Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001296527
Ethics application status
Approved
Date submitted
6/05/2015
Date registered
27/11/2015
Date last updated
10/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of personal ultraviolet radiation (UVR) devices and the SunSmart phone application on sun protection habits.
Scientific title
The effect of personal ultraviolet radiation (UVR) devices and the SunSmart phone application on sun protection habits in the adult population in Queensland.
Secondary ID [1] 286620 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
SknTec
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer 294937 0
Condition category
Condition code
Public Health 295194 295194 0 0
Health promotion/education
Cancer 297065 297065 0 0
Non melanoma skin cancer
Cancer 297117 297117 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: UVR Device Group
We will recruit male and female volunteers from the general community in Queensland. We wish to assess whether receiving daily UVR information or a personal UVR feedback device will increase the mean sun protection habits index score (compared to the control group) by half a standard deviation one week after the intervention, and whether this score will be sustained for 3 months after the intervention. This group will be asked to wear the UVR dosimeter feedback device pinned to clothing during daylight hours for 1 month (manufactured by Healthtronics SunSafe). This device provides information to the participant on current UVR dose and whether they fall within a safe range. A daily diary will be used to monitor adherence.

Arm 2: SunSmart App Group
We will recruit male and female volunteers from the general community in Queensland. We wish to assess whether receiving daily UVR information or a personal UVR feedback device will increase the mean sun protection habits index score (compared to the control group) by half a standard deviation one week after the intervention, and whether this score will be sustained for 3 months after the intervention. This group will be asked to use the SunSmart phone application on their phone for 1 month with daily UV notification alerts (programmed by Cancer Council Victoria).The SunSmart notifies participants when sun protection is required . A daily diary will be used to monitor adherence.
Intervention code [1] 291756 0
Prevention
Intervention code [2] 293306 0
Behaviour
Intervention code [3] 293307 0
Lifestyle
Comparator / control treatment
Arm 3: No Intervention Control Group
We will recruit male and female volunteers from the general community in Queensland. We wish to assess whether there is a difference over time between the control group and intervention groups on sun protection habits, sun exposure behaviours, sunburn, and physical activity levels. Participants in this group will not receive any devices or technology and will be asked to go about their normal everyday activities.
Control group
Active

Outcomes
Primary outcome [1] 294947 0
Sun Protection Habits Score (Using Sun Protection Habbits Index).
Timepoint [1] 294947 0
At baseline, 1-week, and 3-months after intervention commencement.
Secondary outcome [1] 314448 0
Sunburn Incidence (Using questionnaire designed specifically for this study)
Timepoint [1] 314448 0
At baseline, 1-week, and 3-months after intervention commencement.
Secondary outcome [2] 319092 0
physical activity levels (Using questionnaire designed specifically for this study)
Timepoint [2] 319092 0
At baseline, 1-week and 3 months after intervention commencement.
Secondary outcome [3] 319093 0
satisfaction with use of device/technology (Using questionnaire designed specifically for this study)
Timepoint [3] 319093 0
3 month after intervention commencement

