Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001187235
Ethics application status
Approved
Date submitted
10/07/2018
Date registered
17/07/2018
Date last updated
20/06/2019
Date data sharing statement initially provided
19/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Technology to stop skin cancer: can new technology improve sun protection behaviours in organ transplant recipients?
Scientific title
Technology to stop skin cancer: a feasibility study testing an app to improve sun protection behaviours in organ transplant recipients in Australia.
Secondary ID [1] 295262 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sunburn 308433 0
sun exposure 308434 0
Condition category
Condition code
Public Health 307419 307419 0 0
Health promotion/education
Cancer 307420 307420 0 0
Non melanoma skin cancer
Cancer 307421 307421 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this feasibility study is to make engaging sun protection health messages and test them in organ transplant recipients. Organ transplant recipients have an 80 per cent higher risk of skin cancer due to the immune system suppressing medication they must take for life. We have constructed a Gold coast specific version of the SunVisor app for smartphones, tablets and smartwatches to provide sun-protective messages to athletes and spectators at the Australian Transplant Games 2018 on the Gold Coast, Queensland Sept 30-Oct 06 2018. Friends, family and spectators (general population group) at the event are also encouraged to participate, as sun safety is important for everyone in a high UV environment such as Queensland. The SunVisor app will broadcast real-time-weather data, including temperature, humidity, and UV level. Personalised messages (via push notifications) will be delivered through the app with the aim to decrease risk of sunburn and allow people spending time outdoors to adequately prepare and respond to conditions.

This is a 1-arm intervention. We will explore if the impact of the intervention differs for sub-groups (transplant recipients, and general population).

Arm 1:
To enrol in the project, interested participants can enrol prior to attending the games, or researchers will be recruiting at the venue where the Games are being held.

The study will be advertised to the public and members of Transplant Australia prior to the event in member newsletters and social media. Interested participants must first contact the research team and they will be sent an online participant information and consent form, asked to confirm consent online (tick box) and proceed to complete a 10-15 minute baseline survey. The baseline survey will ask demographic details, skin type, and regular sun protection practices.

If participants do not enrol prior to the event, research staff will be at the Australian Transplant Games recruiting attendees. Participants will be screened by the staff prior to enrolment. Participants undertake a 5 – 10 minute information enrolment process. Consent will involve handing out the information sheet to interested participants at the venue. The researchers will allow adequate time for participants to read the information sheet, ask questions and discuss elements of the project.

All participants who enrol will be provided with a free tube of sunscreen after the baseline survey is complete and the app is on the participants’ smartphone (tube 35ml, 30 + SPF Cancer Council Brand). Participants who enrol prior to the event can collect their sunscreen at the event by providing their full name.

Once the baseline survey is completed online (either prior to the event or at the event), all participants will be directed to download the app (called the SunVisor app). The participants will be asked to use the app at the Australian Transplant Games. Participants will be asked to go about their everyday activities whilst using the app, and engage in the app as they see fit. They are asked to use the app for 7 days both at the Transplant Games or during any outdoor activity at peak UV times.

Participants will be asked to allow push notifications, so they receive the daily messages. Participants will receive one message a day for the one week intervention period, but can use the app as many times as they like to use its core weather functions. The SunVisor app features a prediction tool that gives transplant recipients a speedometer of risk calculation indicating at any particular moment the amount of sun exposure they would receive.

During the install process questions will be used to allocate the user into their specific groups (athlete or general population), questions will also be used to determine gender, age and how sensitive their skin is to UV enabling personalized messages to be developed. Software algorithms will work at the back-end of the app to process the weather data into three categories based on the World Health Organisation Guidelines 1) Extreme, Very High, High, 2) Moderate and 3) Low). The app will allow tailored messages (via app push notifications) with the aim to decrease risk of sunburn.

Telephone numbers will also be collected at enrollment so we can conduct a telephone evaluation interview up to 2 weeks following the study to determine satisfaction with the app, prediction tool and messages, and identify any barriers to use. The evaluation interview will take 20 minutes to complete. Participants will also be asked about their sun exposure practices and rates of sunburn during the one week of app use, as well as satisfaction with the app. Participants who complete all the study procedures may choose to enter a prize draw to win one of 5 x $100 gift vouchers. Participants will be asked if they would like to the prize draw entry (optional) after completing the evaluation interview.

