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), magnus.falk@liu.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Magnus Falk
ORCID ID
http://orcid.org/0000-0001-6688-3860
Contact details
Dept of Medical & Health Sciences
Linkoping University
Linköping
581 83
Sweden
+46 13 28 69 39
magnus.falk@liu.se
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
LIO-14711
Study information
Scientific title
Skin cancer prevention in primary care - a randomised study
Acronym
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; registrator@etikprovning.se; +4610-475 08 00) ref: Dnr. M187-04.
Study design
Single center Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
See additional file
Condition
Sun exposure habits with regard to skin cancer
Intervention
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
Behavioural
Phase
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
01/09/2004
Overall trial end date
30/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients > 18 years of age visiting the study primary health care centre during the recruitment period.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Total final enrolment
316
Participant exclusion criteria
1. Abnormal UV-sensitivity
2. Intake of UV-sensitising medication
3. Cognitive impairment
Recruitment start date
01/02/2005
Recruitment end date
25/02/2005
Locations
Countries of recruitment
Sweden
Trial participating centre
Kärna Primary Healthcare centre
Kärnabrunnsgatan 10
Linköping
58662
Sweden
Sponsor information
Organisation
County Council of Östergötland
Sponsor details
Region Östergötland
Linköping
58185
Sweden
+46101030000
anna-lena.nylander@regionostergotland.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Länsstyrelsen Östergötland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
01/06/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/18802808
2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21682578
Publication citations
Additional files
- ISRCTN99837874_PIS_24Apr2019.pdf Uploaded 23/05/2019