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

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™).

Study Overview

• Status: Completed
• Conditions: Malignant Glioma
• Intervention / Treatment: Device: NovoTTF

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • The Preston Robert Tisch Brain Tumor Center at Duke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tumor treating fields; Patients diagnosed with WHO Grade IV malignant glioma who are approved and planned to use the NovoTTF device	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity between baseline and week 24	Mean change between baseline and week 24 in total physical activity (MET-h/wk) as measured by the Godin Leisure Time Questionnaire	Baseline, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life between baseline and week 24	Mean change from baseline at week 24 in subscales of the Functional Assessment of Cancer Therapy Brain (FACT-Br) and Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F)	Baseline, 24 weeks
Change in sleep quality between baseline and week 24	Mean change from baseline at week 24 in sleep quality as measured by the Pittsburgh Sleep Quality Assessment (PSQI)	Baseline, 24 weeks
Change in patient's mood state between baseline and week 24	Mean change from baseline at week 24 in mood as measured by the Beck Depression Inventory (BDI)	Baseline, 24 weeks
Change in functional capacity between baseline and week 24	Mean change from baseline at week 24 in functional capacity as measured by the 6-minute walk test	Baseline, 24 weeks
Change from baseline in average daily number of steps taken at 8, 16, and 24 (±3) weeks	Mean change from baseline at week 8, 16, and 24 in the average daily number of steps as measured by the Fitbit among patients treated with Novo TTF	Baseline, 8, 16, 24 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: NovoCure Ltd.
• Investigators: Principal Investigator: Katherine B Peters, MD, PhD, The Preston Robert Tisch Brain Tumor Center

Publications and helpful links

Helpful Links

• Duke Cancer Institute
• The Preston Robert Tisch Brain Tumor Center at Duke

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 8, 2018
• Primary Completion (ACTUAL): June 3, 2021
• Study Completion (ACTUAL): June 3, 2021

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (ACTUAL): April 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Glioblastoma; Katherine Peters; Optune; NovoTTF; Pro000888900; ACTION; Tumor treating fields
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma
• Other Study ID Numbers: Pro00088890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No