Condition category
Cancer
Date applied
27/02/2020
Date assigned
09/03/2020
Last edited
06/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
SUNsitive is an online application (app) that allows user to enter information relevant for their skin health (through an online questionnaire) and then uses that information to give a tailored online feedback on melanoma risk, overall skin health and skin appearance (including tobacco use effects) and advice on reducing any form of skin damage.

The main aim of the SUNsitive study is to explore whether the app can improve people's intentions to protect themselves from the sun. It additionally aims to see whether it improves people's self-belief in protecting themselves, their beliefs and attitudes about tanning (indoor and outdoor), and their smoking status. Furthermore, SUNsitive aims to explore the experiences and satisfaction of users with the app.

Who can participate?
German speakers who are aged 18 years or older, provide consent to the study and have no current or previous skin cancer.

What does the study involve?
Participants will be recruited in the waiting room of the travel clinic of the University of Zurich (UZH Zentrum für Reisemedizin). Upon entering the waiting room, potential participants will be informed about the study and asked if they voluntarily would like to take part. Those who volunteer and fulfill all participation criteria will be informed in detail about the study and asked to provide their written consent.

Each participant will then be allocated to one of two groups. One group will have full access to the app (including the online questionnaire and online feedback). The other group will only have access to the online questionnaire. The app will be accessed via a tablet.

Participants will then register into the SUNsitive app and either only answer the online questionnaire or answer the questionnaire and receive the online tailored advice about skin health. The feedback will be based on the answers provided by the participant in the questionnaire.

One week later, participants in the full access group will receive a reminder email, asking them to access the SUNsitive app from home and to read the advice and feedback given on the app again.

Two weeks after participation, both groups will again receive the questionnaires through the app, which they will have to answer again in order to see whether any changes occurred.

What are the possible benefits and risks of participating?
SUN-sitive will contribute towards a much needed and targeted increase in awareness around sun protection, melanoma prevention, skin health and the linkages between tobacco consummation and the skin. Based on previous research, it is expected that SUN-sitive exposure will impact individual attitudes towards tanning and UV-ray exposing behavior, which is a strong predictor for actual behavior.

This trial can be categorized involves minimal risk or burden. SUNsitive is non-invasive, does not target a vulnerable population and is not expected to cause any discomfort or burden.

Providing information on risks and dangers (which SUNsitive will do through its feedback modules) always carries a risk to cause individual concern or worry. SUN-sitive will counteract that by using clear, non-emotional language, based on facts and evidence, allowing for questions and concerns to be discussed with the healthcare provider during the consultation, and allowing for questions and concerns to be directly discussed during SUN-sitive exposure with a member of the team. Part of the preventive feedback will be an estimation of melanoma risk, based on a validated score. We will ensure that the participants are informed that this risk score is only estimated and that it strongly depends on the accuracy of the provided information.

Where is the study run from?
University of Zurich Travel Clinic (Switzerland)

When is the study starting and how long is it expected to run for?
April 2020 to November 2020

Who is funding the study?
The Béatrice Ederer-Weber Foundation (Switzerland) and the University of Zurich Digital Society Initiative (Switzerland)

Who is the main contact?
Mr Vasileios Nittas
vasileios.nittas@uzh.ch

Trial website

Contact information

Type

Scientific

Primary contact

Prof Milo Puhan

ORCID ID

https://orcid.org/0000-0003-4721-1879

Contact details

Hirschengraben 84
Zurich
8001
Switzerland
+41 44 634 46 10
miloalan.puhan@uzh.ch

Type

Scientific

Additional contact

Dr Margot Mütsch

ORCID ID

https://orcid.org/0000-0003-0620-5376

Contact details

Hirschengraben 84
Zurich
8001
Switzerland
+41 44 63 44857
margot.muetsch@uzh.ch

Type

Scientific

Additional contact

Mr Vasileios Nittas

ORCID ID

Contact details

Hirschengraben 84
Zurich
8001
Switzerland
+41 44 63 44946
vasileios.nittas@uzh.ch

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

N/A

Study information

Scientific title

Assessing the Effects of Digital Skin Health Promotion and Sun Protection Advice: The SUNsitive Project

