Brain TumorNCT02674945
Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase
An observational study of Brain Tumor, run by University of Minnesota at 1 site in United States.
Trial summary
This project attempts to correlate wireless activity data with quality of life and sleep surveys in order to find a new method of monitoring patients during their treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Wireless Activity tracker: Fitbit
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2018
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consentable patients suffering from a single or multiple primary or metastatic brain tumors
Who may be able to join
- diagnosed with primary or metastatic brain tumor
- able to wear wireless activity tracker
- able to complete QOL and sleep surveys every 3 months
Who cannot join
- unable to provide consent
- age < 18
- lack of use of the wireless activity tracker for more than 2 consecutive months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
This project attempts to correlate wireless activity data with quality of life and sleep surveys in order to find a new method of monitoring patients during their treatment.
Read the detailed description
This project proposes the investigation, validation, and use of a wireless activity tracker to better understand and improve the quality of life of patients suffering from brain tumors. The Fitbit flex wireless syncing activity tracker will be distributed to 75 patients, and the electronic infrastructure to automatically track patients will be created and adapted for the cohort. Surveys will routinely assess the ease-of-use and any problems arising. This heterogenous population of patients suffering from brain tumors will be tracked and compared through routine evaluation of their quality of life through well-established surveys, including the SF-36 and FACT-Br. The association between data recorded from the activity tracker and the QOL surveys will be quantified to validate the activity tracking data as a surrogate measure of part, if not all, of QOL as well as sleep.
- Conditions
- Brain Tumor
- Being tested
- Wireless Activity tracker: Fitbit
- Keywords
- fitbit, activity tracker, sleep, quality of life
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless Activity tracker: FitbitDevice
Patients will wear a Fitbit flex
| Study group | Role | What they receive |
|---|---|---|
| Wireless Activity tracker: Fitbit | Patients with brain tumor(s) will be give a wireless activity tracker (fitbit flex) to use during treatment. They will complete quality of life surveys and a sleep survey. Receives: Device: Wireless Activity tracker: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity measured in steps
Measured: 1 year delineated by minute
Secondary outcomes (3)
Sleep
wireless activity will attempt to monitor sleep cycles when the device is worn
Measured: per night over 1 year
Quality of Life - SF-36
SF-36
Measured: months 0, 3, 6, 9, and 12
Quality of Life - Fact- Br
Fact-Br
Measured: months 0, 3, 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2018
- Study completionSep 2018
Why it stopped: Low enrollment, unable to power adequately
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Darrow, MD MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674945
- Sponsor's protocol ID
- 1406M51644
- Other IDs
- #2014NTLS054
- Status last verified
- Jun 2022
- First submitted
- 4 Jan 2016
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual data will not be shared. De-identified group data will be made available
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase
- ClinicalTrials.gov ID
- NCT02674945
- Acronym / sponsor ID
- 1406M51644
- Conditions
- Brain Tumor
- Keywords
- fitbit, activity tracker, sleep, quality of life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment, unable to power adequately
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project attempts to correlate wireless activity data with quality of life and sleep surveys in order to find a new method of monitoring patients during their treatment.
Detailed description
This project proposes the investigation, validation, and use of a wireless activity tracker to better understand and improve the quality of life of patients suffering from brain tumors. The Fitbit flex wireless syncing activity tracker will be distributed to 75 patients, and the electronic infrastructure to automatically track patients will be created and adapted for the cohort. Surveys will routinely assess the ease-of-use and any problems arising. This heterogenous population of patients suffering from brain tumors will be tracked and compared through routine evaluation of their quality of life through well-established surveys, including the SF-36 and FACT-Br. The association between data recorded from the activity tracker and the QOL surveys will be quantified to validate the activity tracking data as a surrogate measure of part, if not all, of QOL as well as sleep.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wireless Activity tracker: Fitbit | – | Device: Wireless Activity tracker: FitbitPatients with brain tumor(s) will be give a wireless activity tracker (fitbit flex) to use during treatment. They will complete quality of life surveys and a sleep survey. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consentable patients suffering from a single or multiple primary or metastatic brain tumors
Key inclusion criteria (3 listed)
- diagnosed with primary or metastatic brain tumor
- able to wear wireless activity tracker
- able to complete QOL and sleep surveys every 3 months
Key exclusion criteria (3 listed)
- unable to provide consent
- age < 18
- lack of use of the wireless activity tracker for more than 2 consecutive months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wireless Activity tracker: FitbitPatients will wear a Fitbit flex | Device | Wireless Activity tracker: Fitbit |
Primary outcome
Activity measured in steps
Time frame: 1 year delineated by minute
3 secondary outcomes
Sleep
Time frame: per night over 1 year
Quality of Life - SF-36
Time frame: months 0, 3, 6, 9, and 12
Quality of Life - Fact- Br
Time frame: months 0, 3, 6, 9, and 12
Results and safety
The study was stopped early (reason given: Low enrollment, unable to power adequately). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No. Individual data will not be shared. De-identified group data will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Darrow, MD MPH principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, run by University of Minnesota 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 3 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: stopped early, as of the sponsor's last update on 28 Jun 2022. 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 was stopped early (reason given: Low enrollment, unable to power adequately). Results are not available in the source record.
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?
Activity measured in steps (time frame: 1 year delineated by minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2022.