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Trial registered on ANZCTR
Registration number
ACTRN12612000723886
Ethics application status
Approved
Date submitted
15/06/2011
Date registered
6/07/2012
Date last updated
6/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
A randomised controlled trial of an interactive decision aid for prostate cancer screening
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Scientific title
A randomised controlled trial of an online interactive decision aid applied to prostate cancer screening for men aged 40 to 69 years, assessing decision quality
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Secondary ID [1]
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None
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Universal Trial Number (UTN)
U1111-1121-9610
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Trial acronym
None
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
PSA testing for prostate cancer.
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Condition category
Condition code
Public Health
268189
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0
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Health promotion/education
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Public Health
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0
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Epidemiology
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Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
We have developed an online decision aid (‘My Prostate Cancer Screening Annalisa’) for men aged 40 to 69 years. The aid summarises the evidence for the benefits, potential harms and other factors associated with screening and elicits individual participant’s preferences for each factor associated with the decision to screen (the benefits, potential harms and other factors).
Responses to these questions are used to generate a personalised decision aid for the user.
There are two arms of the trial:
Control arm: Users are asked to indicate how important 5 attributes of prostate cancer screening (benefits and potential harms) are to them; these were pre-installed by researchers based on literature (RCT data) and a pilot study (i.e. the attributes are fixed). This arm is referred to as My Prostate Cancer Screening Annalisa: Fixed Attributes.
Intervention arm: Users are asked to choose the attributes they would like to include in their decision aid, from a total of 10 attributes. That is, users pick their own attributes. This arm is called My Prostate Cancer Screening Annalisa: You Choose. The control decision aid takes about 15 minutes to complete. The intervention decision aid takes about 18 minutes to complete.
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Intervention code [1]
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Early detection / Screening
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Intervention code [2]
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Prevention
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Comparator / control treatment
The comparator is the ‘fixed attribute’ interactive decision aid.
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Control group
Active
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Outcomes
Primary outcome [1]
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Primary outcome: Decision quality as measured by "MyDecisionQuality" an eight point scale that encompasses dimensions of making a high quality health decision.
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Assessment method [1]
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Timepoint [1]
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Baseline (after completion of interactive decision aid).
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Secondary outcome [1]
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Secondary Outcome 1: The proportion of the intervention and control group who indicate they are more likely to visit their GP to discuss PSA testing after interacting with either the 'Pick Your Own' (PYO) or Fixed Attribute (control group) decision aids. (The PYO version is where participants choose, from a list of 10 attributes, the ones they think are important to them). This will be assessed in the online questionnaire by asking participants to indicate how likely they are to see their GP about PSA testing before and after they use the appropriate decision aid.
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Assessment method [1]
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Timepoint [1]
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After interaction with the decision aid.
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Eligibility
Key inclusion criteria
40-69 year old men living in Australia who have access to the internet and a reasonable command of the English language.
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Minimum age
40
Years
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Maximum age
69
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
No access to the internet, insufficient English, younger than 40 years or older than 69 years.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Global Market Insite, Inc. (GMI) will recruit 1,398 participants from their panel of 130,000 Australians. Eligible participants who agree to be in the study will be randomly allocated to one of the two arms of the study. This is done centrally by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
For each of the three age strata simple randomisation is performed using a randomisation table created by computer software (i.e. computerised sequence generation).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
9/06/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
1398
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,ACT,QLD,SA,WA,NT,TAS
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC)
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Address [1]
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Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Professor Glenn Salkeld
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Address
A27 - Edward Ford Building
The University of Sydney
NSW 2006 Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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Individual
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Name [1]
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Dr Michelle Cunich
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Address [1]
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Sydney Medical School
Edward Ford Building (A27)
University of Sydney, NSW 2006
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Country [1]
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Australia
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Other collaborator category [2]
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Individual
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Name [2]
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Professor Emeritus Jack Dowie
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Address [2]
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Tavistock Place, London School of Hygiene and Tropical Medicine
London
15-17 Tavistock Place
WC1H 9SH UK
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Country [2]
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United Kingdom
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Other collaborator category [3]
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Individual
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Name [3]
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Dr Kirsten Howard
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Address [3]
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Sydney Medical School
Edward Ford Building (A27)
University of Sydney, NSW 2006
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Country [3]
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Australia
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Other collaborator category [4]
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Individual
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Name [4]
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Associate Professor Manish Patel
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Address [4]
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Westmead Hospital
PO Box 533
Wentworthville, NSW
2145
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Country [4]
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Australia
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Other collaborator category [5]
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Individual
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Name [5]
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Professor Graham Mann
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Address [5]
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Westmead Millennium Institute for Medical Research
PO Box 533
Wentworthville, NSW
2145
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Country [5]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
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Level 6
Jane Foss Russell Building (G02)
The University of Sydney,
NSW 2006
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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31/03/2011
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Approval date [1]
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02/06/2011
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Ethics approval number [1]
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05-2011/13712
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Summary
Brief summary
This study aims to evaluate an online interactive decision aid for prostate cancer screening. Who is it for? You can join this study if you are a male aged 40-69 years who lives in Australia. You must have access to the internet and a reasonable command of the English language. Trial details Participants in this trial will complete an online decision aid for prostate cancer screening. This easy to use interactive decision aid asks men to rate the importance of factors that are relevant to making a high quality decision, and to weigh up the potential benefits (e.g. avoiding the potential loss of lifetime by early detection of prostate cancer) and harms (e.g. false positive test results and unnecessary treatments) of PSA testing for prostate cancer. Participants will be randomly (by chance) assigned to one of two groups. One group will complete the 'Fixed Attributes' version of the decision aid and the other group will complete the 'You Choose' version. The usefulness of the decision aid will be assessed via a series of questions asking the respondents to rate aspects of the quality of the decision about prostate cancer screening.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Professor Glenn Salkeld
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Address
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Sydney Medical School
Edward Ford Building (A27)
University of Sydney, NSW 2006
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Country
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Australia
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Phone
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+61 2 9036 9262
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Fax
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+61 2 9036 9019
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Email
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[email protected]
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Contact person for scientific queries
Name
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Professor Glenn Salkeld
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Address
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Sydney Medical School
Edward Ford Building (A27)
University of Sydney, NSW 2006
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Country
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Australia
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Phone
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+61 2 9036 9262
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Fax
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+61 2 9036 9019
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
The role of personalised choice in decision support: A randomized controlled trial of an online decision aid for prostate cancer screening.
2016
https://dx.doi.org/10.1371/journal.pone.0152999
N.B. These documents automatically identified may not have been verified by the study sponsor.
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