SunburnNCT03607578
Test of Interventions to Prevent Skin Cancer Among Danes on Vacation in High UV Index Sunny Destinations
A study testing Experimental: Protection Routine 1 and Experimental: Protection Routine 2 in people with Sunburn and Ultraviolet Radiation Exposure, run by Brian Køster at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunburn, Ultraviolet Radiation Exposure, Skin Cancer
- What is being tested?
- Experimental: Protection Routine 1 and Experimental: Protection Routine 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,548 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2018to 11 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Physically or mentally uncapable to complete the planned intervention routines
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Sunburn, Ultraviolet Radiation Exposure, Skin Cancer, Malignant Melanoma, Non-melanoma Skin Cancer, Keratinocyte Skin Cancer
- Being tested
- Other: Control Group - Minimal Intervention, Experimental: Protection Routine 1, Experimental: Protection Routine 2
- Keywords
- Prevention
- Medical subject headings
- Sunburn, Skin Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Control Group - Minimal InterventionBehavioural
Basic Campaign Folder
Experimental: Protection Routine 1Behavioural
Also called Intensive information and training in current advice - UVI & Skintype
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.
Experimental: Protection Routine 2Behavioural
Also called Thorough sunscreen and availability of hat
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group - Minimal Intervention | Other | Minimal intervention Receives: Behavioral: Other: Control Group - Minimal Intervention |
| Protection Routine 1 | Experimental | Not described Receives: Behavioral: Experimental: Protection Routine 1 |
| Protection Routine 2 | Experimental | Not described Receives: Behavioral: Experimental: Protection Routine 2 |
| Protection Routine 1+2 | Experimental | Not described Receives: Behavioral: Experimental: Protection Routine 1; Behavioral: Experimental: Protection Routine 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sunburn
Any erythema (selfdetermined by questionnaire which is sent within a week after travelling home)
Measured: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Secondary outcomes (7)
Awareness of skin cancer risk
determined by questionnaire which is sent within a week after travelling home
Measured: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Use of sunprotection;shade
determined by questionnaire which is sent within a week after travelling home
Measured: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Use of sunprotection;clothes
Measured: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Use of sunprotection;hat
determined by questionnaire which is sent within a week after travelling home
Measured: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Use of sunprotection;sunscreen
determined by questionnaire which is sent within a week after travelling home
Measured: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Sunburn body site
determined by questionnaire which is sent within a week after travelling home; relation between relevance of sunprotection and sunburned area
Measured: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Exposure in UV peak hours
determined by questionnaire which is sent within a week after travelling home
Measured: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Aug 2018
- Primary completion11 Jan 2019
- Study completion11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SunburnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,548 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian Køster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian Køster, Danish Cancer Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607578
- Sponsor's protocol ID
- RCT429-2015-294
- Status last verified
- Jul 2019
- First submitted
- 20 Feb 2018
- Last updated
- 17 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03607578
- Acronym / sponsor ID
- RCT429-2015-294
- Conditions
- Sunburn, Ultraviolet Radiation Exposure, Skin Cancer, Malignant Melanoma, Non-melanoma Skin Cancer, Keratinocyte Skin Cancer
- Keywords
- Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,548 participants (actual)
- Lead sponsor
- Brian KøsterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group - Minimal Intervention | Other | Behavioral: Other: Control Group - Minimal InterventionMinimal 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 1, Behavioral: Experimental: Protection Routine 2 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Physically or mentally uncapable to complete the planned intervention routines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other: Control Group - Minimal InterventionBasic Campaign Folder | Behavioural | Control Group - Minimal Intervention |
| Experimental: Protection Routine 1Also: Intensive information and training in current advice - UVI & SkintypeNew 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. | Behavioural | Protection Routine 1, Protection Routine 1+2 |
| Experimental: Protection Routine 2Also: Thorough sunscreen and availability of hatThe 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. | Behavioural | Protection Routine 1+2, Protection Routine 2 |
Primary outcome
Sunburn
Time frame: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Any erythema (selfdetermined by questionnaire which is sent within a week after travelling home)
7 secondary outcomes
Awareness of skin cancer risk
Time frame: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Use of sunprotection;shade
Time frame: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Use of sunprotection;clothes
Time frame: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Use of sunprotection;hat
Time frame: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Use of sunprotection;sunscreen
Time frame: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Sunburn body site
Time frame: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Exposure in UV peak hours
Time frame: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Sunburn
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Randomized Trial of a Sun Safety Intervention for Young Adults
Sunburn
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Undergraduate Skin Cancer Prevention Trial
Skin Cancer
Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Protection Routine 1 and Experimental: Protection Routine 2 in people with Sunburn and Ultraviolet Radiation Exposure, run by Brian Køster at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sunburn (time frame: Experienced during participants vacationperiod (1-3 weeks within may-dec 2018)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.