Clinical trial NCT03501134: Quality of Life of Patients With Glioblastoma (GBM) Treated With Tumor-Treating Fields
Official title: ACTION: A Longitudinal Observational Study of Quality of Life, Functional Capacity and Physical Function in Glioblastoma Patients Treated With Tumor-Treating Fields
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Glioma
Keywords: Pro000888900
Katherine Peters
Optune
NovoTTF
ACTION
Quality of life
Tumor treating fields
Glioblastoma
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: NovoCure Ltd.
First posted: 2018-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with WHO Grade IV malignant glioma who are approved for and intend to use NovoTTF therapy

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.

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.

Primary outcomes:
measure: Change in physical activity between baseline and week 24
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Change in quality of life between baseline and week 24
timeFrame: Baseline, 24 weeks
measure: Change in sleep quality between baseline and week 24
timeFrame: Baseline, 24 weeks
measure: Change in patient's mood state between baseline and week 24
timeFrame: Baseline, 24 weeks
measure: Change in functional capacity between baseline and week 24
timeFrame: Baseline, 24 weeks
measure: Change from baseline in average daily number of steps taken at 8, 16, and 24 (±3) weeks
timeFrame: Baseline, 8, 16, 24 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: The Preston Robert Tisch Brain Tumor Center at Duke
state: North Carolina
Study officials:
affiliation: The Preston Robert Tisch Brain Tumor Center
name: Katherine B Peters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: