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

Abstract

Abstract 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.

The authors' abstract, as published at the source. Annals of Hematology, 2026 · DOI ↗