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NCT02674945 Clinical Trial

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

Brain Tumor Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02674945
Other study ID # 1406M51644
Secondary ID #2014NTLS054
Status Terminated
Phase
First received
Last updated
Start date September 2014
Est. completion date September 2018

Study information
Verified date June 2022
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 29
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Wireless Activity tracker: Fitbit
Patients will wear a Fitbit flex

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Activity measured in steps 1 year delineated by minute
Secondary Sleep wireless activity will attempt to monitor sleep cycles when the device is worn per night over 1 year
Secondary Quality of Life - SF-36 SF-36 months 0, 3, 6, 9, and 12
Secondary Quality of Life - Fact- Br Fact-Br months 0, 3, 6, 9, and 12
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