NCT03607578

Brief Summary

The aim of the study is to test a series of developed effective interventions targeting Danes going on vacation to sunny destinations to decrease sunburn by increasing use of shade, hats, protective clothing, and sunscreen to prevent skin cancer in the Danish population. It has been estimated that up to 90 % of all skin cancers could be avoided by behavioral changes. One of the main sources of UVR exposure in the Danish population is vacations to destinations with high UV index (UVI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,548

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2019

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

February 20, 2018

Last Update Submit

July 16, 2019

Conditions

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

  • Sunburn

    Any erythema (selfdetermined by questionnaire which is sent within a week after travelling home)

    Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)

Secondary Outcomes (7)

  • Awareness of skin cancer risk

    Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)

  • Use of sunprotection;shade

    Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)

  • Use of sunprotection;clothes

    Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)

  • Use of sunprotection;hat

    Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)

  • Use of sunprotection;sunscreen

    Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)

  • +2 more secondary outcomes

Study Arms (4)

Control Group - Minimal Intervention

OTHER

Minimal intervention

Behavioral: Other: Control Group - Minimal Intervention

Protection Routine 1

EXPERIMENTAL
Behavioral: Experimental: Protection Routine 1

Protection Routine 2

EXPERIMENTAL
Behavioral: Experimental: Protection Routine 2

Protection Routine 1+2

EXPERIMENTAL
Behavioral: Experimental: Protection Routine 1Behavioral: Experimental: Protection Routine 2

Interventions

Basic Campaign Folder

Control Group - Minimal Intervention

New folder, sun advice of Danish Sun Safety Campaign, rationale, prioritization, overview of sun prevention. Activity planner with outdoor activities like bathing, sports and excursions before and after noon (UVI maximum) and indoor activities; shopping, lunch, relaxation and transportation in middle of day and possibility to plan vacation to minimize risk. Instructions for download of UV-App includes use of alert, and information about the features of the app; how to be informed of current UV risk before and during vacation. Link for download of the app is sent by text-message and e-mail. Skintype guide is included in the app and as an individual entity. It includes scoring questions about tan and burn reaction in the sun, a color scale, eye and hair color and freckles. Participants get a description of their skin type and examples of time their particular skin type will resist the sun before erythema occurs at particular UV-levels and functions as an eye-opener.

Also known as: Intensive information and training in current advice - UVI & Skintype
Protection Routine 1Protection Routine 1+2

The sunscreen application instruction is based on a recently developed thorough application instructions for use of sunscreen to counter the problems and deficits of current sunscreen use. It describes every part of the body, the needed volume for that part and application patterns. The package will also include a hat specifically designed for protection and comfort and the availability of a hat will function to increase the use of hat. The hat is simple bucket hat version with a brim, cheap, in light fabric and foldable for easy packing.

Also known as: Thorough sunscreen and availability of hat
Protection Routine 1+2Protection Routine 2

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Travel for a vacation to a location with higher UVI than Denmark in the trial period (May-December 2018)
  • Access to a smartphone compatible with either iOS (version 7 or newer) or Google Android ( version 4.0 or newer)

You may not qualify if:

  • Physically or mentally uncapable to complete the planned intervention routines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Cancer Society

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

SunburnSkin NeoplasmsMelanoma

Condition Hierarchy (Ancestors)

Photosensitivity DisordersSkin DiseasesSkin and Connective Tissue DiseasesBurnsWounds and InjuriesNeoplasms by SiteNeoplasmsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and Melanomas

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research scientist

Study Record Dates

First Submitted

February 20, 2018

First Posted

July 31, 2018

Study Start

August 1, 2018

Primary Completion

January 11, 2019

Study Completion

January 11, 2019

Last Updated

July 17, 2019

Record last verified: 2019-07

Locations