We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02674945
Recruitment Status : Terminated (Low enrollment, unable to power adequately)
First Posted : February 5, 2016
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Brain Tumor Device: Wireless Activity tracker: Fitbit

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase
Actual Study Start Date : September 2014
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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
Patients will wear a Fitbit flex


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Activity measured in steps [ Time Frame: 1 year delineated by minute ]

Secondary Outcome Measures :
  1. Sleep [ Time Frame: per night over 1 year ]
    wireless activity will attempt to monitor sleep cycles when the device is worn

  2. Quality of Life - SF-36 [ Time Frame: months 0, 3, 6, 9, and 12 ]
    SF-36

  3. Quality of Life - Fact- Br [ Time Frame: months 0, 3, 6, 9, and 12 ]
    Fact-Br


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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:

  • unable to provide consent
  • age < 18
  • lack of use of the wireless activity tracker for more than 2 consecutive months
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02674945


Locations
Layout table for location information
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
Layout table for investigator information
Principal Investigator: David Darrow, MD MPH University of Minnesota
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02674945    
Other Study ID Numbers: 1406M51644
#2014NTLS054 ( Other Identifier: CPRC )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be shared. De-identified group data will be made available
Keywords provided by University of Minnesota:
fitbit
activity tracker
sleep
quality of life