Metric data will be collected via the app such as number of downloads, uninstalls, retention rate, daily active users, frequency of app sessions and app rating will also be collected and analysed
Intervention code [1] 301596 0
Prevention
Intervention code [2] 301597 0
Behaviour
Intervention code [3] 301598 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306393 0
satisfaction with use of device/technology/messages (Using questionnaire designed specifically for this study)
Timepoint [1] 306393 0
Evaluation Phone Interview (single assessment conducted up to 2 weeks post completion of intervention)
Secondary outcome [1] 348333 0
barriers to uptake of intervention
Timepoint [1] 348333 0
Evaluation Phone Interview (single assessment conducted up to 2 weeks post completion of intervention)
Secondary outcome [2] 349593 0
sun exposure practices (using the Sun Protection Habits index by Glanz et al), sunburn history (yes/no),
Timepoint [2] 349593 0
Evaluation Phone Interview (single assessment conducted up to 2 weeks post completion of intervention)
Secondary outcome [3] 349594 0
app metrics (number of downloads, uninstalls, retention rate, daily active users, frequency of app sessions and app rating)
Timepoint [3] 349594 0
Collected by the app developers via their database (single assessment at the completion of the intervention)

Eligibility
Key inclusion criteria
males and females 15+, athlete or spectator attending the Australian Transplant Games 2018 on the Gold Coast, Queensland, Understand sufficient English; cognitive ability for consent; own a private mobile phone with internet access to be able to use the SunVisor app.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergy to sunscreen

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Counts and percentages will be used to analyse the baseline and evaluation survey data. Metric data will be collected via the app such as number of downloads, uninstalls, retention rate, daily active users, frequency of app sessions and app rating will also be collected and analysed.

We plan to acquire 200 people to participate. It is expected that 240 will participate in the study with an approximate 20% attrition rate due to failing to meet eligibility criteria or participate in evaluation. The 20% attrition rate is based on our previous research study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2018
Actual
12/09/2018
Date of last participant enrolment
Anticipated
6/10/2018
Actual
3/10/2018
Date of last data collection
Anticipated
20/10/2018
Actual
3/11/2018
Sample size
Target
240
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 23061 0
4217 - Gold Coast

Funding & Sponsors
Funding source category [1] 299851 0
University
Name [1] 299851 0
Queensland University of Technology
Country [1] 299851 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Avenue, Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 299205 0
None
Name [1] 299205 0
Address [1] 299205 0
Country [1] 299205 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300727 0
Queensland University of Technology University Human Research Ethics Committee [EC00171]
Ethics committee address [1] 300727 0
Ethics committee country [1] 300727 0
Australia
Date submitted for ethics approval [1] 300727 0
27/06/2018
Approval date [1] 300727 0
09/07/2018
Ethics approval number [1] 300727 0
1800000182

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84618 0
Dr Elke Hacker
Address 84618 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 84618 0
Australia
Phone 84618 0
+61 7 3138 9674
Fax 84618 0
Email 84618 0
[email protected]
Contact person for public queries
Name 84619 0
Elke Hacker
Address 84619 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 84619 0
Australia
Phone 84619 0
+61 7 3138 9674
Fax 84619 0
Email 84619 0
[email protected]
Contact person for scientific queries
Name 84620 0
Elke Hacker
Address 84620 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 84620 0
Australia
Phone 84620 0
+61 7 3138 9674
Fax 84620 0
Email 84620 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported after deidentification.
When will data be available (start and end dates)?
Data are available beginning 3 months and ending 5 years following last data collection.
Available to whom?
Researchers conducting meta-analyses to be submitted to peer-review who provide a methodologically sound proposal.
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
Proposals should be directed to [email protected] To gain access, data requesters will need to agree to a data access agreement. Data are available for 5 years after the article publication.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.