Quality of Life of Patients With Glioblastoma (GBM) Treated With Tumor-Treating Fields



Status:Recruiting
Conditions:Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/16/2018
Start Date:August 8, 2018
End Date:September 2022
Contact:Katherine B Peters, MD, PhD
Email:dukebrain1@dm.duke.edu
Phone:919-684-5301

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ACTION: A Longitudinal Observational Study of Quality of Life, Functional Capacity and Physical Function in Glioblastoma Patients Treated With Tumor-Treating Fields

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.

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.
We found this trial at
1
site
Durham, North Carolina 27710
Principal Investigator: Katherine B Peters, MD, PhD
Phone: 919-684-5301
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Durham, NC
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