Study Stopped
Low enrollment, unable to power adequately
Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase
2 other identifiers
observational
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 4, 2016
CompletedFirst Posted
Study publicly available on registry
February 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJune 28, 2022
June 1, 2022
4 years
January 4, 2016
June 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Activity measured in steps
1 year delineated by minute
Secondary Outcomes (3)
Sleep
per night over 1 year
Quality of Life - SF-36
months 0, 3, 6, 9, and 12
Quality of Life - Fact- Br
months 0, 3, 6, 9, and 12
Study Arms (1)
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.
Interventions
Patients will wear a Fitbit flex
Eligibility Criteria
Consentable patients suffering from a single or multiple primary or metastatic brain tumors
You may qualify if:
- diagnosed with primary or metastatic brain tumor
- able to wear wireless activity tracker
- able to complete QOL and sleep surveys every 3 months
You may not qualify if:
- unable to provide consent
- age \< 18
- lack of use of the wireless activity tracker for more than 2 consecutive months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Darrow, MD MPH
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2016
First Posted
February 5, 2016
Study Start
September 1, 2014
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
June 28, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share
Individual data will not be shared. De-identified group data will be made available