ACTION: Multi-center Observational QoL Study NovoTTF (Novocure/Exercise) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the study device (NovoTTF) has an influence on quality of life, including exercise, sleep habits, and mood, in patients with glioblastoma or gliosarcoma.

What is the Condition Being Studied?

Glioblastoma and Gliosarcoma

Who Can Participate in the Study?

Adults who:
-Are diagnosed with glioblastoma or gliosarcoma
-Have completed radiation and temozolomide therapy-
-Can complete a walk test without a walker, cane, or other assist
-Have a smart phone and internet access
-Plan to use the NovoTTF device

For more information about who can be in this study, please contact the study team.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Wear a NovoTTF device, which will create electric fields to stop tumor cells from growing, and a FitBit (watch-type thing that measures your health and fitness)
-Have 4 clinic visits about 8 weeks apart
-Have physical exams and blood draws at the beginning and end of the study
-Complete surveys asking about your mood, sleep habits, exercise habits, and other topics in your life
-Complete a six-minute walk test at the beginning and at the end of the study
-Allow the study team to collect data from your FitBit

Study Details

Full Title
ACTION: A Multi-center Longitudinal Observational Study of Quality of Life, Functional Capacity and Physical Function in Glioblastoma Patients Treated with Tumor-Treating Fields
Principal Investigator
Protocol Number
IRB: PRO00088890
NCT: NCT03501134
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698