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Malignant GliomaACTIONNCT03501134

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

An observational study of Malignant Glioma, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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™. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Glioma
What is being tested?
NovoTTF
How many people
20 participants
Where
1 siteUnited States
Study dates
8 Aug 2018to 3 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients diagnosed with WHO Grade IV malignant glioma who are approved for and intend to use NovoTTF therapy

Who may be able to join

  • 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
Show all 12Show fewer
  • 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™.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • The Preston Robert Tisch Brain Tumor Center at Duke

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: ACTION: A Longitudinal Observational Study of Quality of Life, Functional Capacity and Physical Function in Glioblastoma Patients Treated With Tumor-Treating Fields

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™).

Read the 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.

Being tested
NovoTTF
Keywords
Pro000888900, Katherine Peters, Optune, NovoTTF, ACTION, Quality of life, Tumor treating fields, Glioblastoma
Medical subject headings
Glioma, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NovoTTFDevice

    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.

Study groups in NCT03501134
Study groupRoleWhat they receive
Tumor treating fieldsPatients diagnosed with WHO Grade IV malignant glioma who are approved and planned to use the NovoTTF device
Receives: Device: NovoTTF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in physical activity between baseline and week 24

    Mean change between baseline and week 24 in total physical activity (MET-h/wk) as measured by the Godin Leisure Time Questionnaire

    Measured: Baseline, 24 weeks

Secondary outcomes (5)

  1. Change in quality of life between baseline and week 24

    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)

    Measured: Baseline, 24 weeks

  2. Change in sleep quality between baseline and week 24

    Mean change from baseline at week 24 in sleep quality as measured by the Pittsburgh Sleep Quality Assessment (PSQI)

    Measured: Baseline, 24 weeks

  3. Change in patient's mood state between baseline and week 24

    Mean change from baseline at week 24 in mood as measured by the Beck Depression Inventory (BDI)

    Measured: Baseline, 24 weeks

  4. Change in functional capacity between baseline and week 24

    Mean change from baseline at week 24 in functional capacity as measured by the 6-minute walk test

    Measured: Baseline, 24 weeks

  5. Change from baseline in average daily number of steps taken at 8, 16, and 24 (±3) 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

    Measured: Baseline, 8, 16, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2018
  2. Study start8 Aug 2018
  3. Primary completion3 Jun 2021
  4. Study completion3 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03501134
Sponsor's protocol ID
Pro00088890
Acronym
ACTION
Status last verified
Jun 2021
First submitted
10 Apr 2018
Last updated
9 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Glioma, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in physical activity between baseline and week 24 (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03501134.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

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