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Trial registered on ANZCTR


Registration number
ACTRN12618001718235
Ethics application status
Approved
Date submitted
15/10/2018
Date registered
18/10/2018
Date last updated
18/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating two decision aids for Australian men to support informed choice about prostate cancer screening
Scientific title
Evaluating two decision aids for Australian men to support informed choice about prostate cancer screening
Secondary ID [1] 296298 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 309987 0
informed choice 309989 0
overdiagnosis 309991 0
Condition category
Condition code
Public Health 308757 308757 0 0
Health promotion/education
Cancer 308818 308818 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two decision aids designed and developed by researchers at the University of Sydney using evidence-based data applied to the Australian context. The team worked closely with a graphic designer to design and develop appropriate online version of the aids.
The full length decision aid (http://www.psatesting.org.au/home) is equivalent to 10 x A4 pages which translated to four screens online, and sub-screens. It presents information on screening outcomes and the expected frequency for each outcome, each illustrated by icon arrays (1000-person tools and a conceptual diagram of overdiagnosis) and comprehensive information about overdiagnosis.
The short decision aid (http://www.psatesting.org.au/info) is one double-sided A4 sheet or a single webpage. It contains similar key information but is simplified in text and table form only with no supporting graphic material. A summary table of outcomes (‘What happens over 20 years?’) comparing the options of screening versus not screening features in both versions.
New to these aids is quantified information on treatment side effects and inclusion of information about considering one's life expectancy in screening decisions.
A community sample of men will be recruited to participate in an online randomised controlled trial comparing the two decision aids. They will access the allocated decision aid online, at home, at the time that they complete the survey. The survey and decision aid will take approximately 15 minutes to complete. An image will appear at the end of the online decision aid instructing men to click on it to indicate that they clicked through all screens of the aid.
Intervention code [1] 312630 0
Behaviour
Comparator / control treatment
A short version of the patient decision aid.
Control group
Active

Outcomes
Primary outcome [1] 307737 0
A questionnaire was designed specifically for this study, using validated scales and items from our previous work evaluating a breast screening decision aid.

The primary outcome is a composite outcome: informed choice. Informed choice comprises 3 elements combining (1) adequate knowledge of screening outcomes, (2) consistency between a man’s attitude to screening (positive or negative), and (3) intention to have a PSA test.

To determine adequate knowledge, both conceptual and numeric knowledge of PSA screening outcomes (mortality benefit, overdiagnosis, and false positives) assessed using a competency-based approach (Hersch et al., 2014). The threshold to determine adequate knowledge for informed choice will be set at more than 50% of total available knowledge marks.

Attitudes towards PSA screening will be measured with a validated scale based on the construct of decisional balance, consisting of twelve items (six positive and six negative statements), each scored on a Likert-type scale of -2 to 2, forming a combined attitudes scale of -24 to 24 (Watson et al., 2006). Decisional balance is a summary measure that represents the relative strength of the perceived positive aspects of the PSA test (“pros”) versus the perceived negative aspects of the PSA test (“cons”). For informed choice, the threshold for a positive attitude will be set at greater than zero.

