Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000293662
Ethics application status
Approved
Date submitted
26/08/2005
Date registered
5/09/2005
Date last updated
18/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian screening mammography decision aid trial: A decision aid for women aged 40 thinking about starting mammography screening
Scientific title
A randomised controlled trial of an on-line decision aid for women aged 40 considering whether to have screening mammograms to evaluate the change in knowledge regarding mammography screening.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knowledge of mammography screening and breast cancer 381 0
Condition category
Condition code
Cancer 452 452 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women who access the website, are aged between 38-45 years and are considering screening mammograms will be randomized to either the Decision Aid (a booklet providing information and exercises to help them to make a decision about whether to having screening mammograms) group or the Control Group. The Decision Aid group will first read the decision aid, and then will be asked some demographic and knowledge questions.
Intervention code [1] 279 0
Other interventions
Comparator / control treatment
The control group will be asked the demographic and knowledge questions only. The control group will have access to the Decision Aid after they have completed the questions.
Control group
Placebo

Outcomes
Primary outcome [1] 513 0
To assess the change in knowledge about the issues involved in screening mammography in women who have read the decision aid.
Timepoint [1] 513 0
Immediately after reading intervention/completing questions.
Secondary outcome [1] 1103 0
Secondary aims are to elicit womens views on the decision aid including the ease of use, content and presentation of information, assess the differences in intention to screen and the impact of the decision aid on informed choice.
Timepoint [1] 1103 0
Immediately after reading intervention/completing questions.

Eligibility
Key inclusion criteria
Have access to the internet.
Minimum age
38 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Central randomisation by on-line recruitment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated simple randomisation (no restriction)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 501 0
Government body
Name [1] 501 0
NHMRC
Country [1] 501 0
Australia
Primary sponsor type
University
Name
Screening and Test Evaulation Programme
Address
Edward Ford Building
A27
University of Sydney
Camperdown New South Wales 2006
Country
Australia
Secondary sponsor category [1] 410 0
University
Name [1] 410 0
School of Public Health, University of Sydney
Address [1] 410 0
University of Sydney
Country [1] 410 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1483 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 1483 0
Ethics committee country [1] 1483 0
Australia
Date submitted for ethics approval [1] 1483 0
Approval date [1] 1483 0
Ethics approval number [1] 1483 0

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

Contacts
Principal investigator
Name 36052 0
Address 36052 0
Country 36052 0
Phone 36052 0
Fax 36052 0
Email 36052 0
Contact person for public queries
Name 9468 0
Erin Mathieu
Address 9468 0
University of Sydney
A27 Edward Ford Building
Camperdown NSW 2006
Country 9468 0
Australia
Phone 9468 0
+61 2 93514384
Fax 9468 0
+61 2 93515049
Email 9468 0
erinm@health.usyd.edu.au
Contact person for scientific queries
Name 396 0
Erin Mathieu
Address 396 0
University of Sydney
A27 Edward Ford Building
Camperdown NSW 2006
Country 396 0
Australia
Phone 396 0
+61 2 93514384
Fax 396 0
+61 2 93515049
Email 396 0
erinm@health.usyd.edu.au

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.