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
8 affiliations
- 1Department of Medicine I, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany
- 2Department of Nursing, Medical Center, University of Freiburg, Freiburg, Germany
- 3Institute of Nursing Science, Department Public Health, University of Basel, Basel, Switzerland
- 4Nursing Science, Institute of Health Sciences, Medical Faculty, University of Tübingen, Tübingen, Germany
- 5Faculty of Computer Science, Augsburg University of Applied Sciences, Augsburg, Germany
- 6Department of Hematology, Cantonal Hospital Aarau, Aarau, Switzerland
- 7Department of Hematology, University Hospital Basel, Basel, Switzerland
- 8Academic Center for Nursing and Midwifery, Department of Public Health and Primary Care, Katholieke Universiteit (KU) Leuven, Leuven, Belgium
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.
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00277-026-07333-1.
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BibTeX
@article{leppla2026evaluating,
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}},
author = {Lynn Leppla and Sabine Valenta and Kris Denhaerynck and Anja Schmid and Janette Ribaut and Alexandra Teynor and Thomas Meyer and Claudia Wehr and Robert Zeiser and Sabine Gerull and Jörg Halter and Jakob Passweg and Sabina De Geest},
journal = {Annals of Hematology},
year = {2026},
month = oct,
doi = {10.1007/s00277-026-07333-1},
url = {https://doi.org/10.1007/s00277-026-07333-1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - 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
AU - Lynn Leppla
AU - Sabine Valenta
AU - Kris Denhaerynck
AU - Anja Schmid
AU - Janette Ribaut
AU - Alexandra Teynor
AU - Thomas Meyer
AU - Claudia Wehr
AU - Robert Zeiser
AU - Sabine Gerull
AU - Jörg Halter
AU - Jakob Passweg
AU - Sabina De Geest
PY - 2026
DA - 2026/10/24
JO - Annals of Hematology
DO - 10.1007/s00277-026-07333-1
UR - https://doi.org/10.1007/s00277-026-07333-1
AB - 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. Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00277-026-07333-1.
SN - 0939-5555
SN - 1432-0584
ER -