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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

Tracking Information
First Submitted Date January 4, 2016
First Posted Date February 5, 2016
Last Update Posted Date June 28, 2022
Actual Study Start Date September 2014
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 2, 2016)		 Activity measured in steps [ Time Frame: 1 year delineated by minute ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 2, 2016)
  • Sleep [ Time Frame: per night over 1 year ]
    wireless activity will attempt to monitor sleep cycles when the device is worn
  • Quality of Life - SF-36 [ Time Frame: months 0, 3, 6, 9, and 12 ]
    SF-36
  • Quality of Life - Fact- Br [ Time Frame: months 0, 3, 6, 9, and 12 ]
    Fact-Br
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase
Official Title Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Consentable patients suffering from a single or multiple primary or metastatic brain tumors
Condition Brain Tumor
Intervention Device: Wireless Activity tracker: Fitbit
Patients will wear a Fitbit flex
Study Groups/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.
Intervention: Device: Wireless Activity tracker: Fitbit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 18, 2019)		 29
Original Estimated Enrollment
 (submitted: February 2, 2016)		 75
Actual Study Completion Date September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02674945
Other Study ID Numbers 1406M51644
#2014NTLS054 ( Other Identifier: CPRC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Individual data will not be shared. De-identified group data will be made available
Current Responsible Party University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor University of Minnesota
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: David Darrow, MD MPH University of Minnesota
PRS Account University of Minnesota
Verification Date June 2022