Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors

April 15, 2019 updated by: University of Minnesota
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Microsoft Band 2 application with UV messaging activated
Device: Microsoft Band 2 + UV messaging
wearable device (wrist) and associated mobile application; UV sensor and messaging activated
Active Comparator: Control
Microsoft Band 2 application (UV messaging not active)
Device: Microsoft Band 2
wearable device (wrist) and associated mobile application; UV messaging not activated

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Melanoma Research Alliance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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