The SMILe Integrated Care Model, or SMILe-ICM, is a multicomponent intervention that combines eHealth tools with advanced practice nurse-led self-management support. Earlier work had already demonstrated the model’s feasibility, successful implementation, and promising effects on survival, re-hospitalization, and cost-effectiveness following allogeneic stem cell transplantation. The new analysis was designed to complement those findings by evaluating patient-reported and clinical secondary outcomes from two randomized controlled trials.

The two trials used a hybrid effectiveness-implementation design and were conducted at two European allogeneic stem cell transplantation centers, one in Germany and one in Switzerland. Adult transplant recipients were randomized 1:1 to either usual care or the SMILe-ICM. The current analysis included 152 patients, with 76 assigned to each group. Treatment burden was assessed with the Patients’ Experience of Treatment and Self-Management questionnaire, version 2.0; health-related quality of life was measured with the EQ-5D-5 L instrument; and graft-versus-host disease outcomes were drawn from European Society for Blood and Marrow Transplantation registry data. All analyses followed an intention-to-treat approach.

On the patient-reported side, treatment burden was lower in the SMILe-ICM group than in the usual care group, with statistically significant differences in five dimensions of the PETS 2.0 questionnaire. Health-related quality of life, by contrast, improved over time in both groups, and the between-group differences on the EQ-5D-5 L did not reach statistical significance.

The most notable clinical result concerned acute graft-versus-host disease. The cumulative incidence of grades II–IV acute GvHD was 34.2 percent in the SMILe-ICM group compared with 55.3 percent in the usual care group, corresponding to a hazard ratio of 0.54 with a 95 percent confidence interval of 0.33 to 0.88 and a p-value of 0.01. Chronic graft-versus-host disease, however, did not differ significantly between the groups, with a p-value of 0.64.

The researchers are measured in their interpretation. The acute GvHD finding emerged from a secondary outcomes analysis, and the authors state that it warrants further investigation to determine whether, and through which pathways, integrated advanced practice nurse-led survivorship care may influence clinical outcomes after allogeneic stem cell transplantation. Until such work clarifies the underlying mechanisms, the association between the care model and reduced acute GvHD incidence should be viewed as a signal for further study rather than an established causal effect.

Subject of Research: Effects of the eHealth-facilitated SMILe integrated care model on treatment burden, quality of life, and graft-versus-host disease after allogeneic stem cell transplantation

Article Title: 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

Article References: Leppla, L., Valenta, S., Denhaerynck, K., Schmid, A., Ribaut, J., Teynor, A., Meyer, T., Wehr, C., Zeiser, R., Gerull, S., Halter, J., Passweg, J., & De Geest, S. (2026). 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. Annals of Hematology. https://doi.org/10.1007/s00277-026-07333-1

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DOI: 10.1007/s00277-026-07333-1

Keywords: allogeneic stem cell transplantation, eHealth, integrated care model, treatment burden, graft-versus-host disease, quality of life, advanced practice nursing, self-management support, randomized controlled trial, SMILe, Evaluating, effectiveness