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

Study Purpose

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™).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03501134
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Katherine B Peters, MD, PhD
Principal Investigator Affiliation The Preston Robert Tisch Brain Tumor Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Malignant Glioma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: Tumor treating fields

Patients diagnosed with WHO Grade IV malignant glioma who are approved and planned to use the NovoTTF device

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Durham, North Carolina

Status

Address

The Preston Robert Tisch Brain Tumor Center at Duke

Durham, North Carolina, 27710

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