Pilot Study of Intervention to Reduce Sunburns in Melanom... | NCT03518229

Studies
Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors

NCT03518229

Sponsor

University of Minnesota

Status

Withdrawn

Last Update Posted

Apr 17, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Melanoma (Skin)

Interventions

Microsoft Band 2 + UV messaging
Microsoft Band 2

Countries

Not provided

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

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Converted from a pilot into a larger study which we will enter as a new protocol

Expanded Access Info

Start Date

Feb 2020Estimated

Primary Completion Date

Sep 2020Estimated

Completion Date

May 2021Estimated

First Submitted Date

Apr 25, 2018

First Submission Date that Met QC Criteria

May 7, 2018

First Posted Date

May 8, 2018Actual

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

Apr 15, 2019

Last Update Posted Date

Apr 17, 2019Actual

Name	Class
Melanoma Research Alliance	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 will pilot test whether a wearable device that tracks sun exposure and provides alerts regarding sun exposure and protection behaviors will reduce sunburns in melanoma survivors. The use of wearable technology devices has grown quickly over the last decade and studies using these devices to promote physical activity and weight loss have been promising. The investigators will pilot test the technology device versus a similar control device in 80 melanoma survivors and compare sunburns between the two groups after the three month intervention.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Microsoft Band 2 application with UV messaging activated	Device: Microsoft Band 2 + UV messaging
Control	Active Comparator	Microsoft Band 2 application (UV messaging not active)	Device: Microsoft Band 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microsoft Band 2 + UV messaging	Device	wearable device (wrist) and associated mobile application; UV sensor and messaging activated	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sunburn	Self-report of a sunburn during study period	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-75 years old
Diagnosed with stage I-III cutaneous invasive melanoma between 2009 and 2017 and treated at the University of Minnesota
Able to read/write in English
Own a smartphone
Able to provide voluntary informed consent

Exclusion Criteria:

-Patients currently undergoing adjuvant therapy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma
D013471	Sunburn

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided