Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001581257
Ethics application status
Approved
Date submitted
18/09/2018
Date registered
24/09/2018
Date last updated
26/06/2019
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sun safe clothing and accessories: do rashies and UV stickers decrease the risk of sunburn in healthy adults?
Scientific title
Sun safe clothing and accessories: do rashies and UV stickers decrease the risk of sunburn in healthy adults?
Secondary ID [1] 296012 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sunburn 309546 0
sun exposure 309547 0
Condition category
Condition code
Public Health 308365 308365 0 0
Health promotion/education
Cancer 308366 308366 0 0
Malignant melanoma
Cancer 308367 308367 0 0
Non melanoma skin cancer
Skin 308534 308534 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study population:
Participants are individuals 18+ years of age who buy an Ugly Xmas Rashie/Cycling Jersey online (they are only available for purchase online and not in store) will be invited to participate in this research project. Participants are invited to opt in to the study at online checkout (tick box option). The Ugly Xmas Rashie and Cycling Jersey ships internationally, and all customers (both in Australia and overseas) who purchase either clothing item will be invited to participate.

Consent and enrolment process:
To enrol in the project, interested participants check an extra box at the checkout. Individuals who check the box, will be email and invitation to the study including a survey link taking take them to an online PICF, where they will be asked to confirm consent online (tick box) and then proceed to complete a baseline survey (10 minutes). Participants will be asked to enrol in the study within 1 week of purchasing the clothing.

Study design: longitudinal, cross-sectional survey, observational, analytical, non experimental

Baseline Survey: The baseline survey will collect data on demographics (gender, age, skin cancer history), sunburn incidence, regular sun protection habits, sunscreen use and clothing purchasing decisions. Participants are asked to provide a name and email in order to send the evaluation survey.

Methods: The participants use the Ugly Xmas Rashie/Cycling Jersey as they see fit, and asked to go about their normal daily activities. Participants will additionally be provided with UV indicating stickers (Suncayr) www.suncayr.ca. enclosed with the postal delivery of the rashie/Cycling Jersey. The commercially available UV indicating stickers are designed to provide personalized and rapid feedback to the users about how much sunscreen is protecting their skin. Sunscreen is applied over the sticker and it will change colour alerting the user their sunscreen has worn off, indicating reapplication is required. Participants will be asked to use the UV stickers as they see fit (as much or little as they like). The observation period is three months duration over the Australian spring/summer (approximately October 2018 - December 2018).

Evaluation Survey: After the observation period (3 months of rashie/Cycling Jersey and sticker use) participants will be emailed a link to complete an online evaluation survey (20 minutes). The survey will collect information on sun protection habits, sunburn incidence, sunscreen use and satisfaction with the intervention products (both the rashie/Cycling Jersey and the stickers).
Intervention code [1] 312448 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307346 0
satisfaction with use of clothing (Using questionnaire designed specifically for this study)
Timepoint [1] 307346 0
Online evaluation survey (single assessment conducted 3-months post completion of intervention)
Primary outcome [2] 307348 0
sun exposure practices (using the Sun Protection Habits index by Glanz et al)
Timepoint [2] 307348 0
Online evaluation survey (single assessment conducted 3-months post completion of intervention)
Secondary outcome [1] 351556 0
satisfaction with use of UV indicating stickers (Using questionnaire designed specifically for this study)
Timepoint [1] 351556 0
Online evaluation survey (single assessment conducted 3-months post completion of intervention)
Secondary outcome [2] 352110 0
sunburn incidence (yes/no)
Timepoint [2] 352110 0
Online evaluation survey (single assessment conducted 3-months post completion of intervention)

Eligibility
Key inclusion criteria
males and females 18+, purchasing an Ugly Xmas Rashie or Ugly Xmas Cycling Jersey from https://uglyxmasrashie.com.au/ Understand sufficient English; cognitive ability for consent;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
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
Statistical methods / analysis
Counts and percentages will be used to analyse the baseline and evaluation survey data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2018
Actual
19/10/2018
Date of last participant enrolment
Anticipated
1/12/2018
Actual
10/02/2019
Date of last data collection
Anticipated
31/03/2019
Actual
10/05/2019
Sample size
Target
500
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300607 0
University
Name [1] 300607 0
Queensland University of Technology
Country [1] 300607 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] 300112 0
None
Name [1] 300112 0
Address [1] 300112 0
Country [1] 300112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301393 0
Queensland University of Technology University Human Research Ethics Committee [EC00171]
Ethics committee address [1] 301393 0
Ethics committee country [1] 301393 0
Australia
Date submitted for ethics approval [1] 301393 0
23/08/2018
Approval date [1] 301393 0
11/09/2018
Ethics approval number [1] 301393 0
1800000851

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

Contacts
Principal investigator
Name 86854 0
Dr Elke Hacker
Address 86854 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 86854 0
Australia
Phone 86854 0
+61 7 3138 9674
Fax 86854 0
Email 86854 0
elke.hacker@qut.edu.au
Contact person for public queries
Name 86855 0
Elke Hacker
Address 86855 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 86855 0
Australia
Phone 86855 0
+61 7 3138 9674
Fax 86855 0
Email 86855 0
elke.hacker@qut.edu.au
Contact person for scientific queries
Name 86856 0
Elke Hacker
Address 86856 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 86856 0
Australia
Phone 86856 0
+61 7 3138 9674
Fax 86856 0
Email 86856 0
elke.hacker@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.