Condition category
Signs and Symptoms
Date applied
23/04/2019
Date assigned
26/04/2019
Last edited
23/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.regionostergotland.se

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

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