Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00139048




Registration number
NCT00139048
Ethics application status
Date submitted
28/08/2005
Date registered
30/08/2005
Date last updated
5/05/2017

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.
Secondary ID [1] 0 0
ASMDAT40
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knowledge of Mammography Screening 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Decision Aid

Behaviour: Decision Aid
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess the change in knowledge about the issues involved in screening mammography in women who have read the decision aid.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
elicit womens views on the decision aid including ease of use, content and presentation of information,
Timepoint [1] 0 0
Secondary outcome [2] 0 0
assess the differences in intention to screen
Timepoint [2] 0 0
Secondary outcome [3] 0 0
assess the impact of the decision aid on informed choice
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- female

- aged between 38-45

- have access to the internet
Minimum age
38 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Key exclusion criteria
-

Study design
Purpose of the study
Other
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Camperdown
Recruitment postcode(s) [1] 0 0
2006 - Camperdown

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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. 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00139048
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alex Barratt
Address 0 0
Screening and Test evaluation programme, School of Public Health, University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00139048