Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT03501134
Eligibility Criteria:
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:
* 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™.
Exclusion Criteria:
* 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.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03501134
Study Brief:
Protocol Section:
NCT03501134