TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study
NCT04717739 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2023-01-10
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.
Conditions
Interventions
- DEVICE
-
TTFields
Tumor Treating Fields (TTFields) help slow down or stop glioblastoma cancer cells from dividing by disrupting dividing mechanism of cancer cells leading to apoptosis. TTFields are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located. These transducer arrays are applied to the scalp and are connected to the wearable and portable device. TTFields are approved for the treatment of newly diagnosed and recurrent GBM.
Sponsors & Collaborators
-
NovoCure Ltd.
lead INDUSTRY
Principal Investigators
-
Martin Glas, Prof. · University hospital Essen, Essen, Germany
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-30
- Primary Completion
- 2024-12-01
- Completion
- 2025-02-01
- FDA Device
- Yes
Countries
- Germany
Study Locations
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