Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000013561p
Ethics application status
Submitted, not yet approved
Date submitted
20/11/2023
Date registered
10/01/2024
Date last updated
10/01/2024
Date data sharing statement initially provided
10/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Skin Lesion Awareness Personal Application (SLAPA) - Investigating the impact of smartphone app on skin cancer knowledge and prevention behaviour in adults
Scientific title
Design and validation of the Skin Lesion Awareness Personal Application (SLAPA) - Investigating the impact of a comprehensive, patient-centered skin cancer smartphone app on skin cancer knowledge and prevention behaviour in adults
Secondary ID [1] 310999 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
skin cancer 332105 0
Condition category
Condition code
Cancer 328829 328829 0 0
Malignant melanoma
Cancer 328830 328830 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will provide a randomized half of our cohort with the Skin Lesion Awareness Personal Application (SLAPA) mobile phone application. This application has been designed by the Plastic Surgical Department at Dunedin Hospital to help people learn about common skin lesions, teach them how to perform skin checks and prevent skin cancer.

The app's information will be delivered through infographics, text and the use of clinical photos to demonstrate lesions. The sections of the app are common skin lesions (covering melanoma, BCC, SCC, seborrheic keratosis, actinic keratosis, atypical naevus), prevention, self skin check, melanoma risk calculator, location-specific UV index, and how to seek help for skin lesions. The app also provides push notifications to a device that state the UV index and remind the user to protect themselves.

Participants in the SLAPA arm of the study will be given instruction on how to download and register for the app on their personal smartphones or tablet. They will be asked to read the content of the app at least once during the study which will take approximately 30 minutes to review in its entirety and leave the SLAPA app on their phone for the duration of the study (3 months).

Adherence/use of the intervention will be monitored through participants' self-reported questionnaires, which include questions about how often participants use the app in a week, approximate minutes of use a day and what their baseline familiarity with a smartphone is like. No app analytics will be used for the purpose of this study.
Intervention code [1] 327442 0
Behaviour
Intervention code [2] 327631 0
Treatment: Devices
Comparator / control treatment
A paper information pamphlet that was designed specifically for this study which contains comparable content as the SLAPA application will be provided to the control arm of the study.

The pamphlet will be printed and readily distributed by our research team (one surgical consultant and all registrars in Dunedin Hospital's plastic surgery department) in the face-to-face clinical setting or via mail if needed.

The pamphlet will take approximately 10 minutes to read.
Control group
Active

Outcomes
Primary outcome [1] 336633 0
Average score on skin cancer knowledge quiz
Timepoint [1] 336633 0
Baseline questionnaire (pre-intervention), 2 weeks, 6 weeks (primary timepoint), and 3 months post-randomization.
Secondary outcome [1] 429091 0
Incidence of sunburn.
Timepoint [1] 429091 0
Baseline questionnaire (pre-intervention), 2 weeks, 6 weeks, and 3 months post-randomization.
Secondary outcome [2] 429092 0
Percentage days SPF 50 sunscreen applied
Timepoint [2] 429092 0
Baseline questionnaire (pre-intervention), 2 weeks, 6 weeks, and 3 months post-randomization.
Secondary outcome [3] 429093 0
Percentage days in last 14 days of wearing brimmed hat
Timepoint [3] 429093 0
Baseline questionnaire (pre-intervention), 2 weeks, 6 weeks, and 3 months post-randomization.
Secondary outcome [4] 429094 0
Percentage days in last 14 days wearing protective clothing
Timepoint [4] 429094 0
Baseline questionnaire (pre-intervention), 2 weeks, 6 weeks, and 3 months post-randomization.
Secondary outcome [5] 429095 0
Hours spent outdoors in midday sun (1000-1600) in last 14 days
Timepoint [5] 429095 0
Baseline questionnaire (pre-intervention), 2 weeks, 6 weeks, and 3 months post-randomization.

Eligibility
Key inclusion criteria
Individuals who own smartphones AND are at high risk for skin cancer (individuals with previous T1A or greater melanoma and individuals immunocompromised by medications or haematological illnesses).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to consent for self.
Younger than 18 years of age.
Does not own a smartphone.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment with sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 25978 0
New Zealand
State/province [1] 25978 0
Otago

Funding & Sponsors
Funding source category [1] 315262 0
Government body
Name [1] 315262 0
Te Whatu Ora - Southern (Dunedin Hospital)
Country [1] 315262 0
New Zealand
Primary sponsor type
Individual
Name
Dr Anne Collins
Address
Te Whatu Ora - Southern, 201 Great King Street, Central Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 317296 0
None
Name [1] 317296 0
Address [1] 317296 0
Country [1] 317296 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314181 0
Southern Health and Disabilities Ethics Committee
Ethics committee address [1] 314181 0
Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140
Ethics committee country [1] 314181 0
New Zealand
Date submitted for ethics approval [1] 314181 0
18/12/2023
Approval date [1] 314181 0
Ethics approval number [1] 314181 0

Summary
Brief summary
Skin cancer is the most common cancer in Aotearoa New Zealand, accounting for 80% of all new cancers. Our study aims to show that a free mobile application which can be easily distributed nationwide will improve people’s awareness about skin cancer and prevention behaviors. Individuals enrolled in our study will be randomly given a paper-based skin cancer information pamphlet or access to the SLAPA application. Online questionnaires will assess participants' knowledge about skin cancer and how often they engage in prevention behaviors both at the start of the study and after receiving the information.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130698 0
Dr Anne Collins
Address 130698 0
Te Whatu Ora - Southern, 201 Great King Street, Central Dunedin, Dunedin 9016
Country 130698 0
New Zealand
Phone 130698 0
+64 027 8484 838
Fax 130698 0
Email 130698 0
Anne.Collins@southerndhb.govt.nz
Contact person for public queries
Name 130699 0
Dr Shelley Hubley
Address 130699 0
Te Whatu Ora - Southern, 201 Great King Street, Central Dunedin, Dunedin 9016
Country 130699 0
New Zealand
Phone 130699 0
+64 0224012300
Fax 130699 0
Email 130699 0
Shelley.Hubley@southerdhb.govt.nz
Contact person for scientific queries
Name 130700 0
Dr Shelley Hubley
Address 130700 0
Te Whatu Ora - Southern, 201 Great King Street, Central Dunedin, Dunedin 9016
Country 130700 0
New Zealand
Phone 130700 0
+64 0224012300
Fax 130700 0
Email 130700 0
Shelley.Hubley@southerndhb.govt.nz

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
20989Study protocol  Shelley.Hubley@southerdhb.govt.nz 386910-(Uploaded-14-12-2023-15-12-13)-Study-related document.pdf
20990Informed consent form  Shelley.Hubley@southerdhb.govt.nz 386910-(Uploaded-14-12-2023-15-14-20)-Study-related document.doc



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.