Skin cancer prevention in primary care
| ISRCTN | ISRCTN99837874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99837874 |
| Secondary identifying numbers | LIO-14711 |
- Submission date
- 23/04/2019
- Registration date
- 26/04/2019
- Last edited
- 12/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
Dept of Medical & Health Sciences
Linkoping University
Linköping
581 83
Sweden
 ORCID ID |
0000-0001-6688-3860 |
|---|---|
| Phone | +46 13 28 69 39 |
| magnus.falk@liu.se |
Study information
| Study design | Single center Interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | ISRCTN99837874_PIS_24Apr2019.pdf |
| Scientific title | Skin cancer prevention in primary care - a randomised study |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2004 |
| Completion date | 30/10/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 316 |
| Key inclusion criteria | 1. Patients > 18 years of age visiting the study primary health care centre during the recruitment period. |
| Key exclusion criteria | 1. Abnormal UV-sensitivity 2. Intake of UV-sensitising medication 3. Cognitive impairment |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 25/02/2005 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Linköping
58662
Sweden
Sponsor information
Hospital/treatment centre
Region Östergötland
Linköping
58185
Sweden
| Phone | +46101030000 |
|---|---|
| anna-lena.nylander@regionostergotland.se | |
| Website | www.regionostergotland.se |
"ROR" |
https://ror.org/0326gsy75 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No | |
| Results article | results | 01/09/2011 | Yes | No | |
| Participant information sheet | 24/04/2019 | 23/05/2019 | No | Yes | |
| Results article | 10 year follow up | 01/10/2019 | 12/06/2023 | Yes | No |
Additional files
- ISRCTN99837874_PIS_24Apr2019.pdf
- Uploaded 23/05/2019
Editorial Notes
12/06/2023: Publication reference added.
23/05/2019: The participant information sheet was uploaded.
24/04/2019: Trial’s existence confirmed by The Regional Ethical Review Board in Linköping
