The SPIZ study: rationale and protocol of a randomized controlled trial to optimize interdisciplinary care of patients following cellular therapy through a digitally supported, cross-regional and cross-sectoral care model.
Allogeneic hematopoietic cell transplantation (alloHCT) and chimeric antigen receptor T (CAR T)-cell therapy represent established therapeutic modalities for selected hematologic malignancies but are associated with substantial morbidity, high healthcare costs, and a considerable risk of severe complications, including death. This necessitates specialized and continuous post-treatment care, which is currently insufficiently standardized and still largely delivered predominantly through in-person and nonintegrated processes. We aimed to develop a comprehensive and innovative post-treatment care program for patients after alloHCT and CAR T-cell therapy based on an interdisciplinary, digitally supported, cross-regional and, cross-sectoral approach, and to evaluate its effectiveness in a randomized controlled trial (RCT). Developed by a multidisciplinary team, the intervention involves case managers and home visits by onco nurses, supported by digital components. These include patient-reported monitoring of vital signs and symptoms via a mobile application, video consultations, and virtual case conferences with community-based hematologists. The evaluation of effectiveness includes both quantitative outcomes, such as mortality and rehospitalization rates, and qualitative data derived from semi-structured interviews. The required ethics approvals were obtained in due time, and the three study centers were successfully initiated in 2024. As of January 2026, recruitment has been completed, and a total of 306 patients were successfully enrolled and randomized in a 1:1 ratio to receive either the SPIZ intervention or routine care. Funded and supported by the Federal Joint Committee (G-BA), a positive evaluation could facilitate the integration of the proposed care model into routine clinical practice, thereby strengthening post-treatment care for patients undergoing cellular therapy across Germany.
Authors
Schneider Schneider, Müller Müller, Herbst Herbst, Slesaczeck Slesaczeck, Schmädig Schmädig, Schmidt Schmidt, Illmer Illmer, Leppla Leppla, Valenta Valenta, De Geest De Geest, Teynor Teynor, Wolfien Wolfien, Ernst Ernst, Bischof Bischof, Schmitt Schmitt, Hänel Hänel, Metzeler Metzeler, Platzbecker Platzbecker, Vučinić Vučinić, Schetelig Schetelig, Bornhäuser Bornhäuser, Middeke Middeke, Egger-Heidrich Egger-Heidrich
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