TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of TTFields in Germany in Routine Clinical Care Study PROgram - Daily Activity, Sleep and Neurocognitive Functioning in Newly Diagnosed Glioblastoma Patients Study

Conditions
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Glioblastoma

Intervention / Treatment
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* Device: TTFields


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: min.18 years of age Newly diagnosed, histologically confirmed GBM Patient after completion of radiochemotherapy but within first 3 cycles of first-line tumor-specific maintenance chemotherapy Clinical indication of treatment with NovoTTF-200A System (Optune®) according to IFU and medical guidelines Signed informed consent Exclusion Criteria: Any foreseeable deviation from the IFU of NovoTTF-200T Device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GBM with indication for TTFields<br>newly diagnosed GBM with clinical indication for TTFields | Device: TTFields<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of usage of TTFields treatment in follow-up derived from monitoring data of the devices, standardised to usage days, as measure of compliance with TTFields treatment. | Time of usage (compliance) of TTFields treatment over time is measured using the treatment compliance report at the Follow-up period | through study completion, an average of 18 months (mean follow-up time) | 
| Number of TTFields treatment-related SAEs as assessed by the CEC standardized to one year of FU time | Number of TTFields treatment-related SAEs standardized to one year of follow-up (FU) is measured using the collection of SAEs during the follow-up period | through study completion, an average of 18 months (mean follow-up time) | 
| Changes in daily physical activity as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy | Changes in daily physical activity will be assessed by smartphone app-based clinical monitoring. | Up to 4 months after start of TTFields treatment compared to baseline | 
| Changes in sleep quality as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy | Changes in sleep quality will be assessed by smartphone app-based clinical monitoring. | Up to 4 months after start of TTFields treatment compared to baseline | 
| Changes in neurocognitive functioning as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy. | Changes in neurocognitive functioning will be assessed by means of MoCA interview tests. | Up to 4 months after start of TTFields treatment compared to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioblastoma, GBM, Tumor Treating Fields, TTFields, ePRO