Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000989448
Ethics application status
Approved
Date submitted
22/07/2016
Date registered
27/07/2016
Date last updated
25/06/2019
Date data sharing statement initially provided
25/06/2019
Date results information initially provided
25/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of using mobile teledermoscopy to conduct skin self-examinations in high risk melanoma adults
Scientific title
Comparing the use of mobile teledermoscopy to conduct skin self-examination versus usual naked-eye skin self-examination in high risk melanoma adults: a randomised trial
Secondary ID [1] 289631 0
None
Universal Trial Number (UTN)
Trial acronym
SKin INnovation (SKIN) Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin cancer (healthy volunteers) 299444 0
Condition category
Condition code
Cancer 299424 299424 0 0
Malignant melanoma
Cancer 299425 299425 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be loaned a mobile dermatoscope to conduct their skin self-examination. This is a magnifying device that attaches to a mobile phone with polarised light to aid skin examinations, which can store and send photos of skin moles to a dermatologist via an app.
Participants will be provided with an information booklet and video on how to set up the mobile dermatoscope and use the associated mobile application, known as "Handyscope." Participants will be conducting three skin self-examinations using mobile dermoscopy: at baseline, 1-month and 2-month timepoints. Participants will be asked to send photos of any skin lesions they believe are suspicious to the consultant dermatologist via the Handyscope application. Participants will be reminded to conduct their skin self-examinations via SMS or email.
Intervention code [1] 295264 0
Treatment: Devices
Intervention code [2] 295388 0
Early detection / Screening
Comparator / control treatment
Usual care: skin self-examinations conducted by the naked eye.
Participants will be conducting three naked-eye skin self-examinations at baseline, 1-month and 2-month timepoints.

The reference standard is a clinical skin examination conducted by a dermatologist. The clinical skin examination will be conducted at the follow-up visit, which will take place after the final 2-month skin self-examination. This follow-up visit will take approximately 1 hour and will be conducted by our consultant dermatologist (Professor H. Peter Soyer). During this visit, the dermatologist will conduct a clinical skin examination using dermoscopy, and diagnosing each suspicious lesion and determining the likelihood of malignancy and recommend a course of action.
Control group
Active

Outcomes
Primary outcome [1] 298892 0
Sensitivity
(Sensitivity of skin self-examination using mobile dermatoscope VERSUS skin self-examination using the naked eye. The reference standard is a clinical skin examination conducted by a dermatologist)
Timepoint [1] 298892 0
Baseline, 1 month and 2 months post-randomisation.
Primary outcome [2] 298893 0
Specificity
(Specificity of skin self-examination using mobile dermatoscope VERSUS skin self-examination using the naked eye. The reference standard is a clinical skin examination conducted by a dermatologist)
Timepoint [2] 298893 0
Baseline, 1 month and 2 months post-randomisation.
Secondary outcome [1] 325554 0
Cost-benefit analysis
- Quality-adjusted life years (QALYS)
- Willingness-to-pay for teledermoscopy diagnoses compared to standard care (This will be assessed using a questionnaire designed for this study)
Timepoint [1] 325554 0
Baseline and 2 months post-randomisation

Eligibility
Key inclusion criteria
- 18 years or older
- Participants with high risk of skin cancer (at least 2 of the following risk factors: high risk phenotype, family history of melanoma, personal history of non-melanoma skin cancer, history of skin excisions or many skin lesions)
- Own an iPhone 5 or above
- Have a partner, relative or friend available to assist with skin examinations
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- People who have been diagnosed with a melanoma within the last 5 years

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/01/2017
Actual
6/03/2017
Date of last participant enrolment
Anticipated
1/05/2018
Actual
7/06/2018
Date of last data collection
Anticipated
1/08/2018
Actual
31/08/2018
Sample size
Target
230
Accrual to date
Final
234
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 13587 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 294028 0
Government body
Name [1] 294028 0
NHMRC Partnership Grant
Country [1] 294028 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Cnr Musk and Victoria Park Rd
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 292851 0
University
Name [1] 292851 0
Dermatology Research Centre, University of Queensland
Address [1] 292851 0
37 Kent Street,
Woolloongabba QLD 4102
Country [1] 292851 0
Australia
Other collaborator category [1] 279075 0
Individual
Name [1] 279075 0
Professor H Peter Soyer
Address [1] 279075 0
Room 5081, Level 5
Dermatology Research Centre, The University of Queensland
Translational Research Centre (TRI)
37 Kent Street
Woolloongabba QLD 4102
Country [1] 279075 0
Australia
Other collaborator category [2] 279076 0
Individual
Name [2] 279076 0
Associate Professor Lois Loescher
Address [2] 279076 0
The University of Arizona
Colleges of Nursing & Public Health
PO Box 210203
Tuscon Arizona 85721-0203
Country [2] 279076 0
United States of America
Other collaborator category [3] 279077 0
Individual
Name [3] 279077 0
Dr Nicole Gillespie
Address [3] 279077 0
Faculty of Business, Economics and Law
The University of Queensland
St Lucia QLD 4072
Country [3] 279077 0
Australia
Other collaborator category [4] 279078 0
Individual
Name [4] 279078 0
Dr Dimitrios Vagenas
Address [4] 279078 0
Queensland University of Technology
Institute of Health Biomedical innovation (IHBI)
GOP Box 2434
Brisbane QLD 4001
Country [4] 279078 0
Australia
Other collaborator category [5] 279079 0
Individual
Name [5] 279079 0
Professor David Whiteman
Address [5] 279079 0
Queensland Institute of Medical Research (QIMR) Berghofer
Locked bag 2000
Royal Brisbane Hospital
Herston QLD 4029
Country [5] 279079 0
Australia
Other collaborator category [6] 279080 0
Individual
Name [6] 279080 0
Professor Mark Smithers
Address [6] 279080 0
The University of Queensland
School of Medicine
Mayne Medical School
288 Herston Road
Herston QLD 4006
Country [6] 279080 0
Australia
Other collaborator category [7] 279081 0
Individual
Name [7] 279081 0
Associate Professor Jenny Whitty
Address [7] 279081 0
University of East Anglia
Norwich Research Park
Norwich NR4 7TJ
Country [7] 279081 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295438 0
University Human Research Ethics Committee (QUT)
Ethics committee address [1] 295438 0
Level 4
88 Musk Avenue
Kelvin Grove QLD 4059
Ethics committee country [1] 295438 0
Australia
Date submitted for ethics approval [1] 295438 0
24/05/2016
Approval date [1] 295438 0
20/06/2016
Ethics approval number [1] 295438 0
1400000807

Summary
Brief summary
The purpose of this project is test whether mobile dermatoscopes can help assist consumers conduct home skin examinations to detect potentially cancerous skin spots or moles.

Who is it for?
You may be eligible to participate in this trial if you are aged 18 or over, are considered high risk for skin cancer, own an iPhone 5 or above and have a partner/relative/friend willing to assist you with skin examinations.

Study details:
Participants will be randomly allocated (by chance) to either the usual care naked-eye skin self-examination group or the intervention teledermoscopy group. The teledermoscopy group will receive a magnifying device which attaches to their smartphone to assist with skin self-examinations. All participants will be asked to complete two questionnaires (baseline and 2-month), conduct three skin examinations at home (baseline, 1-month and 2-month) and have a whole-body clinical skin examination with one of our study dermatologists at a study clinic after the 2-month skin self-examination. Intervention group will be asked to use a mobile dermatoscope to conduct their home skin examinations.

It is hoped that this trial will provide information on whether mobile teledermoscopy may be accurate and cost-effective for assisting high risk individuals with skin self-examinations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67254 0
Prof Monika Janda
Address 67254 0
Queensland University of Technology
School of Public Health and Social Work
O Block, Victoria Park Rd
Kelvin Grove QLD 4059
Country 67254 0
Australia
Phone 67254 0
+61 7 3138 3018
Fax 67254 0
Email 67254 0
[email protected]
Contact person for public queries
Name 67255 0
Ms Caitlin Horsham
Address 67255 0
Queensland University of Technology
School of Public Health and Social Work
O Block, Victoria Park Rd
Kelvin Grove QLD 4059
Country 67255 0
Australia
Phone 67255 0
+61 7 3138 8660
Fax 67255 0
Email 67255 0
[email protected]
Contact person for scientific queries
Name 67256 0
Ms Caitlin Horsham
Address 67256 0
Queensland University of Technology
School of Public Health and Social Work
O Block, Victoria Park Rd
Kelvin Grove QLD 4059
Country 67256 0
Australia
Phone 67256 0
+61 7 3138 8660
Fax 67256 0
Email 67256 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?

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
SourceTitleYear of PublicationDOI
EmbaseRedesigning skin cancer early detection and care using a new mobile health application: protocol of the skin research project, a randomised controlled trial.2018https://dx.doi.org/10.1159/000493729
EmbaseAccuracy of mobile digital teledermoscopy for skin self-examinations in adults at high risk of skin cancer: an open-label, randomised controlled trial.2020https://dx.doi.org/10.1016/S2589-7500%2820%2930001-7
N.B. These documents automatically identified may not have been verified by the study sponsor.