Primary results of the BETTER-CARE trial: Implementation of a needs-adapted and individualized follow-up care after primary breast cancer.

Abstract

LBA510 Background: Follow-up care after primary breast cancer is a central component of oncological care and is gaining importance in light of increasing survival rates. In addition, an increasing variety of adjuvant treatment concepts with differing toxicities exists and individual physical, psychological, and social consequences of the disease and its treatment are receiving greater attention. However, internationally standardized follow-up care only partially meets these heterogeneous and dynamic needs. The aim of this study was to evaluate a needs-adapted follow-up care concept within the framework of a cluster intervention study. Methods: BETTER-CARE is a parallel-arm controlled trial with 30 clusters (certified Breast Cancer Centers) across Germany randomized 1:1, that was funded by the Federal Joint Committee (G-BA, grant 01NVF20015). Breast cancer patients of all genders aged 18 years or older no later than 10 weeks after completion of curative primary treatment with informed consent were included. The needs- and risk-adapted complex intervention comprised a multidisciplinary care network, digital platforms and just-in-time adaptive interventions. The control group received usual care defined by clinical guidelines. The primary endpoint was health-related quality of life (HRQoL, EORTC QLQ-C30 global health) at 12-month. Secondary endpoints included treatment adherence, late effects and psychiatric comorbidities, among others. To detect an effect with a power of 90% and a significance level of 5%, a sample size of 570 patients per arm was planned. Linear univariable and multivariable mixed-effects models were applied adjusting for respective baseline values, age, molecular subtype, BRCA detection and Charlson-Comorbidity-Index. Results: Between 2023 and 2025, 30 clusters were randomly assigned to the intervention (n=15) or control group (n=15), no cluster dropped out. 338 of 410 patients in the intervention and 445 of 523 in the control group were included in the modified ITT analysis (data on primary endpoint available). At follow-up there was no significant difference in HRQoL (adjusted Odds Ratio (aOR): 1.61 (95%-CI: -1.4-4.62)). The intervention group showed significantly lower proportions of fatigue (18.3% vs 24.4%, aOR: 0.57 (95%-CI: 0.37-0.86)), depression (11.3% vs 19.3%, aOR 0.46 (95%-CI: 0.28-0.75)), cognitive impairment (35.5% vs 47.5%, aOR: 0.52 (95%-CI: 0.38-0.71)), neurotoxicity (40.8% vs 50.3%, aOR: 0.68 (95%-CI: 0.5-0.93)) and restrictions in daily activities (42.3% vs 50.1%, aOR: 0.65 (95%-CI: 0.48-0.88)). No differences were identified for the remaining secondary endpoints. Conclusion: No differences were identified between the intervention and control group regarding the primary endpoint HRQoL. Positive effects regarding psychiatric comorbidities, late side effects and activities in daily living were found in the intervention group. Implementing this complex intervention can be particularly useful for improving neuropsychiatric outcomes. Clinical trial information: DRKS00028840.