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), firstname.lastname@example.org
Skin cancer prevention in primary care - a randomised study
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.
Approved 15/12/2004, The Regional Ethical Review Board in Linköping (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; email@example.com; +4610-475 08 00) ref: Dnr. M187-04.
Single center Interventional randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
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.
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.
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.
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
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)
- ISRCTN99837874_PIS_24Apr2019.pdf Uploaded 23/05/2019