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Brief Title: TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study
Official Title: Use of TTFields in Germany in Routine Clinical Care Study PROgram - Daily Activity, Sleep and Neurocognitive Functioning in Newly Diagnosed Glioblastoma Patients Study
Study ID: NCT04717739
Brief Summary: This non-interventional study aims to investigate change over time in cognitive function, sleep quality, and activity in daily life as important determinants of QoL in a large cohort of GBM patients in Germany treated with TTFields in routine clinical care using low-threshold, electronic PRO and modern automated tracking data analyses. The gained results will allow even better understanding of TTFields therapy in daily life of GBM patients and consequently, better informing patients about what to expect when starting this therapy, increasing therapy compliance in the long-term.
Detailed Description: Glioblastoma (GBM) is the most common malignant primary tumor of the brain with an annual incidence of approximately 3/100.000. Since 2005 the treatment for newly diagnosed GBM consisted of maximal surgical resection, approx. 60 Gy of radiotherapy together with chemotherapy using temozolomide (TMZ), followed by 6 cycles of maintenance chemotherapy. This treatment regimen demonstrated increased median overall survival (OS) from 12.1 to 14.6 months in comparison to surgery and radiotherapy alone in 2005. Since 2005, despite plenty of clinical phase III trials conducted, Tumor Treating Fields (TTFields) therapy was the first treatment shown to significantly increase median progression-free survival (PFS), OS and one to five year survival rates compared to the previous standard of care. These results led to FDA approval of TTFields for newly diagnosed GBM and were acknowledged since then by several guidelines recommending TTFields for GBM therapy (e.g. NCCN guidelines for CNS cancers V.1.2018, RCC guideline tumörer I hjärna och ryggmärg 2020-01-14 V3.0, DGHO guideline for glioma in adults ICD-10 C71 March 2019). Today, several national committees in Europe already list TTFields as reimbursed treatment (e.g. Austria, Sweden, Germany). Data with TTFields therapy in real-world setting is limited and therefore further evaluation of different treatment aspects of TTFields therapy in clinical routine are of interest. In particular the QoL-related aspects neurocognitive functioning, daily activity and sleep quality in this patient cohort is of major interest, given the limited life expectancy with this disease. This non-interventional study aims to investigate change over time in neurocognitive functioning, sleep quality, and activity in daily life as important determinants of QoL in a large cohort of GBM patients in Germany treated with TTFields in routine clinical care using low-threshold, electronic PRO and modern automated tracking data analyses. The gained results will allow even better understanding of TTFields therapy in daily life of GBM patients and consequently, better informing patients about what to expect when starting this therapy, increasing therapy compliance even further in the long-term.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Universitätsklinikum Aachen, Aachen, , Germany
Klinikum Aschaffenburg-Alzenau, Aschaffenburg, , Germany
Universitätsklinikum Augsburg (AöR), Augsburg, , Germany
Universitätsklinikum Bonn, Bonn, , Germany
Klinikum Chemnitz, Chemnitz, , Germany
Carl-Thiem-Klinikum Cottbus, Cottbus, , Germany
Universitätsklinik Carl Gustav Carus Dresden, Dresden, , Germany
Sana Kliniken Duisburg, Duisburg, , Germany
Universitätsklinikum Düsseldorf HHU, Düsseldorf, , Germany
HELIOS Klinikum Erfurt, Erfurt, , Germany
Universitätsklinikum Erlangen, Erlangen, , Germany
Universitätsklinikum Essen, Essen, , Germany
Universitätsklinikum Frankfurt Goethe-Universität, Frankfurt, , Germany
Universitätsmedizin Greifswald, Greifswald, , Germany
BG Klinikum Bergmannstrost Halle, Halle, , Germany
Onkologische Schwerpunktpraxis Dres. I. Zander und E. von der Heyde, Hannover, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum des Saarlandes, Homburg, , Germany
Universitätsklinikum Jena, Jena, , Germany
Klinikum Kassel, Kassel, , Germany
Universitätsklinikum SH Campus Kiel, Kiel, , Germany
Uniklinik Köln, Köln, , Germany
Kliniken der Stadt Köln GmbH, Köln, , Germany
Otto-von-Guericke-Universität Magdeburg, Magdeburg, , Germany
Med. Fakultät Mannheim der Universität Heidelberg, Mannheim, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
Kliniken Maria Hilf GmbH, Mönchengladbach, , Germany
Klinikum Nürnberg, Nürnberg, , Germany
Pius-Hospital Oldenburg, Oldenburg, , Germany
Niels-Stensen-Kliniken - Marienhospital Osnabrück, Osnabrück, , Germany
Universitätsmedizin Rostock, Rostock, , Germany
HELIOS Kliniken Schwerin GmbH, Schwerin, , Germany
Johanniter-Krankenhaus Genthin-Stendal GmbH, Stendal, , Germany
Klinikum Stuttgart, Stuttgart, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Paracelsus-Klinik Zwickau, Zwickau, , Germany
Name: Martin Glas, Prof.
Affiliation: University hospital Essen, Essen, Germany
Role: PRINCIPAL_INVESTIGATOR