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| Name | Class |
|---|---|
| NovoCure Ltd. | INDUSTRY |
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This purpose of this study is to describe the effect of Tumor Treating Fields (NovoTTF) on quality of life (QOL), including exercise, sleep quality, and mood, in patients with World Health Organization (WHO) Grade IV malignant glioma who have been prescribed and approved to receive Optune™. This is an observational, longitudinal study, meaning that information about QOL will be collected over time while the patient is using the NovoTTF device (for example, Optune™).
Patients will be provided with a Fitbit Charge HR™, which they will begin wearing immediately to collect baseline information. The study team will teach the patients how to use the Fitbit and the associated smart phone application. Patients will also set an account with a platform that will provide information from the Fitbit (number of steps, sleep behaviors, and exercise log) to the study team. Patients will also have blood drawn, do a 6-minute walk test, and complete questionnaires at clinic visits 1, 8, 16, and 24 weeks after receiving the Fitbit. At the end of the study, patients will return the Fitbit to the study team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor treating fields | Patients diagnosed with WHO Grade IV malignant glioma who are approved and planned to use the NovoTTF device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovoTTF | Device | We are studying the effect of Tumor Treating Fields (NovoTTF), for example Optune™, on the quality of life, including exercise, sleep quality, and mood, of patients with malignant glioma who plan to use the NovoTTF device. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity between baseline and week 24 | Mean change between baseline and week 24 in total physical activity (MET-h/wk) as measured by the Godin Leisure Time Questionnaire | Baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life between baseline and week 24 | Mean change from baseline at week 24 in subscales of the Functional Assessment of Cancer Therapy Brain (FACT-Br) and Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) | Baseline, 24 weeks |
| Change in sleep quality between baseline and week 24 |
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Inclusion Criteria:
Written informed consent prior to beginning specific protocol procedures
Histologically proven World Health Organization (WHO) grade IV malignant glioma
Completed standard-of-care treatment for newly diagnosed WHO grade IV malignant glioma, consisting of temozolomide (TMZ) and radiation therapy (RT)
Signed Optune™ Prescription Form indicating intention of initiating NovoTTF therapy
Stable disease status
Patients ≥ 18 years of age
Karnofsky Performance Status (KPS) ≥ 70
Patient must be able to ambulate and complete the 6-minute walk test without use of a walker, cane, or any assist device
Technology requirement:
Exclusion Criteria:
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Patients diagnosed with WHO Grade IV malignant glioma who are approved for and intend to use NovoTTF therapy
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| Name | Affiliation | Role |
|---|---|---|
| Katherine B Peters, MD, PhD | The Preston Robert Tisch Brain Tumor Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Preston Robert Tisch Brain Tumor Center at Duke | Durham | North Carolina | 27710 | United States |
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| Label | URL |
|---|---|
| The Preston Robert Tisch Brain Tumor Center at Duke | View source |
| Duke Cancer Institute | View source |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Mean change from baseline at week 24 in sleep quality as measured by the Pittsburgh Sleep Quality Assessment (PSQI) |
| Baseline, 24 weeks |
| Change in patient's mood state between baseline and week 24 | Mean change from baseline at week 24 in mood as measured by the Beck Depression Inventory (BDI) | Baseline, 24 weeks |
| Change in functional capacity between baseline and week 24 | Mean change from baseline at week 24 in functional capacity as measured by the 6-minute walk test | Baseline, 24 weeks |
| Change from baseline in average daily number of steps taken at 8, 16, and 24 (±3) weeks | Mean change from baseline at week 8, 16, and 24 in the average daily number of steps as measured by the Fitbit among patients treated with Novo TTF | Baseline, 8, 16, 24 weeks |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |