Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001035617
Ethics application status
Approved
Date submitted
6/09/2023
Date registered
22/09/2023
Date last updated
23/02/2024
Date data sharing statement initially provided
22/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Sun Wise Study: Examining the impact of a personalised skin cancer prevention strategy among people with a history of skin cancer
Scientific title
The Sun Wise Study: A randomised controlled trial of the effect of a personalised skin cancer prevention strategy (personal UV exposure alerts and daily SMS sun protection reminders) on UV exposure in people with a history of skin cancer
Secondary ID [1] 310556 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin cancer 331389 0
Condition category
Condition code
Cancer 328136 328136 0 0
Non melanoma skin cancer
Cancer 328137 328137 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participation in the study for intervention participants will involve:
1. The completion of an online survey at baseline. This survey will seek information on demographics, skin cancer risk factors, sun habits, sun protection behaviours and psychological outcomes. This survey should take around 20 minutes to complete.
2. 7-day wear of a UV dosimeter at baseline and again during the intervention period. In the intervention period, the control and intervention participants will be matched by randomisation criteria to ensure UV dosimeter wear occurs at a similar time.
3. Completing a 7-day activity diary at baseline and again during the intervention period. This survey should take around 5 minutes to complete.
4. Receiving two educational booklets: Melanoma Prevention and Early Detection Guide (Melanoma Institute Australia) and Understanding Skin Cancer: a guide for people with cancer, their families and friends (Cancer Council).
5. The Sun Wise Strategy, comprising of 7-day wear of the Sun Watch, which provides personal UV exposure alerts, and daily SMS sun protection reminders. The Sun Watch is a UV dosimeter (electronic measure of real-time sun exposure, measured in standard erythemal doses, SEDs) with an integrated LED light. The LED light flashes automatically when there is a change in the UV index, for example when the wearer moves from indoors to outdoors. Adherence to the intervention will be assessed when the watches are returned to the study team. As the UV data are downloaded, a member of the research team will check the data and identify any potential issues, such as non-compliance (i.e. Sun Watches being left out in the sun or indoors unworn) or any malfunctions.
Intervention code [1] 326954 0
Behaviour
Intervention code [2] 326955 0
Prevention
Comparator / control treatment
Participants randomised to the control arm will only be involved in parts 1-4 as described above. This includes the completion of an online survey at baseline, 7-day wear of a UV dosimeter at baseline and again during the intervention period, completing a 7-day activity diary at baseline and again during the intervention period, and receiving the same two educational booklets provided to the intervention arm participants.
Control group
Active

Outcomes
Primary outcome [1] 336013 0
The primary outcome is total daily Standard Erythemal Doses (SEDs), an objective measure of ultraviolet radiation (UVR) exposure, measured at baseline and the 1 month follow-up timepoint. SEDs will be measured using time-stamped electronic dosimeter badges, mounted in light-weight custom-made wristbands attached to the left wrist (similar to wearing a watch) during daylight hours. UV dosimeters will be worn by all participants for 7 days at baseline and again 1 month after baseline. The data collected on weekdays will be averaged over 5 days and the data collected on weekends will be averaged over 2 days to enable an average weekly and average daily dose to be calculated.
Timepoint [1] 336013 0
Over 7-day periods at baseline and again at follow-up at approximately 1 month after baseline
Secondary outcome [1] 426465 0
Daily Standard Erythemal Doses (SEDs) during peak-time periods of day. SEDs will be measured using time-stamped electronic dosimeter badges, mounted in light-weight custom-made wristbands attached to the left wrist (similar to wearing a watch) during daylight hours. UV dosimeters will be worn by all participants for 7 days at baseline and 1 month after baseline. The data collected on weekdays will be averaged over 5 days and the data collected on weekends will be averaged over 2 days to enable an average weekly and average daily dose to be calculated.
Timepoint [1] 426465 0
Over 7-day periods at baseline and again at follow-up at approximately 1 month after baseline
Secondary outcome [2] 426466 0
Sunburn frequency, measured using a questionnaire item in the baseline and both activity diaries: 'In the past week, how many times did you have a red OR painful sunburn that lasted a day or more?'
Timepoint [2] 426466 0
Over 7-day periods at baseline and again at follow-up at approximately 1 month after baseline
Secondary outcome [3] 426467 0
Sun protection behaviours, measured by the frequency of: sunscreen use, wearing a shirt with sleeves, wearing a hat, seeking shade, wearing sunglasses, limiting peak-time sun exposure. This will be measured at the end of each of the 7 days during the baseline and follow-up timepoints, using questionnaire items in the activity diary, It will be calculated as the mean of six protective behaviours on a 4-point Likert scale (1=never or rarely, 4=always): 'When outside, how often did you... wear sunscreen? wear a shirt with sleeves that cover your shoulders? wear a hat? stay in the shade or under an umbrella? wear sunglasses? limit your time in the sun during midday hours?' This will be assessed as a composite outcome.


