search
Back to results

Test of Interventions to Prevent Skin Cancer Among Danes on Vacation in High UV Index Sunny Destinations

Primary Purpose

Sunburn, Ultraviolet Radiation Exposure, Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Other: Control Group - Minimal Intervention
Experimental: Protection Routine 1
Experimental: Protection Routine 2
Sponsored by
Brian Køster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sunburn focused on measuring Prevention

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Physically or mentally uncapable to complete the planned intervention routines

Sites / Locations

  • Danish Cancer Society

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Experimental

Arm Label

Control Group - Minimal Intervention

Protection Routine 1

Protection Routine 2

Protection Routine 1+2

Arm Description

Minimal intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Awareness of skin cancer risk
determined by questionnaire which is sent within a week after travelling home
Use of sunprotection;shade
determined by questionnaire which is sent within a week after travelling home
Use of sunprotection;clothes
Use of sunprotection;hat
determined by questionnaire which is sent within a week after travelling home
Use of sunprotection;sunscreen
determined by questionnaire which is sent within a week after travelling home
Sunburn body site
determined by questionnaire which is sent within a week after travelling home; relation between relevance of sunprotection and sunburned area
Exposure in UV peak hours
determined by questionnaire which is sent within a week after travelling home

Full Information

First Posted
February 20, 2018
Last Updated
July 16, 2019
Sponsor
Brian Køster
search

1. Study Identification

Unique Protocol Identification Number
NCT03607578
Brief Title
Test of Interventions to Prevent Skin Cancer Among Danes on Vacation in High UV Index Sunny Destinations
Official Title
Test of Developed Interventions to Prevent Skin Cancer: a Randomized Study Targeting Danes Going on Vacation to Sunny Destinations With High UV Index
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
January 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brian Køster

4. Oversight

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

5. Study Description

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).
Detailed Description
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. To achieve the aim of this study we will conduct a randomized controlled trial with four arms during May-Dec 2018. Participants will be Danish adults traveling on vacation in 2018 for a period of 1-3 weeks, recruited from the civil registration system. After enrollment and pretesting, participants will be randomly assigned to one of four experimental conditions. Three experimental groups will receive innovative intervention strategies for promoting sun protection practices during vacation - Protection Routine (1), Protection Routine (2) or both Protection Routine (1+2). The fourth experimental condition will be a minimal treatment control group. The primary outcomes of the trial will be a reduction in frequency of sunburn by adherence to the current sun protection advice from the Danish Cancer Society, i.e., use of shade, hats, protective clothing, and sunscreen as secondary outcomes. We hypothesize that the following two interventions will be able to reduce significantly the UVR exposure and risk of sunburns in Danes going on vacation to destinations with high UVI. The participants of the study are recruited from the Danish civil registration based system. The study population will represent all groups of the Danish population. Eligibility criteria for the project are persons living in Denmark going on vacation in May-December 2018 and having a smartphone compatible with either apple iOS (version 7.0 or newer) or Google Android (version 4.0 or newer). The period May to December is chosen as it includes all types of vacationers. The summer vacation constitutes the majority of the sunny vacations of the Danes. The period includes both the summer, where Danes typically travel to the Mediterranean area and the winter period where travel patterns change a bit to more exotic areas like Thailand, Egypt and the Canarias Islands. Exclusion criteria are persons younger than 18 years of age. Sun protective behavior, exposure to UVR and sunburn will be evaluated by use of a questionnaire validated by personal electronic UV-measurements. This newly developed survey tool has made it possible in this project to evaluate the skin cancer interventions, without tracking of development of skin cancer which can take several years to develop after excessive UVR exposure. The short time period from intervention to evaluation minimizes recall bias. The primary success criteria of the effectiveness of the interventions is a 10 % decrease in sunburn fraction in the intervention groups as compared to the control group in the post-intervention measurement, as shown possible in the pilot study. Furthermore, we aim to reach completion and response rates of 90 % of the total sample Secondary success criteria are increased awareness on the risk of skin cancer, increased use of protection (shade, clothes, hat and sunscreen) and decreased outdoor exposure when the UVI is highest between 12 and 3 pm. For all secondary success criteria, we aim for an improvement of 10 % between interventions and control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sunburn, Ultraviolet Radiation Exposure, Skin Cancer, Malignant Melanoma, Non-melanoma Skin Cancer, Keratinocyte Skin Cancer
Keywords
Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1548 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group - Minimal Intervention
Arm Type
Other
Arm Description
Minimal intervention
Arm Title
Protection Routine 1
Arm Type
Experimental
Arm Title
Protection Routine 2
Arm Type
Experimental
Arm Title
Protection Routine 1+2
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Other: Control Group - Minimal Intervention
Intervention Description
Basic Campaign Folder
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Protection Routine 1
Other Intervention Name(s)
Intensive information and training in current advice - UVI & Skintype
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Protection Routine 2
Other Intervention Name(s)
Thorough sunscreen and availability of hat
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sunburn
Description
Any erythema (selfdetermined by questionnaire which is sent within a week after travelling home)
Time Frame
Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Secondary Outcome Measure Information:
Title
Awareness of skin cancer risk
Description
determined by questionnaire which is sent within a week after travelling home
Time Frame
Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Title
Use of sunprotection;shade
Description
determined by questionnaire which is sent within a week after travelling home
Time Frame
Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Title
Use of sunprotection;clothes
Time Frame
Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Title
Use of sunprotection;hat
Description
determined by questionnaire which is sent within a week after travelling home
Time Frame
Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Title
Use of sunprotection;sunscreen
Description
determined by questionnaire which is sent within a week after travelling home
Time Frame
Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Title
Sunburn body site
Description
determined by questionnaire which is sent within a week after travelling home; relation between relevance of sunprotection and sunburned area
Time Frame
Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Title
Exposure in UV peak hours
Description
determined by questionnaire which is sent within a week after travelling home
Time Frame
Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Physically or mentally uncapable to complete the planned intervention routines
Facility Information:
Facility Name
Danish Cancer Society
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Test of Interventions to Prevent Skin Cancer Among Danes on Vacation in High UV Index Sunny Destinations

We'll reach out to this number within 24 hrs