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Sunface Mirroring RCT in Brazil

Primary Purpose

Skin Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
photoaging mirroring intervention
Sponsored by
University of Giessen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Cancer

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Visiting a secondary school in Brazil.

Exclusion Criteria:

Not visiting a secondary school in Brazil.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    45 minutes seminar on skin cancer prevention and UV-protection in general.

    The control croup takes part in the survey but does not receive an intervention.

    Outcomes

    Primary Outcome Measures

    Change in prevalence of daily sunscreen use at six months
    The difference between daily sunscreen use in the past 30 days in the intervention group from baseline to six months follow-up vs. in the control group from baseline to six months follow-up.
    Change in prevalence of daily sunscreen use at one months
    The difference between daily sunscreen use in the past 30 days in the intervention group from baseline to one months follow-up vs. in the control group from baseline to one month follow-up.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 2, 2017
    Last Updated
    June 2, 2017
    Sponsor
    University of Giessen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03178240
    Brief Title
    Sunface Mirroring RCT in Brazil
    Official Title
    Randomized Trial of a Photoaging Mirroring Intervention for Skin Cancer Prevention in Secondary Schools in Brazil - Study Protocol
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2018 (Anticipated)
    Primary Completion Date
    October 1, 2018 (Anticipated)
    Study Completion Date
    December 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Giessen

    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
    Randomized trial looking at the effects of a behavioral photoaging software intervention on sunscreen use in the city of Itauna, Brazil.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    45 minutes seminar on skin cancer prevention and UV-protection in general.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control croup takes part in the survey but does not receive an intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    photoaging mirroring intervention
    Intervention Description
    selfies of the students are photoaged showing them the consequences of their UV protection behavior on their own face
    Primary Outcome Measure Information:
    Title
    Change in prevalence of daily sunscreen use at six months
    Description
    The difference between daily sunscreen use in the past 30 days in the intervention group from baseline to six months follow-up vs. in the control group from baseline to six months follow-up.
    Time Frame
    6 months
    Title
    Change in prevalence of daily sunscreen use at one months
    Description
    The difference between daily sunscreen use in the past 30 days in the intervention group from baseline to one months follow-up vs. in the control group from baseline to one month follow-up.
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Visiting a secondary school in Brazil. Exclusion Criteria: Not visiting a secondary school in Brazil.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Titus J Brinker
    Phone
    15175084347
    Email
    titus.brinker@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32374352
    Citation
    Brinker TJ, Faria BL, de Faria OM, Klode J, Schadendorf D, Utikal JS, Mons U, Krieghoff-Henning E, Lisboa OC, Oliveira ACC, Lino HA, Bernardes-Souza B. Effect of a Face-Aging Mobile App-Based Intervention on Skin Cancer Protection Behavior in Secondary Schools in Brazil: A Cluster-Randomized Clinical Trial. JAMA Dermatol. 2020 Jul 1;156(7):737-745. doi: 10.1001/jamadermatol.2020.0511.
    Results Reference
    derived
    PubMed Identifier
    29511007
    Citation
    Brinker TJ, Faria BL, Gatzka M, de Faria OM, Heppt MV, Kirchberger MC, Schadendorf D, Nakamura Y, Buslaff F, Lisboa OC, Oliveira ACC, Lino HA, Bernardes-Souza B. A skin cancer prevention photoageing intervention for secondary schools in Brazil delivered by medical students: protocol for a randomised controlled trial. BMJ Open. 2018 Mar 6;8(3):e018299. doi: 10.1136/bmjopen-2017-018299.
    Results Reference
    derived

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    Sunface Mirroring RCT in Brazil

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