Acronym

SUNsitive

Study hypothesis

Exposure to SUNsitive (sun protection and skin health promotion web application) will increase participant intentions to protect their skin from UV-radiation

Ethics approval

An ethics approval was requested by the Cantonal Ethics Committee Zurich and was waived as the research project does not fall within the scope of the Human Research Act (HRA)

Study design

Single-centre, two-arm randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Sun protection, melanoma prevention, skin health promotion, including awareness of tobacco effects on skin health

Intervention

Participants will be randomized, in a ratio of 1:1, into one of two arms, the intervention group or the control group, using an online research randomization software.

The intervention group will receive access to a web-based app providing tailored sun protection, melanoma prevention, and skin health promotion advice, following the completion of a survey at recruitment (baseline). The same survey will also be completed at follow-up (after two weeks).

The control group will receive care as usual and will also answer the same surveys at baseline and two weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Sun protection intentions measured by a 16-item questionnaire (adapted from Mahler, H.I.M., Kulik, J.A., Gerrard, M., & Gibbons, F. X. (2010). Effects of upward and downward social comparison information on the efficacy of an appearance-based sun protection intervention: A randomized, controlled experiment. Journal of Behavioral Medicine), at baseline and 2 weeks

Secondary outcome measures

1. Self-efficacy to sun protect measured by a 6-item questionnaire (adapted from Babbin, S. F., Yin, H. Q., Rossi, J. S., Redding, C. A., Paiva, A. L., & Velicer, W. F. (2015). Reducing sun exposure for prevention of skin cancers: factorial invariance and reliability of the self-efficacy scale for sun protection. Journal of skin cancer, 2015), at baseline and 2 weeks
2. Attitudes towards tanning measured by a 6-item questionnaire (adapted from Mahler, H. I., Kulik, J. A., Gerrard, M., & Gibbons, F. X. (2010). Effects of upward and downward social comparison information on the efficacy of an appearance-based sun protection intervention: a randomized, controlled experiment. Journal of Behavioral Medicine, 33(6), 496-507), at baseline and 2 weeks
3. Solarium use intentions measured by a 2-item questionnaire (adapted from Heckman, C. J., Manne, S. L., Kloss, J. D., Bass, S. B., Collins, B., & Lessin, S. R. (2011). Beliefs and intentions for skin protection and UV exposure in young adults. American journal of health behavior, 35(6), 699-711), at baseline and 2 weeks
4. Smoking status measured by a 7-item questionnaire (adapted from Etter, J. F., & Sutton, S. (2002). Assessing ‘stage of change’in current and former smokers. Addiction, 97(9), 1171-1182), at baseline and 2 weeks
5. Feasibility and Usability of the SUNsitive application measured by a questionnaire designed by the investigators at 2 weeks

Overall trial start date

01/03/2019

Overall trial end date

31/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥18 years
2. Good understanding of German
3. Able to independently provide informed consent

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

130

Participant exclusion criteria

1. Previous or current skin cancer diagnosis
2. Prescription of doxycycline during travel medicine consultation (assessed post-consultation)

Recruitment start date

23/03/2020

Recruitment end date

30/09/2020

Locations

Countries of recruitment

Switzerland

Trial participating centre

University of Zurich Travel Clinic
Hirschengraben 84
Zurich
8001
Switzerland

Sponsor information

Organisation

University of Zurich

Sponsor details

Epidemiology
Biostatistics and Prevention Institute
Hirschengraben 84
Zurich
8001
Switzerland
+41 44 634 46 11
vasileios.nittas@uzh.ch

Sponsor type

University/education

Website

https://www.ebpi.uzh.ch/en.html

Funders

Funder type

University/education

Funder name

Béatrice Ederer-Weber Stiftung

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Universität Zürich

Alternative name(s)

University of Zurich, UZH

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Switzerland

Results and Publications

Publication and dissemination plan

Our results will be published in peer-reviewed scientific journals, in the field of digital health.

IPD Sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/03/2020: Trial’s existence confirmed by the Cantonal Ethics Committee Zurich.