Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001079831
Ethics application status
Approved
Date submitted
8/10/2012
Date registered
9/10/2012
Date last updated
15/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study of Community Jury for Prostate Cancer
Scientific title
In men aged between 50 and 70 years, is a community jury more effective than standard information in improving knowledge about prostate cancer testing and what information is the most informative?
Secondary ID [1] 281315 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patient attitudes towards prostate cancer testing 287529 0
Condition category
Condition code
Public Health 287851 287851 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Community jury (CJ) members interact, question experts and reflect on information. CJ members will convene on Day 1 for expert interaction about the pros and cons of prostate cancer testing. Experts from Urology and Evidence-based Medicine will hold a seminar session (approximately 1 hour each) after which participants will have an opportunity to ask questions before the next expert seminar. Both seminars will occur over a three hour period to allow for questions and answers and a short break. After both presentations a facilitator will assist the participants to reflect on the “evidence” and consider further questions that will be put to the experts in a panel forum in the afternoon. Overnight, participants will return to their homes to reflect on the information provided. Clarification of any further questions will occur on Day 2. Participants will be asked to form a consensus (majority decision) about whether to undertake prostate cancer screening; however each participant’s decision will be recorded for data collection. Participants will be requested to complete the post-assessment questionnaire after deliberations on Day 2.
Intervention code [1] 285815 0
Behaviour
Comparator / control treatment
After completion of the pre-assessment questionnaire, participants in this group will be distributed “information packs” about prostate cancer screening. Brochures will be sourced from organisations such as the Cancer Council Australia and Australian Prostate Cancer Collaboration. Participants will be recontacted on Day 2 and asked to complete the post-assessment questionnaire over the phone.
Control group
Active

Outcomes
Primary outcome [1] 288073 0
1. Knowledge and attitudes towards testing for prostate cancer
A short survey comprising both quantitative and qualitative questions was developed for the study. It will be administered at 3 time points to identify changes or maintenance to participants knowledge and attitudes towards testing for prostate cancer.
Timepoint [1] 288073 0
1. Pre-assessment, post-assessment and 3-month follow-up
Primary outcome [2] 288117 0
2. Salient information necessary for men to have informed consent
Community jury members will be asked to reflect on the information provided by the experts and discuss the information within the group. Participants will be asked for both their individual opinions and for a jury consensus regarding the most relevant information for men to know before deciding about whether they wished to be tested for prostate cancer. This data will be qualitative.
Timepoint [2] 288117 0
2. Post-assessment community jury members only
Secondary outcome [1] 299376 0
1. Hypothetical recommendations for prostate cancer testing.
This data will be collected using a consensus jury process and is qualitative. The jury will be asked to deliberate about hypothetical recommendations to be made to a Health Minister about prostate cancer testing (i.e., whether it should be government funded, promoted to community members, age recommendations, etc).
Timepoint [1] 299376 0
Post-assessment of community jury members only

Eligibility
Key inclusion criteria
Male
Minimum age
50 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous diagnosis of prostate cancer

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)
Participants will be recruited via print and radio media. A brief inclusion questionnaire will be administered over the telephone (age and cancer status) and the first 30 eligible participants will be invited to attend a 2 hour information session where further explanation of the study will be provided and consent requested. After consent, the pre-assessment questionnaire will be distributed to participants and completed immediately. Participants will be randomly assigned to 2 groups using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using opaque envelopes containing the randomised group name will be distributed to the participants after pre-assessment.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286070 0
University
Name [1] 286070 0
Bond University
Country [1] 286070 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Gold Coast, Queensland, Australia, 4229
Country
Australia
Secondary sponsor category [1] 284886 0
None
Name [1] 284886 0
Address [1] 284886 0
Country [1] 284886 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288160 0
Ethics committee address [1] 288160 0
Ethics committee country [1] 288160 0
Date submitted for ethics approval [1] 288160 0
08/10/2012
Approval date [1] 288160 0
Ethics approval number [1] 288160 0

Summary
Brief summary
Healthy men who are tested for prostate cancer are usually not informed of the potential harms of the screening process, such as overdiagnosis and overtreatment. The balance of benefits and harms in screening depends on individual risks and values, and prior research suggested men currently appear inadequately informed. This pilot study will use a randomised controlled trial to investigate the use of Community Jury (a “jury” who undergo 2 days of expert information, discussion and reflection) compared with a standard information group to investigate men's knowledge and attitudes towards prostate cancer testing. In additiion the Community Jury will be asked to recommend hypothethical policy issues regarding testing for prostate cancer in healthy men.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34769 0
Address 34769 0
Country 34769 0
Phone 34769 0
Fax 34769 0
Email 34769 0
Contact person for public queries
Name 18016 0
Rae Thomas
Address 18016 0
Bond University
Centre for Research in Evidence-Based Practice
Faculty of Health and Medical Science
Gold Coast, Queensland 4229
Country 18016 0
Australia
Phone 18016 0
+61 (0)7 5595 5521
Fax 18016 0
Email 18016 0
[email protected]
Contact person for scientific queries
Name 8944 0
Rae Thomas
Address 8944 0
Bond University
Centre for Research in Evidence-Based Practice
Faculty of Health and Medical Science
Gold Coast, Queensland, 4229
Country 8944 0
Australia
Phone 8944 0
+61 (0)7 5595 5521
Fax 8944 0
Email 8944 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIDeliberative democracy and cancer screening consent: a randomised control trial of the effect of a community jury on men's knowledge about and intentions to participate in PSA screening2014https://doi.org/10.1136/bmjopen-2014-005691
N.B. These documents automatically identified may not have been verified by the study sponsor.