, a sham self-acupressure group or a usual care group (36 in each). The primary outcomes were the FSDSC at both the individual symptom level and cluster symptom level. Individual symptoms were measured by the Brief Fatigue Inventory, the Pittsburgh Sleep Quality Index, and the Hospital Anxiety and Depression Scale-Depression, respectively. The cluster level was calculated as the mean of three separate 0-10 numeric rating scale scores for fatigue, depression, and sleep disturbance. The secondary clinical outcome was quality of life (QoL) measured by Functional Assessment of Cancer Therapy-Breast (FACT-B). Outcomes were assessed at baseline (T0, week 0), immediately after intervention (T1, week 7) and after follow-up (T2, week 19). Safety and related costs within trial were also reported. RESULTS: Ninety-three participants completed the study. Significant group-by-time interactions were observed for all clinical outcomes and QoL. Subsequent pairwise comparisons showed that the true self-acupressure group had significantly better FSDSC than the other groups at T1 and T2 (all p < 0.01). At the individual symptom level, the true self-acupressure group also had significantly better PSQI and HADS-D scores than both comparison groups at T1 and T2 (all p < 0.05). For BFI, the true self-acupressure group had significantly lower scores than the usual care group at both T1 and T2 (both p < 0.0001), whereas the difference between the true and sham self-acupressure groups was only statistically significant at T2 (p = 0.0076). For QoL, the true self-acupressure group had significantly higher FACT-B total scores than the usual care group at T1 and T2 (both p < 0.0001). The difference in FACT-B total score between the true and sham self-acupressure groups was not statistically significant at T1 (p = 0.069) but was statistically significant at T2 (p = 0.0002). No adverse events were reported. During the trial, only one participant in each of the true self-acupressure and usual care groups reported healthcare resource use (medications plus clinical visits for symptom relief), with a sum cost of ¥931.06 and ¥2247.44, respectively. The one-off cost of video production for the true self-acupressure group was ¥2879. CONCLUSIONS: The self-acupressure is a safe intervention that demonstrated positive effects in managing the FSDSC in BC survivors. While self-acupressure is recommended to support symptom management in cancer survivorship, its cost-effectiveness remains uncertain and warrants further investigation. TRIAL REGISTRATION: ClinicalTrials.gov (NCT06412107), Date: 02/26/2024. The study protocol has been published.