Understanding and Improving Quality of Life Through a Wir... | NCT02674945

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

NCT02674945

Sponsor

University of Minnesota

Status

Terminated

Last Update Posted

Jun 28, 2022Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Brain Tumor

Interventions

Wireless Activity tracker: Fitbit

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
#2014NTLS054	Other Identifier	CPRC

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low enrollment, unable to power adequately

Expanded Access Info

Start Date

Sep 2014Actual

Primary Completion Date

Sep 2018Actual

Completion Date

Sep 2018Actual

First Submitted Date

Jan 4, 2016

First Submission Date that Met QC Criteria

Feb 2, 2016

First Posted Date

Feb 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2022

Last Update Posted Date

Jun 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Wireless Activity tracker: Fitbit	Device	Patients will wear a Fitbit flex	Wireless Activity tracker: Fitbit

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Sleep	wireless activity will attempt to monitor sleep cycles when the device is worn	per night over 1 year
Quality of Life - SF-36	SF-36

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Darrow, MD MPH	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided