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

June 21, 2022 updated by: University of Minnesota
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.

Study Overview

Status

Terminated

Conditions

Intervention / 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

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Activity measured in steps
Time Frame: 1 year delineated by minute
1 year delineated by minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep
Time Frame: per night over 1 year
wireless activity will attempt to monitor sleep cycles when the device is worn
per night over 1 year
Quality of Life - SF-36
Time Frame: months 0, 3, 6, 9, and 12
SF-36
months 0, 3, 6, 9, and 12
Quality of Life - Fact- Br
Time Frame: months 0, 3, 6, 9, and 12
Fact-Br
months 0, 3, 6, 9, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: David Darrow, MD MPH, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ACTUAL)

September 1, 2018

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (ESTIMATE)

February 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1406M51644
  • #2014NTLS054 (OTHER: CPRC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data will not be shared. De-identified group data will be made available

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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