Efficacy of mindfulness-based stress reduction versus usual care in patients with breast cancer: a meta-analysis with trial sequential analysis of randomized controlled trials.

Abstract

Mindfulness-based stress reduction (MBSR) has shown promise in improving physical and mental health in breast cancer patients, warranting further comprehensive evaluation. This meta-analysis aimed to assess the effects of MBSR compared to usual care on the physical and psychological well-being of patients with breast cancer. A systematic search of Web of Science, PubMed, Cochrane Library, and Embase was conducted to identify RCTs published up to October 5, 2025. Eligible studies enrolled patients with breast cancer at any stage, compared MBSR with usual care or waitlist control, and reported psychological, symptom-related, or quality of life (QoL) outcomes. Non-randomized studies, single-arm trials, duplicate reports, studies without relevant outcomes or sufficient data, and reviews, case reports, conference abstracts, letters, and animal studies were excluded. The primary outcomes were anxiety, depression, fatigue, and overall QoL. Standardized mean differences (SMDs) or mean differences (MDs) with 95% confidence intervals (CIs) were pooled according to outcome measurement scales. Heterogeneity was assessed using I2, Cochran's Q test, and 95% prediction intervals (PIs); fixed- or random-effects models were selected according to heterogeneity. Subgroup, sensitivity, and publication bias analyses were performed. Trial sequential analysis was conducted using TSA v0.9.5.10 Beta. The protocol was registered in PROSPERO (CRD420261277936). This meta-analysis included 20 studies comprising 2534 breast cancer patients. The overall results indicated that compared with usual care, MBSR significantly alleviated anxiety (SMD: -0.489, 95% CI: -0.734 to -0.244, 95% PI: -1.520 to 0.541), depression (SMD: -0.258, 95% CI: -0.347 to -0.170, 95% PI: -0.650 to 0.083), and fatigue (SMD: -0.399, 95% CI: -0.562 to -0.236, 95% PI: -0.963 to 0.166), while markedly improving overall QoL (SMD: 0.262, 95% CI: 0.059 to 0.465, 95% PI: -0.311 to 0.836). Additional benefits of MBSR included reductions in perceived stress and pain, improvements in posttraumatic growth, and decreases in total mood disturbance (all p < 0.05). Further subgroup analyses revealed that the 8-week MBSR protocol yielded more psychological and QoL improvements compared to the 6-week program. Notably, the benefits of MBSR in reducing depression, fatigue, perceived stress, and promoting posttraumatic growth remained observable at 4 to 9 weeks after the intervention (all p < 0.05), emphasizing its sustained efficacy. Our findings support MBSR as an effective intervention for improving the psychological health and QoL of breast cancer patients. Future research should focus on the long-term efficacy of MBSR in this population. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD420261277936.