Clinical trial · Observational
Quality of Life of Patients With Glioblastoma (GBM) Treated With Tumor-Treating Fields
ACTION: A Longitudinal Observational Study of Quality of Life, Functional Capacity and Physical Function in Glioblastoma Patients Treated With Tumor-Treating Fields
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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™).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NovoTTF | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Tumor treating fields
- description
- Patients diagnosed with WHO Grade IV malignant glioma who are approved and planned to use the NovoTTF device
- interventionNames
- Device: NovoTTF
Primary outcomes (1)
- measure
- Change in physical activity between baseline and week 24
- timeFrame
- Baseline, 24 weeks
- description
- Mean change between baseline and week 24 in total physical activity (MET-h/wk) as measured by the Godin Leisure Time Questionnaire
Secondary outcomes (5)
- measure
- Change in quality of life between baseline and week 24
- timeFrame
- Baseline, 24 weeks
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available