Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001299291
Ethics application status
Approved
Date submitted
23/07/2018
Date registered
2/08/2018
Date last updated
28/06/2021
Date data sharing statement initially provided
12/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving sun protection behaviour in young Australian adults using a digital behavioral intervention
Scientific title
Improving sun protection behaviour in young Australian adults using a digital behavioral intervention: a cross-over design study
Secondary ID [1] 295431 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin cancer 308689 0
Sunburn 308922 0
Sun exposure 308923 0
Condition category
Condition code
Cancer 307618 307618 0 0
Malignant melanoma
Cancer 307619 307619 0 0
Non melanoma skin cancer
Public Health 307826 307826 0 0
Health promotion/education
Injuries and Accidents 307870 307870 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to assess whether personalisation and interactivity of theory-based sun protection text messages improve young adults’ self-reported skin cancer prevention behaviours and whether it is better to send messages with higher frequency early or later during the behavioral intervention.
To test these aims, we will use a Latin-Square cross-over design in which all participants move through all intervention conditions, but in random order.

There are 4 intervention groups:
A - Personalised sun protection messages 3 times a week for 4 weeks.
B - Interactive sun protection messages 3 times a week for 4 weeks.
C - Personalised and interactive early intensity sun protection messages (daily for the first 2 weeks, then 3 times a week for 2 weeks).
D - Personalised and interactive late intensity messages (3 times a week for the first 2 weeks then increase to daily for 2 weeks).

Each group (A-D) lasts for 4 consecutive weeks. There is a one week break before being assigned to the next group, and a short online (5 minutes) survey to be completed during the one week break.

Messages will be personalised according to demographic and phenotypic characteristics, health behaviour and personal skin cancer prevention-related goals that are collected in the online baseline survey (20-30 minutes). Short messages as well as graph, diagrams, pictorial content apps and videos will be provided by sending a link in the SMS, which will place freely available content. Interactive message design will encourage users to reach a goal or win an online medal such as use of protective clothing, search for a mole, share messages with friends/family.

All participants complete an online survey at 6 months post-intervention (20-30 minutes). The 6 month survey will assess sun protection behaviours, sun protection attitudes, sunburn history and suntan history.

Participants are recruited via the population-based Australian Medicare system. Medicare facilitates research by sending letters to Medicare members, maintaining their privacy, asking them to respond directly to the research team if interested to participate. Only people who receive an invitation letter from Medicare may participate.

To assess adherence to the intervention, responses to the interactive text messages (Group B-D) will be analysed. For Group A, we will ask participants to self-report whether they read the text messages.
Intervention code [1] 301744 0
Prevention
Intervention code [2] 301862 0
Behaviour
Comparator / control treatment
This study is a Latin-Square crossover design with 4 interventions compared.
Control group
Active

Outcomes
Primary outcome [1] 306755 0
Sun protection habits index developed by Glanz and colleagues
Timepoint [1] 306755 0
1-month, 2-month, 3-month, 4-month and 6-month [primary timepoint]
Primary outcome [2] 306756 0
Sunburn (yes/no)
Timepoint [2] 306756 0
1-month, 2-month, 3-month, 4-month and 6-month [primary timepoint]
Secondary outcome [1] 349493 0
After intervention completion measures will be collected to allow assessment of whether behaviour change was enacted through the proposed components of the COM-B model (e.g. self-efficacy, social support, role modelling).
Timepoint [1] 349493 0
6-month follow-up survey
Secondary outcome [2] 349709 0
Technology acceptance (questionnaire from our previous study (not validated), adapted specifically for this study)
Timepoint [2] 349709 0
6-month follow-up survey
Secondary outcome [3] 350153 0
Satisfaction with the text messaging intervention (questionnaire from our previous study (not validated), adapted specifically for this study)
Timepoint [3] 350153 0
6-month follow-up survey
Secondary outcome [4] 350154 0
Importance of allocated health behaviours (questionnaire from our previous study (not validated), adapted specifically for this study)
Timepoint [4] 350154 0
6-month follow-up survey
Secondary outcome [5] 350252 0
Level of engagement (questionnaire from our previous study (not validated), adapted specifically for this study)
Timepoint [5] 350252 0
6-month follow-up survey

