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TerminatedNCT02674945Updated Jun 28, 2022

Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase

An observational study in Brain Tumor, sponsored by University of Minnesota. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-06-28.

Sponsored by University of Minnesota · Observational

Why this study was terminated
Low enrollment, unable to power adequately
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
29
Ages
18 Years to 99 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Brain Tumor

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Keywords

  • fitbit
  • activity tracker
  • sleep
  • quality of life
03

In context

Brain Neoplasms

1,993 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 29 is below the median of 100 across 389 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,210 studies on the registry; 194 are open to participants now.

Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Consentable patients suffering from a single or multiple primary or metastatic brain tumors

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosed with primary or metastatic brain tumor
  • able to wear wireless activity tracker
  • able to complete QOL and sleep surveys every 3 months

Exclusion criteria

Exclusion Criteria:

  • unable to provide consent
  • age \< 18
  • lack of use of the wireless activity tracker for more than 2 consecutive months
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
29 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Device: Wireless Activity tracker: Fitbit

Interventions

  • DeviceWireless Activity tracker: Fitbit

    Patients will wear a Fitbit flex

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What researchers measure

Primary outcomes

  1. Activity measured in steps

    Time frame: 1 year delineated by minute

Secondary outcomes

  1. Sleep

    wireless activity will attempt to monitor sleep cycles when the device is worn

    Time frame: per night over 1 year

  2. Quality of Life - SF-36

    SF-36

    Time frame: months 0, 3, 6, 9, and 12

  3. Quality of Life - Fact- Br

    Fact-Br

    Time frame: months 0, 3, 6, 9, and 12

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Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
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References and documents

Individual participant data

Plan to share: No — Individual data will not be shared. De-identified group data will be made available

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02674945
Responsible party
Sponsor
First posted
Feb 5, 2016
Start date
Sep 2014
Primary completion
Sep 2018
Completion
Sep 2018
Last update
Jun 28, 2022

Study contacts

David Darrow, MD MPH
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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