Intentions about undergoing PSA screening within the next two to three years will be determined via one variable in the questionnaire with five response options (definitely will to definitely will not). For informed choice, this item will be dichotomized with “definitely will” and “likely to” classified as positive intentions. Responses of “unsure”, “not likely to” and “definitely will not” will be combined as negative intentions.
Timepoint [1] 307737 0
Immediately following intervention
Secondary outcome [1] 352729 0
A questionnaire was designed specifically for this study, drawing on previous work evaluating a breast screening decision aid.
Acceptability of the decision aid, measured using 5-point rating scales (O'Connor & Cranney, 1996, 2002).
Participants asked to rate the length of the decision aid ("much too long" to "much too short"), balance in presentation of information about options ("clearly slanted towards screening" to "clearly slanted away from screening"), ease of understanding of the information ("strongly agree" to "strongly disagree"), and overall suitability for decision making ("strongly agree" to "strongly disagree").
Timepoint [1] 352729 0
Immediately following intervention
Secondary outcome [2] 352832 0
Anticipated decisional regret (Sandberg & Conner 2009).
Assessed by two items tapping inaction regret (“If I do NOT have PSA screening in the next few years, I may later wish I did” and “If I DO have PSA screening in the next few years, I may later wish I did NOT”). Responses scored on a Likert scale, 1 (“Strongly disagree”), to 5 (“Strongly agree”), with higher scores indicating greater regret.
Timepoint [2] 352832 0
Immediately following intervention
Secondary outcome [3] 352833 0
Perceived risk (Kasparian, Meiser, Butow, Simpson & Mann. 2009).
Assessed by two items: Participants rate their own chance of developing a prostate cancer relative to an average man who has the same risk as them, using a 5-point Likert scale from “Much lower” to “Much higher”. Participants also rate their chances of developing a prostate cancer in their lifetime on a 4-point Likert Scale from “No chance” to “High chance”.
Timepoint [3] 352833 0
Immediately following intervention
Secondary outcome [4] 352834 0
Perceived credibility of decision aid information
Assessed by Meyer’s (1998) 5-item credibility index, scored on a 5-point likert scale (1=“Can’t be trusted”, 5=“Can be trusted”). Overall credibility will be determined by calculating means of the items. A higher score will reflect higher perceived credibility.
Timepoint [4] 352834 0
Immediately following intervention
Secondary outcome [5] 352938 0
Qualitative outcome: Relevant issues in choosing, or not choosing, to have a PSA test
Open-ended telephone interviews with n=30 men.
Interview recordings will be transcribed verbatim and a comprehensive framework method will be used to analyse interview responses.
Timepoint [5] 352938 0
2-3 months following intervention
Secondary outcome [6] 352978 0
Qualitative outcome: Reactions to decision aids
Open-ended telephone interviews with n=30 men.
Interview recordings will be transcribed verbatim and a comprehensive framework method will be used to analyse interview responses.
Timepoint [6] 352978 0
2-3 months following intervention

Eligibility
Key inclusion criteria
Men eligible to participate if registered with the survey panel, accept an invitation to participate in the online questionnaire, and aged between 45 and 60 years, without a prostate cancer diagnosis.
Minimum age
45 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous prostate cancer diagnosis
Outside 45-60 years age bracket

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
27/06/2018
Date of last participant enrolment
Anticipated
Actual
26/07/2018
Date of last data collection
Anticipated
31/10/2018
Actual
Sample size
Target
3000
Accrual to date
Final
2993
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300890 0
Charities/Societies/Foundations
Name [1] 300890 0
Prostate Cancer Foundation of Australia
Country [1] 300890 0
Australia
Funding source category [2] 300925 0
Government body
Name [2] 300925 0
National Health and Medical Research Council
Country [2] 300925 0
Australia
Primary sponsor type
University
Name
Sydney School of Public Health
Address
Edward Ford Building A27
University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 300509 0
None
Name [1] 300509 0
Address [1] 300509 0
Country [1] 300509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301716 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 301716 0
Ethics committee country [1] 301716 0
Australia
Date submitted for ethics approval [1] 301716 0
15/02/2018
Approval date [1] 301716 0
01/06/2018
Ethics approval number [1] 301716 0
2018/165

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

Contacts
Principal investigator
Name 87710 0
Prof Kirsten McCaffery
Address 87710 0
Rm 128B Edward Ford Building A27
University of Sydney
Camperdown NSW 2006
Country 87710 0
Australia
Phone 87710 0
+61293517220
Fax 87710 0
Email 87710 0
[email protected]
Contact person for public queries
Name 87711 0
Kirsten McCaffery
Address 87711 0
Rm 128B Edward Ford Building A27
University of Sydney
Camperdown NSW 2006
Country 87711 0
Australia
Phone 87711 0
+61293517220
Fax 87711 0
Email 87711 0
[email protected]
Contact person for scientific queries
Name 87712 0
Kirsten McCaffery
Address 87712 0
Rm 128B Edward Ford Building
University of Sydney
Camperdown NSW 2006
Country 87712 0
Australia
Phone 87712 0
+61293517220
Fax 87712 0
Email 87712 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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