Eligibility
Key inclusion criteria
- Men and women 18-40 years;
- Member of Australian Medicare system;
- Resides in Queensland, Australia;
- Understand sufficient English;
- Cognitive ability to consent;
- Access to a smart phone with camera;
- Presence of at least two skin cancer risk factors (light hair color, skin that rarely or never tans, skin that burns easily, many moles, family/personal history of skin cancer).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics of all baseline, feasibility and process measures, sun protection, sunburn, and their frequency and extent will be computed. Recruitment and retention rates in each group will be compared using chi-square tests, and rates will be reported as percentage and 95% confidence intervals.
Analyses of the 4x4 Latin Square design: rows are the groups into which participants are assigned at random (sequence of treatments A-D), and columns are time points. The Latin Square design is more efficient than simple randomisation or a full factorial design, and will allow us to investigate the treatment order effect and account for its presence. The analysis of the data will use linear models and linear mixed models (linear for continuous outcomes and generalized with a binomial link for binary outcomes) as discussed by Senn 2002. Fixed effects of time and baseline measures, and random effects of subject and group will fitted. Mixed models account for the correlated data due to repeated measures on participants and have very good properties with respect to missing data. If the missing outcome data rate is higher than 10% we will perform sensitivity analyses using multiple imputations.
The design also allows us to estimate period effects, or interaction between period and treatment (for example it may be more beneficial to receive frequent sun protection messages first, rather than during maintenance). This means that using the Latin Square design we can answer a number of highly valuable and novel research questions, or great importance to skin cancer prevention leading to direct information for sun protection policy and practice.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2018
Actual
7/12/2018
Date of last participant enrolment
Anticipated
14/01/2019
Actual
1/02/2019
Date of last data collection
Anticipated
31/12/2019
Actual
31/01/2020
Sample size
Target
380
Accrual to date
Final
415
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 23457 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 300017 0
Charities/Societies/Foundations
Name [1] 300017 0
Harry Lloyd Charitable Trust
Country [1] 300017 0
United States of America
Primary sponsor type
University
Name
Centre for Health Services Research, Faculty of Medicine, The University of Queensland
Address
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 299404 0
University
Name [1] 299404 0
Dermatology Research Centre, University of Queensland
Address [1] 299404 0
37 Kent Street
Woolloongabba QLD 4102
Country [1] 299404 0
Australia
Other collaborator category [1] 280238 0
Individual
Name [1] 280238 0
Prof Monika Janda
Address [1] 280238 0
Centre of Health Services Research
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country [1] 280238 0
Australia
Other collaborator category [2] 280239 0
Individual
Name [2] 280239 0
Prof H Peter Soyer
Address [2] 280239 0
Translational Research Centre (TRI)
Dermatology Research Centre
37 Kent Street
Woolloongabba QLD 4102
Country [2] 280239 0
Australia
Other collaborator category [3] 280240 0
Individual
Name [3] 280240 0
A/Prof Lois Loescher
Address [3] 280240 0
The University of Arizona Colleges of Nursing & Public Health
PO Box 210203
Tuscon Arizona 85721-0203
Country [3] 280240 0
United States of America
Other collaborator category [4] 280241 0
Individual
Name [4] 280241 0
Prof Peter Baade
Address [4] 280241 0
Cancer Council Queensland
553 Gregory Terrace
Fortitude Valley QLD 4006
Country [4] 280241 0
Australia
Other collaborator category [5] 280242 0
Individual
Name [5] 280242 0
A/Prof Craig Sinclair
Address [5] 280242 0
Cancer Council Victoria
615 St Kilda Road
Melbourne Victoria, 3004
Country [5] 280242 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300870 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 300870 0
Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia
Ethics committee country [1] 300870 0
Australia
Date submitted for ethics approval [1] 300870 0
04/06/2018
Approval date [1] 300870 0
31/07/2018
Ethics approval number [1] 300870 0

Summary
Brief summary
This study aims to compare a number of sun protection messages to improve skin cancer prevention behaviours

Who is it for?
People who are aged 18-40 years, have a smartphone with a camera, are on the Australian Medicare system, residing in Queensland, and have at least 2 skin cancer risk factors (light hair color, skin that rarely or never tans, skin that burns easily, many moles, family/personal history of skin cancer) are eligible to participate in this study.
Sample will be recruited via the population-based Australian Medicare system.

Study details
Participants will be randomised to one of 4 groups. These 4 groups will cycle through the 4 different interventions in a random order. All participants will undertake the 4 interventions, only the order will vary. The interventions are as follows:
A - Personalised sun protection messages
B - Interactive sun protection messages
C - Personalised and interactive early intensity sun protection messages
D - Personalised and interactive late intensity messages

At the beginning of the study as well as 6 months post-commencement, participants will complete an online survey (20-30minutes), and between the different interventions, participants will complete an online short (5 minutes) online survey

This study will create a highly valuable database of evidence-based intervention messages that may help prevent sunburns and reduce the risk of developing melanoma and other skin cancers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85102 0
Prof Monika Janda
Address 85102 0
Centre for Health Services Research
Faculty of Medicine, The University of Queensland
Building 33, Princess Alexandra Hospital
Woolloongabba, QLD, 4102
Country 85102 0
Australia
Phone 85102 0
+61 7 3176 4569
Fax 85102 0
Email 85102 0
[email protected]
Contact person for public queries
Name 85103 0
Monika Janda
Address 85103 0
Centre for Health Services Research
Faculty of Medicine, The University of Queensland
Building 33, Princess Alexandra Hospital
Woolloongabba, QLD, 4102
Country 85103 0
Australia
Phone 85103 0
+61 7 3176 4569
Fax 85103 0
Email 85103 0
[email protected]
Contact person for scientific queries
Name 85104 0
Monika Janda
Address 85104 0
Centre for Health Services Research
Faculty of Medicine, The University of Queensland
Level 2, Building 33, Princess Alexandra Hospital
Woolloongabba, QLD, 4102
Country 85104 0
Australia
Phone 85104 0
+61 7 3176 4569
Fax 85104 0
Email 85104 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
108Study protocol  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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