Timepoint [3] 426467 0
Over 7-day periods at baseline and again at follow-up at approximately 1 month after baseline
Secondary outcome [4] 426468 0
Intentional tanning frequency, measured using a questionnaire item ‘How often do you spend time in the sun in order to get a tan?’ measured on a 5-point Likert scale (1=never, 5=always).
Timepoint [4] 426468 0
Over 7-day periods at baseline and again at follow-up at approximately 1 month after baseline
Secondary outcome [5] 426469 0
Health related physical activity will be a self-reported measure in the activity diaries. It is measured using seven items from the International Physical Activity Questionnaire-Short Form (IPAQ-SF), which asks about three specific types of activities: walking, moderate-intensity activities and vigorous intensity activities; frequency (measured in days per week) and duration (time per day) are collected separately for each specific type of activity.
Timepoint [5] 426469 0
Over 7-day periods at baseline and again at follow-up at approximately 1 month after baseline
Secondary outcome [6] 426470 0
Skin cancer-related worry, measured in the baseline questionnaire and second activity diary, using three items related to future skin cancer, and the impact of skin cancer worry on mood and daily activities on a 5- point Likert scale (1=not at all, 5=almost all the time).
Timepoint [6] 426470 0
Baseline and approximately 1 month after baseline
Secondary outcome [7] 426471 0
Fear of cancer recurrence, measured in the baseline questionnaire and second activity diary, using nine items from the Fear of Cancer Recurrence Inventory-Short Form Screening, which assesses the presence, frequency, intensity, and duration of thoughts associated with fear of cancer recurrence.
Timepoint [7] 426471 0
Baseline and approximately 1 month after baseline
Secondary outcome [8] 426472 0
Psychological distress and well-being, measured in the baseline questionnaire and second activity diary, using the 5-item version of the Mental Health Inventory (MHI-5) designed for primary care settings. This will be assessed as a composite outcome.
Timepoint [8] 426472 0
Baseline and approximately 1 month after baseline
Secondary outcome [9] 426473 0
Costs related to sun protection (or sun protection purchases), measured in the second activity diary. Participants are asked to indicate the purchase of sun protection items (hat, sunscreen, shade cover, UV protective clothes or swimwear) in the past month.
Timepoint [9] 426473 0
approximately 1 month after baseline only
Secondary outcome [10] 426476 0
Participant satisfaction with the two general educational booklets will be measured in the second activity diary, using questionnaire items developed for this study (composite outcome)
Timepoint [10] 426476 0
approximately 1 month after baseline only
Secondary outcome [11] 426477 0
Participant satisfaction with the personalised SMS sun protection reminders will be measured (for intervention participants only) in the second activity diary, using questionnaire items developed for this study.
Timepoint [11] 426477 0
approximately 1 month after baseline only (intervention participants only)
Secondary outcome [12] 426478 0
Participant usability of the Sun Watch and receiving personal UV exposure alerts via the LED light will be measured (for intervention participants only) in the second activity diary, using ten questionnaire items from the System Usability Scale (Brooke et al. 1996).
Timepoint [12] 426478 0
approximately 1 month after baseline only (intervention participants only)
Secondary outcome [13] 426479 0
Participant engagement with the personalised SMS sun protection reminders will be measured (for intervention participants only) in the second activity diary, developed from four Y/N questionnaire items used in a randomised, attention control trial on mobile phone text messaging to improve skin cancer prevention and early detection (Youl et al. 2014). 'Thinking about the personalised SMS sun protection reminders, did you: Read and keep the messages? Read and delete the messages? Delete before reading the messages? Forward messages to friends or family?'
Timepoint [13] 426479 0
approximately 1 month after baseline only (intervention participants only)
Secondary outcome [14] 426829 0
Hat wear: Please select the option which is most similar to your usual headwear when in the sun in the past month. Response options are: no headwear, beanie, cap, legionnaires, bucket hat, wide brimmed, veil/burkha.
Timepoint [14] 426829 0
Over 7-day periods at baseline and again at follow-up at approximately 1 month after baseline
Secondary outcome [15] 426830 0
Daily Standard Erythemal Doses (SEDs) during morning periods of day. SEDs will be measured using time-stamped electronic dosimeter badges, mounted in light-weight custom-made wristbands attached to the left wrist (similar to wearing a watch) during daylight hours. UV dosimeters will be worn by all participants for 7 days at baseline and 1 month after baseline. The data collected on weekdays will be averaged over 5 days and the data collected on weekends will be averaged over 2 days to enable an average weekly and average daily dose to be calculated.
Timepoint [15] 426830 0
Over 7-day periods at baseline and again at follow-up at approximately 1 month after baseline
Secondary outcome [16] 426831 0
Daily Standard Erythemal Doses (SEDs) during afternoon periods of day. SEDs will be measured using time-stamped electronic dosimeter badges, mounted in light-weight custom-made wristbands attached to the left wrist (similar to wearing a watch) during daylight hours. UV dosimeters will be worn by all participants for 7 days at baseline and 1 month after baseline. The data collected on weekdays will be averaged over 5 days and the data collected on weekends will be averaged over 2 days to enable an average weekly and average daily dose to be calculated.
Timepoint [16] 426831 0
Over 7-day periods at baseline and again at follow-up at approximately 1 month after baseline
Secondary outcome [17] 426832 0
Participant satisfaction with the Sun Watch will be measured (for intervention participants only) in the second activity diary, using questionnaire items developed for this study.
Timepoint [17] 426832 0
approximately 1 month after baseline only (intervention participants only)

