Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000590763
Ethics application status
Approved
Date submitted
21/05/2013
Date registered
24/05/2013
Date last updated
24/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
To explore safety and feasibility of mobile teledermoscopy for Queensland residents 50-64 year of age at high risk for melanoma.
Scientific title
To explore safety, feasibility and acceptability of mobile teledermoscopy for Queensland residents 50-64 years at high risk for melanoma.
Secondary ID [1] 282538 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer
Melanoma 289205 0
Condition category
Condition code
Cancer 289534 289534 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After informed consent is sought and the baseline questionnaire completed, participants will be randomized by computer-generated random number list into the intervention [detailed Skin Self-Examination (SSE) instructions] or control groups (general SSE instructions).
Participants assigned to the intervention group will receive an information letter detailing an overview of the study, consent form, and reply paid envelope. Participants will keep the Handyscope dermatoscope for one month, and will be asked to complete one SSE, and then email their selected lesions of most concern to the dermatologist for evaluation.
Teledermoscopy materials

All participants will receive the following materials:
* Dermatoscope attachment;
* Instructions on dermatoscope functionality and how to email lesions for assessment;
* An information booklet describing how to assess lesions using the Asymmetry and Colour Rule for detecting melanoma to allow selection of concerning lesions for submission to the teledermatologist.

The detailed print-based instructions on how to conduct a thorough whole body SSE guiding participants towards hard to see areas such as the back or back of the neck and the use of two mirrors or utilising the assistance of a partner to visualise these areas, and are based on our previous studies (1).

(1) Janda M, Loescher L, Soyer PH. Enhanced skin self-examination – a novel approach to skin cancer monitoring and follow-up. Arch Dermatol (under review).
Intervention code [1] 287204 0
Early detection / Screening
Comparator / control treatment
Subjects assigned to the control group will receive an information letter detailing an overview of the study, consent form, and reply paid envelope. Participants will keep the Handyscope dermatoscope for one month, and will be asked to complete one SSE, and then email their selected lesions of most concern to the dermatologist for evaluation.

Teledermoscopy materials

All participants will receive the following materials:
* Dermatoscope attachment;
* Instructions on dermatoscope functionality and how to email lesions for assessment;
* An information booklet describing how to assess lesions using the Asymmetry and Colour Rule for detecting melanoma to allow selection of concerning lesions for submission to the teledermatologist.

The control instructions will ask participants to look for and photograph suspicious skin lesions, without specifying body areas to self-examine.
Control group
Active

Outcomes
Primary outcome [1] 289630 0
Primary Outcome: Safety and feasibility of mobile teledermoscopy for Queensland residents 50-64 years of age at high risk for melanoma. A follow-up survey after their SSE to assess (1) whether they found any suspicious lesions, (2) comfort level with the procedures, smartphone and dermatoscope, (3) satisfaction with the Asymmetry and Colour (AC) Rule and materials provided, (4) mobile teledermoscopy acceptance, self-efficacy and skin cancer worry.
Timepoint [1] 289630 0
One month after all participants have completed their SSE.
Secondary outcome [1] 302891 0
Assess the findings within the context of an existing technology acceptance model, and whether the technology acceptance model explains the intentions of people to use teledermoscopy in the future as well as their actual behaviour
Timepoint [1] 302891 0
One month after all participants have completed their SSE.

Eligibility
Key inclusion criteria
Inclusion criteria include: Male and female between 50-64 years of age in Queensland. Previous melanoma or skin cancer diagnosis, fair skin or high number of moles. In addition, stratified sampling will ascertain that 50% of participants will have a history of checking their own skin, whilst the other 50% will have no record of SSE. All participants must be able to speak English to give informed consent. Participants must have access to a smartphone.
Minimum age
50 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who do not have access to an iPhone, People who have cognitive impairment that prevents them from providing informed consent, People who do not speak English for informed consent, those living outside of Queensland and not available for a visit to QUT for a skin exam.

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)
QSkin participants have already completed questionnaires assessing the inclusive criteria. QSkin staff will select potentially eligible QSkin participants located in Brisbane (to allow for attending of clinical following-up skin examination), and at risk to develop skin cancer.
In addition to QSkin volunteers an announcement via internet and a television news outlet has been made for additional volunteers that fit the eligibility criteria.
Participants will be randomised allocated to two groups. The intervention group with SSE instructions and Control group with general SSE instructions will be supplied.

Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each consenting person from QSkin will be identified by their existing QSkin study number. Subjects will be randomised by computer-generated random number list into the intervention (detailed SSE instructions) or control groups (general SSE instructions).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to measure counts and percentages or means and standard deviations as appropriate and will assess internal consistency reliability of the adapted TeledermAM.
Linear regression analyses to assess the relationship between participants’ characteristics and smartphone factors and technology acceptance overall score and logistic regression models to assess intention to use or not to use teledermoscopy in the future.
Changes in teledermatology acceptance or melanoma worry from baseline to follow-up will be assessed using paired samples t-test.

The number of skin lesions photographed and submitted by participants who received detailed SSE instructions and those who received general instructions only will be summarised and compared using Chi-Square tests.

Unweighted Cohen’s kappa statistics will be used to measure agreement between teledermoscopy diagnosis and clinical diagnosis of lesions submitted by photographs.

Numbers consistent with usually requirements for a phase 1 safety and feasibility trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
2/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287320 0
University
Name [1] 287320 0
Queensland University of Technology (QUT),
Institute of Health and Biomedical Innovation (IHBI)
Country [1] 287320 0
Australia
Funding source category [2] 287321 0
Charities/Societies/Foundations
Name [2] 287321 0
PanPacific Skin Cancer Consortium
Country [2] 287321 0
United States of America
Primary sponsor type
University
Name
Queensland University of Technology (QUT), Institute of Health and Biomedical Innovation (IHBI)
Address
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059

Country
Australia
Secondary sponsor category [1] 286068 0
Charities/Societies/Foundations
Name [1] 286068 0
PanPacific Skin Cancer Consortium
Address [1] 286068 0
c/o The Atlantic Philanthropies (USA) Inc.
75 Varick Street, 17th floor
New York, NY 10013-1950
Tel: 212-916-7300
Fax: 212-922-0360
Country [1] 286068 0
United States of America
Other collaborator category [1] 277417 0
Government body
Name [1] 277417 0
Government funding body- Queensland Institute of Medical Research (QIMR)
Address [1] 277417 0
300 Herston Rd,
Herston, Queensland 4006
Country [1] 277417 0
Australia
Other collaborator category [2] 277418 0
University
Name [2] 277418 0
University of Queensland
Address [2] 277418 0
Brisbane St Lucia, QLD 4072, Australia
Country [2] 277418 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289292 0
Queensland Institute of Medical Research (QIMR)
Ethics committee address [1] 289292 0
Ethics committee country [1] 289292 0
Australia
Date submitted for ethics approval [1] 289292 0
Approval date [1] 289292 0
06/12/2012
Ethics approval number [1] 289292 0
P1309
Ethics committee name [2] 289293 0
Queensland University of Technology
Ethics committee address [2] 289293 0
Ethics committee country [2] 289293 0
Australia
Date submitted for ethics approval [2] 289293 0
Approval date [2] 289293 0
06/11/2012
Ethics approval number [2] 289293 0
1200000553
Ethics committee name [3] 289294 0
University of Queensland
Ethics committee address [3] 289294 0
Ethics committee country [3] 289294 0
Australia
Date submitted for ethics approval [3] 289294 0
Approval date [3] 289294 0
21/11/2012
Ethics approval number [3] 289294 0
#2012001250

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

Contacts
Principal investigator
Name 40082 0
A/Prof Monika Janda
Address 40082 0
Queensland University of Technology
School of Public Health & Social Work
O Block WING A - LEVEL 1 A112, Kelvin Grove, Brisbane
QLD 4059
Country 40082 0
Australia
Phone 40082 0
+61 7 3138 3018
Fax 40082 0
+61 7 3138 3130
Email 40082 0
[email protected]
Contact person for public queries
Name 40083 0
Monika Janda
Address 40083 0
Queensland University of Technology
School of Public Health & Social Work
O Block WING A - LEVEL 1 A112, Kelvin Grove, Brisbane
QLD 4059
Country 40083 0
Australia
Phone 40083 0
+61 7 3138 3018
Fax 40083 0
+61 7 3138 3130
Email 40083 0
[email protected]
Contact person for scientific queries
Name 40084 0
Monika Janda
Address 40084 0
Queensland University of Technology
School of Public Health & Social Work
O Block WING A - LEVEL 1 A112, Kelvin Grove, Brisbane
QLD 4059
Country 40084 0
Australia
Phone 40084 0
+61 7 3138 3018
Fax 40084 0
+61 7 3138 3130
Email 40084 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
SourceTitleYear of PublicationDOI
EmbaseA pilot trial of mobile, patient-performed teledermoscopy.2015https://dx.doi.org/10.1111/bjd.13550
N.B. These documents automatically identified may not have been verified by the study sponsor.