Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001019594
Ethics application status
Approved
Date submitted
11/09/2015
Date registered
30/09/2015
Date last updated
16/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Melanoma prevention in Australian primary care patients
Scientific title
Does personalised melanoma risk assessment and prevention information improve melanoma prevention behaviours in Australian primary care patients compared to general melanoma prevention information?
Secondary ID [1] 287455 0
Nil known
Universal Trial Number (UTN)
U1111-1174-2656
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma prevention 296177 0
Condition category
Condition code
Public Health 296455 296455 0 0
Health promotion/education
Cancer 296523 296523 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete a self-administered baseline questionnaire presented as a secure web-based application on a mobile small screen tablet, unassisted, in the general practice waiting room and receive general prevention information on melanoma- this will include information on what is melanoma, melanoma risk factors, primary and secondary prevention measures, and how to balance sun protection with the vitamin D levels. We anticipate the questionnaire will take approximately 5 to 10 minutes to complete. Additionally, intervention group participants will receive personalised melanoma risk information and prevention recommendations based on their risk levels. The personalised melanoma risk information and prevention recommendations will be based on the participant's self-assessed melanoma risk factors from the baseline questionnaire, and presented to the participant on the secure web-based application on a mobile small screen tablet which will also be printed out.
Intervention code [1] 292828 0
Prevention
Comparator / control treatment
General prevention information on melanoma. The general prevention information will be handed to the participants in the waiting room in the form of a booklet.
Control group
Active

Outcomes
Primary outcome [1] 296074 0
Number of participants that display improvement in melanoma prevention behaviours will be assessed by follow up questionnaire, which is specifically designed for this study.
Timepoint [1] 296074 0
6 to 12 weeks after intervention commencement
Primary outcome [2] 296076 0
Number of participants that display improvement in melanoma risk reduction intention will be assessed by follow up questionnaire, which is specifically designed for this study.
Timepoint [2] 296076 0
6 to 12 weeks after intervention commencement
Primary outcome [3] 296077 0
Number of participants that display improvement in melanoma risk perception will be assessed by follow up questionnaire, which is specifically designed for this study.
Timepoint [3] 296077 0
6 to 12 weeks after intervention commencement
Secondary outcome [1] 317445 0
Feasibility and practicality of use of the melanoma assessment in primary care setting will be assessed by measuring participation and repeat participation rates, reasons for non-participation, and time required to complete the questionnaires, review risk assessment and review the prevention recommendations assessed by review of application data.
Timepoint [1] 317445 0
At time of intervention to 6 to 12 weeks after intervention
Secondary outcome [2] 317446 0
Acceptability to patients of melanoma risk assessment in primary care will be assessed by questionnaire, which is specifically designed for this study.
Timepoint [2] 317446 0
At time of intervention to 6 to 12 weeks after intervention commencement
Secondary outcome [3] 317619 0
Acceptability to doctors of melanoma risk assessment in primary care setting will be assessed by questionnaire, which is specifically designed for this study.
Timepoint [3] 317619 0
At time of intervention to 6 to 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
To be eligible a patient must be aged over 18 years, have the capacity to give informed consent in English to answer the study questions.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with a current or previous history of melanoma will be excluded.

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)
Allocation will be concealed with central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study group allocation will be implemented using a blocked randomisation procedure, composed of randomly varied variable block sizes with stratification by sex and age by computer software.
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
Differences between intervention and control groups will be assessed using multivariable regression modelling. Adjusted mean values will be obtained with ANCOVA (one-way analysis of covariance). Data will be analysed on an intention-to-treat basis using SAS statistical software with a two-sided significance level set to 0.05.

We anticipate participation and repeat participation of 75%. Based on previous studies, where the standard deviation for their composite sun protection score (which includes information on seeking shade, sunscreen use, wearing sunglasses, wearing a hat and protective clothing) was 2.50 and the annual prevalence of clinical skin examination in the general population was 20%, the 196 of 265 enrolled participants who complete the follow up questionnaire would allow us to detect an average difference of 1.00 in the composite sun protection score and 20% in skin examination (each with 5% significance and 80% power).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/10/2015
Actual
16/02/2016
Date of last participant enrolment
Anticipated
29/04/2016
Actual
30/04/2016
Date of last data collection
Anticipated
Actual
15/11/2016
Sample size
Target
265
Accrual to date
Final
272
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292025 0
Other Collaborative groups
Name [1] 292025 0
Sydney Catalyst
Country [1] 292025 0
Australia
Funding source category [2] 292026 0
Other Collaborative groups
Name [2] 292026 0
The Primary Care Collaborative Cancer Clinical Trials Group
Country [2] 292026 0
Australia
Primary sponsor type
University
Name
Sydney School of Public Health, Sydney Medical School, University of Sydney
Address
University of Sydney
City Road
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 290695 0
Individual
Name [1] 290695 0
Dr Anne Cust
Address [1] 290695 0
Dr Anne Cust
Sydney School of Public Health, Sydney Medical School, University of Sydney
Chris O'Brien Lifehouse Building
Level 6, 119-143 Missenden Road
Camperdown NSW 2050
Country [1] 290695 0
Australia
Secondary sponsor category [2] 290696 0
Individual
Name [2] 290696 0
Dr Kylie Vuong
Address [2] 290696 0
Dr Kylie Vuong
Sydney School of Public Health, Sydney Medical School, University of Sydney
Chris O'Brien Lifehouse Building
Level 6, 119-143 Missenden Road
Camperdown NSW 2050
Country [2] 290696 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293512 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 293512 0
Ethics committee country [1] 293512 0
Australia
Date submitted for ethics approval [1] 293512 0
Approval date [1] 293512 0
28/06/2014
Ethics approval number [1] 293512 0
2014/144

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

Contacts
Principal investigator
Name 60242 0
Dr Kylie Vuong
Address 60242 0
Dr Kylie Vuong
Sydney School of Public Health, Sydney Medical School, University of Sydney
Chris O'Brien Lifehouse Building
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country 60242 0
Australia
Phone 60242 0
61 2 8627 1540
Fax 60242 0
Email 60242 0
[email protected]
Contact person for public queries
Name 60243 0
Kylie Vuong
Address 60243 0
Dr Kylie Vuong
Sydney School of Public Health, Sydney Medical School, University of Sydney
Chris O'Brien Lifehouse Building
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country 60243 0
Australia
Phone 60243 0
61 2 8627 1540
Fax 60243 0
Email 60243 0
[email protected]
Contact person for scientific queries
Name 60244 0
Kylie Vuong
Address 60244 0
Dr Kylie Vuong
Sydney School of Public Health, Sydney Medical School, University of Sydney
Chris O'Brien Lifehouse Building
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country 60244 0
Australia
Phone 60244 0
61 2 8627 1540
Fax 60244 0
Email 60244 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
No additional documents have been identified.