Eligibility
Key inclusion criteria
Patients aged 18+ years, who have previously been diagnosed with skin cancer (including melanoma, basal cell carcinoma, squamous cell carcinoma), are able to read and write English and competent to give informed consent, are contactable and available over the next 2 months for follow-up, are willing and able to wear UV watches for two seven-day periods and have as a private mobile phone to receive SMS sun protection reminders.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under age 18 years, have never had a skin cancer, unable to read and write English, will not be contactable and available over the next 2 months for follow-up, unwilling or unable to wear up to two UV watches for two seven-day periods, or does not have a private mobile phone to receive SMS sun protection reminders.

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)
Randomisation to the intervention or control arm (allocation ratio 1:1) will be provided through the randomisation tool in REDCap (Research Electronic Data Capture). Therefore, staff involved in running the study will not have any influence over the randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After participants complete all baseline measurements, they will be randomised by permuted blocks stratified by gender, age (18-49, 50+) and study site. Randomisation to the intervention or control arm (allocation ratio 1:1) will be provided through the randomisation tool in REDCap (Research Electronic Data Capture). Therefore, staff involved in running the study will not have any influence over the randomisation process.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
Sample size calculations are based on detecting 20% difference in total daily SEDs between groups, calculated using a t-test with a geometric mean ratio (geometric mean SEDs in intervention group/geometric mean SEDs in control group) of 0.8, coefficient of variation 0.9, 80% power and a of 0.05, and assuming 15% loss to follow-up. Allowing up to 15% with incomplete follow-up at 1 month, we will need to recruit 446 people (223 in each of intervention and control arms).

