Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-01-05 @ 2:21 AM
Study NCT ID:
NCT03501134
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2018-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life of Patients With Glioblastoma (GBM) Treated With Tumor-Treating Fields
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
ACTION: A Longitudinal Observational Study of Quality of Life, Functional Capacity and Physical Function in Glioblastoma Patients Treated With Tumor-Treating Fields
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTION
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: