Article
TIGER PRO-Active study – investigating daily activity, sleep and neurocognitive functioning in glioblastoma patients applying TTFields therapy in Germany in routine clinical care
TIGER PRO-Active Studie: Untersuchung der täglichen Aktivität, des Schlafs und der neurokognitiven Funktionen bei Glioblastom-Patientinnen und -Patienten, die die TTFields-Therapie in Deutschland in der klinischen Routineversorgung anwenden
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Published: | May 25, 2022 |
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Objective: Based on the EF-14 trial, TTFields therapy is recommended in treatment guidelines for newly diagnosed glioblastoma (GBM), including the DGN and DGHO guidelines, and a service of the statutory health insurance funds. However, real-world data is limited. The currently active TIGER study (NCT03258021) will give insight into patients' therapy decision, TTFields therapy duration and compliance, quality of life, survival and adverse events in the real-world setting. Following up, we established the TIGER PROgram, a collaborative network of centers involved in the TIGER study but open also for new centers in Germany engaged to collect more real-world evidence on this therapy. The first study initiated within this program is the TIGER PRO-Active Study (NCT04717739) investigating daily activity, sleep and neurocognitive functioning in glioblastoma patients applying TTFields therapy in Germany in Routine Clinical Care that we present here.
Methods: The TIGER PRO-Active Study is a prospective, non-interventional, multi-center study in Germany. We will recruit approximately 500 adult patients with newly diagnosed glioblastoma in accordance with treatment indication for TTFields therapy over the course of 2 years. Data on changes in daily physical activity and sleep in comparison to baseline will be collected via specific smartphone apps. Additionally, changes in neurocognitive functioning will be assessed using the MoCA (Montreal Cognitive Assessment) interview test. Quality of life will be evaluated with the EORTC QLQ-C30 and –BN20 questionnaires. Further, employment status, therapy usage, and serious adverse events will be assessed. Data will be collected over a time period of at least 12 months.
Results: First results are expected in 2024.
Conclusion: The TIGER PROgram will allow us to use previously established administrative structures for new real-world studies. Also, it will enable a basic data set across different trials and thereby facilitate meta-analyses across different populations. The TIGER PRO-Active study will give more detailed insight into daily physical activity, sleep, and neurocognitive functioning of newly diagnosed GBM patients using TTFields in routine clinical care.
Figure 1 [Fig. 1]