Analysis plan:
The primary analysis will be an intention-to-treat comparison of intervention and control arms for mean differences in UVR exposure measured as log-transformed daily SEDs at the follow-up timepoint. UV watch values will be log-transformed because of their right-skew distribution, and log-transformed values will be interpreted as a percentage change in the geometric mean of SEDs/day. Generalized linear mixed models (GLMMs) with random intercepts will be fitted to outcome measures collected over the study to assess the overall intervention effect and the effect at the follow-up time point adjusted for baseline scores. For continuous outcomes, we will estimate the mean difference and 95% confidence intervals between intervention and control groups overall and at the follow-up time point. For binomial outcome variables, we will estimate relative risks and 95% CI overall and at pre-specified follow-up time points. The GLMM approach allows us to account for correlation due to repeated measures on each individual and different types of outcome variables (continuous, binary). All tests will be two sided with a nominal value of 0.05. The effects of potential mediators in facilitating behaviour change will be evaluated, using methods such as autoregressive mediation path models and the change-in-estimate.

The following subgroup analyses will also be performed because the effect of the intervention on behaviour change or psycho-social outcomes may be influenced by these factors:
• Gender
• Age: 18–50 vs. 50+
• Health literacy: good vs. poor
• Fear of Cancer Recurrence: high v low
• Skin cancer related worry
• Traditional (phenotypic) risk factors for skin cancer

We will use a chi-square test to see if the attrition rate differs by arm. If more than 15% of participants drop out we will use logistic regression to compare baseline characteristics of participants who completed the intervention versus those who did not. Each variable will be examined for the presence of missing data and if >10% is observed on key variables, sensitivity analysis will be performed using complete case analysis or multiple imputation methods.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
31/05/2025
Actual
Date of last data collection
Anticipated
26/07/2025
Actual
Sample size
Target
446
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314758 0
Government body
Name [1] 314758 0
National Health and Medical Research Council
Country [1] 314758 0
Australia
Funding source category [2] 314759 0
Other Collaborative groups
Name [2] 314759 0
Sydney Cancer Partners
Country [2] 314759 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 316743 0
None
Name [1] 316743 0
Address [1] 316743 0
Country [1] 316743 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313766 0
Sydney Local Health District, Human Research Ethics Committee (RPAH Zone)
Ethics committee address [1] 313766 0
Ethics committee country [1] 313766 0
Australia
Date submitted for ethics approval [1] 313766 0
28/08/2023
Approval date [1] 313766 0
26/09/2023
Ethics approval number [1] 313766 0
Protocol no. X23-0310 & 2023/ETH01926

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

Contacts
Principal investigator
Name 129298 0
Dr Amelia Smit
Address 129298 0
Level 1, A27 Edward Ford Building, The University of Sydney NSW 2006
Country 129298 0
Australia
Phone 129298 0
+61 2 8627 1530
Fax 129298 0
Email 129298 0
[email protected]
Contact person for public queries
Name 129299 0
Amelia Smit
Address 129299 0
Level 1, A27 Edward Ford Building, The University of Sydney NSW 2006
Country 129299 0
Australia
Phone 129299 0
+61 2 8627 1530
Fax 129299 0
Email 129299 0
[email protected]
Contact person for scientific queries
Name 129300 0
Amelia Smit
Address 129300 0
Level 1, A27 Edward Ford Building, The University of Sydney NSW 2006
Country 129300 0
Australia
Phone 129300 0
+61 2 8627 1530
Fax 129300 0
Email 129300 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
IPD will not be available for this trial as ethics approval has not been obtained for this.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20264Study protocol  [email protected] Study protocol can be obtained from the study coor... [More Details]
20265Ethical approval    Ethical approval, not yet available.



Results publications and other study-related documents

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