Condition category
Signs and Symptoms
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
In light of increasing skin cancer incidences worldwide, preventive measures to promote sun protection in individuals with risky sun habits have continued relevance and importance. The efficacy of tailored sun protection advice has been studied in different settings, with varying results, of which primary care is one important provider previously identified. However, evidence on long-term sustainability of the effect of such advice given is lacking.
Aim: To report the long-term effect of individualised sun protection advice given in primary healthcare (PHC), on sun habits/sun protection behaviour, and attitudes towards sunbathing.

Who can participate?
Patients > 18 years of age visiting the study primary health care centre during the recruitment period.

What does the study involve?
All participant completed a questionnaire mapping sun habits and attitudes towards sunbathing, and were then randomised to three possible interventions: 1) Individualised, written sun protection advice, 2) Individualised sun protection advice mediated orally by a GP, and 3) Individualised sun protection advice mediated orally by a GP and performance of a skin phototest for assessment of individual ultraviolet skin sensitivity.

What are the possible benefits and risks of participating?
All participants were given individualised sun protection advice based on their personal risk profile with regard to skin cancer, advice that in case followed, would be likely to be beneficial in terms of reducing ultraviolet exposure risks, or at least lead to increased awareness. Since the intervention did not include any kind of invasive, sensitive or integrity intruding elements, there was no obvious risk for the participants for taking part in the study. The phototest performed in one of the intervention groups comprised the illumination of ultraviolet radiation on very small, well-defined skin areas, insufficient to cause any harm or increased skin cancer risk.

Where is the study run from?
Kärna Primary Healthcare centre, Linköping, Sweden

When is the study starting and how long is it expected to run for?
February 2005 for 3 weeks

Who is funding the study?
Region Östergötland, Sweden

Who is the main contact?
Dr Magnus Falk (scientific contact),

Trial website

Contact information



Primary contact

Dr Magnus Falk


Contact details

Dept of Medical & Health Sciences
Linkoping University
581 83
+46 13 28 69 39

Additional identifiers

EudraCT number

Nil known number

Nil known

Protocol/serial number


Study information

Scientific title

Skin cancer prevention in primary care - a randomised study


Study hypothesis

1. Sun protection advice given in a primary care setting is more effective in reducing individual ultraviolet exposure if mediated orally by a general practitioner in comparison with solely written information.
2. Addition of an ultraviolet photo test to the oral information contributes to reinforce the sun protection advice given.

Ethics approval

Approved 15/12/2004, The Regional Ethical Review Board in Linköping (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden;; +4610-475 08 00) ref: Dnr. M187-04.

Study design

Single center Interventional randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

See additional file


Sun exposure habits with regard to skin cancer


The participants were consecutively computer-randomised to the three intervention groups, at registration in the reception of the healthcare centre. All participants completed a questionnaire mapping sun exposure habits, attitudes towards sunbathing and propensity to increase sun protection.
Interventions given:
All groups: A brief written, general sun protection advice information sheet.
Group 1: Written, individualised sun protection advice based on the questionnaire responses, mediated in letter-form.
Group 2: Individualised sun protection advice based on the questionnaire responses, mediated orally in the form of a personal GP’s consultation, taking approximately 20 minutes, including a nevi check.
Group 3: The corresponding intervention as in Group 2 but also including a skin phototest for estimation of individual ultraviolet sensitivity with feedback of the test outcome.

Intervention type



Drug names

Primary outcome measure

Sun exposure habits, measured by a questionnaire based of a number of 5-grade Likert scored question, reflecting frequency and degree of sun exposure and protection, and five questions measuring propensity to increase sun protection based on the transtheoretical model of behaviour change. Measurement time points: Baseline (at study start, prior to intervention), after 6 months, 3 years and 10 years.

Secondary outcome measures

Secondary outcome variable: Attitudes towards sunbathing, measured by a number of 5-grade Likert scored questions. Measurement time points: Baseline (at study start, prior to intervention), after 6 months, 3 years and 10 years.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Patients > 18 years of age visiting the study primary health care centre during the recruitment period.

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Abnormal UV-sensitivity
2. Intake of UV-sensitising medication
3. Cognitive impairment

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Kärna Primary Healthcare centre
Kärnabrunnsgatan 10

Sponsor information


County Council of Östergötland

Sponsor details

Region Östergötland

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Länsstyrelsen Östergötland

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Half-year results were published in 2008, 3-year results in 2011. 10-year results are intended to be published in 2019.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

2008 results in:
2011 results in:

Publication citations

Additional files

Editorial Notes

23/05/2019: The participant information sheet was uploaded. 24/04/2019: Trial’s existence confirmed by The Regional Ethical Review Board in Linköping