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

NCT ID: NCT03501134

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2021-06-03

Brief Summary

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™).

Detailed Description

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.

Conditions

Malignant Glioma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tumor treating fields

Patients diagnosed with WHO Grade IV malignant glioma who are approved and planned to use the NovoTTF device

NovoTTF

Intervention Type: 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.

Interventions

NovoTTF

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NovoCure Ltd.

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine B Peters, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Preston Robert Tisch Brain Tumor Center

Locations

The Preston Robert Tisch Brain Tumor Center at Duke

Durham, North Carolina, United States

Countries

United States

Related Links

http://tischbraintumorcenter.duke.edu

The Preston Robert Tisch Brain Tumor Center at Duke

http://www.dukecancerinstitute.org/

Duke Cancer Institute

Other Identifiers

Pro00088890

Identifier Type: -

Identifier Source: org_study_id