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

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ClinicalTrials.gov Identifier: NCT03501134
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
Duke University

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™).

Condition or disease Intervention/treatment
Malignant Glioma 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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ACTION: A Longitudinal Observational Study of Quality of Life, Functional Capacity and Physical Function in Glioblastoma Patients Treated With Tumor-Treating Fields
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in physical activity between baseline and week 24 [ Time Frame: Baseline, 24 weeks ]
    Mean change between baseline and week 24 in total physical activity (MET-h/wk) as measured by the Godin Leisure Time Questionnaire


Secondary Outcome Measures :
  1. Change in quality of life between baseline and week 24 [ Time Frame: Baseline, 24 weeks ]
    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)

  2. Change in sleep quality between baseline and week 24 [ Time Frame: Baseline, 24 weeks ]
    Mean change from baseline at week 24 in sleep quality as measured by the Pittsburgh Sleep Quality Assessment (PSQI)

  3. Change in patient's mood state between baseline and week 24 [ Time Frame: Baseline, 24 weeks ]
    Mean change from baseline at week 24 in mood as measured by the Beck Depression Inventory (BDI)

  4. Change in functional capacity between baseline and week 24 [ Time Frame: Baseline, 24 weeks ]
    Mean change from baseline at week 24 in functional capacity as measured by the 6-minute walk test

  5. Change from baseline in average daily number of steps taken at 8, 16, and 24 (±3) weeks [ Time Frame: Baseline, 8, 16, 24 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501134


Contacts
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Contact: Katherine B Peters, MD, PhD 919-684-5301 dukebrain1@dm.duke.edu
Contact: Kristen Fisher 919-684-5301 dukebrain1@dm.duke.edu

Locations
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United States, North Carolina
The Preston Robert Tisch Brain Tumor Center at Duke Recruiting
Durham, North Carolina, United States, 27710
Contact: Katherine B Peters, MD, PhD    919-684-5301    dukebrain1@dm.duke.edu   
Contact: Kristen Fisher    919-684-5301    dukebrain1@dm.duke.edu   
Principal Investigator: Katherine B Peters, MD, PhD         
Sponsors and Collaborators
Duke University
NovoCure Ltd.
Investigators
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Principal Investigator: Katherine B Peters, MD, PhD The Preston Robert Tisch Brain Tumor Center

Additional Information:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03501134     History of Changes
Other Study ID Numbers: Pro00088890
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Pro000888900
Katherine Peters
Optune
NovoTTF
ACTION
Quality of life
Tumor treating fields
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue