Evaluating the effectiveness of the eHealth-faciLitated SMILe-integrated care model on treatment burden, quality of life and graft-versus-host disease after allogeneic stem cell transplantation: results of two European randomized controlled implementation studies

The SMILe Integrated Care Model (SMILe-ICM) has previously demonstrated feasibility, successful implementation, and promising effects on survival, re-hospitalization, and cost-effectiveness following allogeneic stem cell transplantation (alloSCT). To complement these findings and provide a more comprehensive evaluation of the intervention's effects, we evaluated patient-reported and clinical secondary outcomes from two RCTs. Data from two hybrid effectiveness-implementation RCTs conducted at two European alloSCT centers (Germany, Switzerland) were analyzed. Adult alloSCT recipients were randomized 1:1 to usual care (UCG) or the SMILe-ICM, a multicomponent intervention combining eHealth with advanced practice nurse-led self-management support. Treatment burden was assessed using the Patients' Experience of Treatment and Self-Management (PETS 2.0), HRQoL using the EQ-5D-5 L, and GvHD outcomes using EBMT-registry data. Analyses followed an intention-to-treat approach. The current study examined data from 152 patients (76 SMILe-ICM, 76 UCG). Treatment burden was lower in the SMILe-ICM group, with significant differences in five dimensions. Both groups' HRQoL improved over time without significant between-group differences. The cumulative incidence of acute GvHD was lower in the SMILe-ICM group than in the UCG (34.2% vs. 55.3%; HR 0.54, 95% CI 0.33-0.88; p = 0.01); chronic GvHD did not differ significantly (p = 0.64). SMILe-ICM reduced treatment burden and was associated with a lower cumulative incidence of grades II-IV acute GvHD, while HRQoL and chronic GvHD did not differ significantly between groups. The acute GvHD finding warrants further investigation to determine whether and through which pathways integrated APN-led survivorship care may influence post-alloSCT clinical outcomes.