NCT02674945

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

4 years

First QC Date

January 4, 2016

Last Update Submit

June 21, 2022

Conditions

Keywords

fitbitactivity trackersleepquality of life

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.

Device: Wireless Activity tracker: Fitbit

Interventions

Patients will wear a Fitbit flex

Wireless Activity tracker: Fitbit

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • David Darrow, MD MPH

    University of Minnesota

    PRINCIPAL INVESTIGATOR

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

Locations