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Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors

Primary Purpose

Melanoma (Skin)

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microsoft Band 2 + UV messaging
Microsoft Band 2
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melanoma (Skin) focused on measuring cancer prevention, sunburn

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    Microsoft Band 2 application with UV messaging activated

    Microsoft Band 2 application (UV messaging not active)

    Outcomes

    Primary Outcome Measures

    Sunburn
    Self-report of a sunburn during study period

    Secondary Outcome Measures

    Full Information

    First Posted
    April 25, 2018
    Last Updated
    April 15, 2019
    Sponsor
    University of Minnesota
    Collaborators
    Melanoma Research Alliance
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03518229
    Brief Title
    Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors
    Official Title
    Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Converted from a pilot into a larger study which we will enter as a new protocol
    Study Start Date
    February 2020 (Anticipated)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    May 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Minnesota
    Collaborators
    Melanoma Research Alliance

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melanoma (Skin)
    Keywords
    cancer prevention, sunburn

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Microsoft Band 2 application with UV messaging activated
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Microsoft Band 2 application (UV messaging not active)
    Intervention Type
    Device
    Intervention Name(s)
    Microsoft Band 2 + UV messaging
    Intervention Description
    wearable device (wrist) and associated mobile application; UV sensor and messaging activated
    Intervention Type
    Device
    Intervention Name(s)
    Microsoft Band 2
    Intervention Description
    wearable device (wrist) and associated mobile application; UV messaging not activated
    Primary Outcome Measure Information:
    Title
    Sunburn
    Description
    Self-report of a sunburn during study period
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors

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