| Home > Publications database > 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. |
| Journal Article | DKFZ-2026-02356 |
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2026
Springer
New York
Abstract: 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.
Keyword(s): Humans (MeSH) ; Hematopoietic Stem Cell Transplantation (MeSH) ; Randomized Controlled Trials as Topic (MeSH) ; Hematologic Neoplasms: therapy (MeSH) ; Patient Care Team: organization & administration (MeSH) ; Female (MeSH) ; Multicenter Studies as Topic (MeSH) ; Immunotherapy, Adoptive (MeSH) ; Male (MeSH) ; Aftercare: methods (MeSH) ; Telemedicine (MeSH) ; Allogeneic hematopoietic cell transplantation ; CAR T-cell therapy ; digital health ; post-treatment care
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