Quality of Life of Patients With Glioblastoma (GBM) Treated With Tumor-Treating Fields
Completed
Conditions studied: Malignant Glioma
In brief
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™).
Key facts
- Study ID
- NCT03501134
- Run by
- Duke University
- People needed
- 20
- Starts
- 2018-08-08
- Expected to finish
- 2021-06-03
- Last updated by the study team
- 2021-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Patients need to own a smart phone that can interface with the Fitbit Charge HR™.
- Patients must be willing to provide their own internet access for this study. This will include either a data plan or Wi-Fi access on the patient's smart phone for use of the Fitbit Charge HR™ App. They will also need internet access (through their smart phone or home computer) for setting up a SGHIx account. Patients are welcome to use the free guest Wi-Fi access within the Duke Outpatient clinic area for the purpose of this study.
- Patients will need a home computer or adaptor with USB port to charge the Fitbit Charge HR™.
You may not qualify if…
- Non-English speaking or inability to read and understand English.
- Presence of cardiovascular disease that would make physical activity risky, at the discretion of the provider.
- Any patient who is unable to comprehend and operate the activity tracker, at the discretion of the enrolling provider.
Where it is running
- The Preston Robert Tisch Brain Tumor Center at Duke — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.