Eligibility
Key inclusion criteria
Understand sufficient English; cognitive ability for consent; own a private mobile phone; Fitzpatrick skin type 1-3: no previous melanoma; individuals who do not use the SunSmart application on a regular basis. Drawing from our experience and previous studies, we estimate 85% of interested volunteers will fulfil these criteria. We will assess pigmentation and skin cancer history during screening using a questionnaire developed from our previous studies.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
This trial has no exclusion criteria related to age, socio economic status, gender, or ethnicity. This means that individuals with characteristics associated with poorer outcomes (e.g., younger age, lower socio-economic status, and those living in rural areas) will be eligible to participate. Randomisation of participants, and presenting or providing material to a standard English level (ILR Level 3) will help to minimise any equity issues that may arise during the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants (males and females 18-35 years) will be recruited from the local community on a volunteer basis via media campaigns and flyers. While it is possible that this recruitment strategy will not provide a fully representative sample, other recruitment methods have their own biases and are less suitable for young populations (e.g., using the white pages or the electoral roll). The RCT design of our study will ascertain internal validity. While the intervention would be suitable to people all over Australia, we will first test it in Queensland where the UV Index is high (>3) throughout the year, requiring sun protection almost all year round. To alleviate the impact of seasonal variation the intervention will run over the summer months with enrolment of participants during spring. Central randomisation by computer will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once the baseline visit is completed, randomisation will be conducted by a computerised random-number generator, stratified by gender (male/female), Fitzpatrick skin type (1-3), and age group (18-35 years), in permuted blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Continuous data will be summarised by presenting the descriptive statistics (e.g., mean, standard deviation). We will use suitable tests to assess differences between groups (t tests for simple tests; ANOVA and regression for multivariate assessments). Categorical data will be summarised by presenting the number and percentage in each category, and the chi square statistic test will be calculated for association. All statistical tests of significance will be performed at the 5% level of significance and will be 2-sided unless otherwise stated.
The intention-to-treat principle will be used for the analysis of the primary hypotheses. One of the main strengths of RCT design is that the effect of potential confounders should be equalised between groups at baseline. The intervention groups will be compared to the control group with respect to baseline characteristics and outcome measures using analysis of variance, and other generalised linear models as appropriate (depending on the measurement scale of the outcome). A dichotomous variable representing the intervention arm (UVR dosimeter or UVR app versus control) will be included to enable assessment of the independent effect of the respective intervention group, compared to the control group. Linear and logistic regression models with the intervention versus control arm as the between-subjects factor will be used to analyse the outcome measures between the study arms at three-months follow-up, with Poisson models used to count data. These analyses will allow us to identify the independent effect of the intervention on participants’ behaviour in relation to sun protection habits and sunburn. For the longitudinal analysis we will adopt a generalised estimating equation approach to model the repeated binary outcomes. We will also examine whether there is a dose-response relationship between degree of device use and outcomes. Satisfaction with the use and recall of the dosimeter alarm or app messages, and attitudes and intentions will be analysed using descriptive statistics.
Sample size estimation: Using the data gathered from our earlier research project, which assessed the impact of personalised mobile phone messages on improving skin protection behaviours in young adults, we observed a standard deviation of 0.5 among a similar Queensland study sample 18 to 42 year olds (Janda et al. 2013). Our sample size calculations are based on a similar common standard deviation, and will allow us to detect a difference in the mean score of 0.3 between the intervention and control group (e.g., an increase in the mean score from 2.3 to 2.6 at follow-up in the intervention group while the control group mean score remains constant at 2.3). Corresponding with an effect size of 0.4, given a common standard deviation of 0.5 between three groups, where two of the groups are compared to one control group (based on the Dunnett multiple comparison test). Our sample of 201 participants (67 participants per intervention group) will allow for attrition rates of up to 10%. We have previously found attrition rates less than 10% in this population (Hacker et al. 2013). As this is an emerging new field of research, the magnitude of anticipated effects may be larger. Evidence from feedback devices in physical activity research suggests that it may induce an improvement in intervention group behaviours compared to the control group of a moderate effect size (King et al. 2013, Stephens et al. 2013).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/07/2015
Date of last participant enrolment
Anticipated
31/12/2015
Actual
9/11/2015
Date of last data collection
Anticipated
Actual
5/04/2016
Sample size
Target
201
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 9619 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 291189 0
Charities/Societies/Foundations
Name [1] 291189 0
Cancer Council Queensland
Country [1] 291189 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Ave,
Kelvin Grove, Brisbane, Queensland, 4059
Country
Australia
Secondary sponsor category [1] 289869 0
None
Name [1] 289869 0
Address [1] 289869 0
Country [1] 289869 0
Other collaborator category [1] 278460 0
Individual
Name [1] 278460 0
Professor John Lowe
Address [1] 278460 0
University of the Sunshine Coast
90 Sippy Downs Drive, Sippy Downs QLD 4556
Country [1] 278460 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292761 0
Queensland University of Tecnology Human Ethics Committee
Ethics committee address [1] 292761 0
Ethics committee country [1] 292761 0
Australia
Date submitted for ethics approval [1] 292761 0
Approval date [1] 292761 0
10/09/2014
Ethics approval number [1] 292761 0
1400000302

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

Contacts
Principal investigator
Name 56890 0
Dr Elke Hacker
Address 56890 0
Queensland University of Technology
School of Public Health and Social Work
Victoria Park Road
Kelvin Grove QLD 4059
Country 56890 0
Australia
Phone 56890 0
+61 7 3138 9674
Fax 56890 0
Email 56890 0
[email protected]
Contact person for public queries
Name 56891 0
Elke Hacker
Address 56891 0
Queensland University of Technology
School of Public Health and Social Work
Victoria Park Road
Kelvin Grove QLD 4059
Country 56891 0
Australia
Phone 56891 0
+61 7 3138 9674
Fax 56891 0
Email 56891 0
[email protected]
Contact person for scientific queries
Name 56892 0
Elke Hacker
Address 56892 0
Queensland University of Technology
School of Public Health and Social Work
Victoria Park Road
Kelvin Grove QLD 4059
Country 56892 0
Australia
Phone 56892 0
+61 7 3138 9674
Fax 56892 0
Email 56892 0
[email protected]

No information has been provided regarding IPD availability


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
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