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

Terminated

• Conditions: Brain Tumor

• Registration Number: NCT02674945
• Lead Sponsor: University of Minnesota

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-05
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

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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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Activity measured in steps	1 year delineated by minute

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States