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Trial registered on ANZCTR


Registration number
ACTRN12605000695606
Ethics application status
Approved
Date submitted
21/10/2005
Date registered
28/10/2005
Date last updated
21/11/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Screening Mammography Decision Aid Trial (ASMDAT)
Scientific title
An evaluation of a decision aid for women aged 70 considering whether to stop or continue having mammography screening.
Secondary ID [1] 206 0
BreastScreen NSW
Universal Trial Number (UTN)
Trial acronym
ASMDAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 844 0
Condition category
Condition code
Cancer 911 911 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of the study is to develop and evaluate a decision aid to assist women aged 70 years and over to make an informed choice about whether to continue screening mammography, as part of the monitoring and evaluation program of BreastScreen NSW.

Women who are due their FIRST screening mammogram over the age of 70 will be randomly allocated into one of two groups, to receive either (a) Decision Aid -a paper based workbook and personal worksheet containing balanced information on the outcomes of screening mammography for women aged 70 years and older, steps to decision making and a values clarification exercise, or (b) standard BreastScreen NSW information material. Three weeks later, women in both groups will be followed up to find out if those who received the decision aid had better knowledge and more realistic expectations of the potential benefits and harms involved in screening mammography, and reduced decisional conflict about whether or not to continue screening mammograms. The impact of the decision aid on rates of participation in screening mammography among women aged 70 years and older will be followed up after three months.
Intervention code [1] 733 0
Other interventions
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1185 0
The primary outcomes of the study are to assess the impact of the decision aid on (1) the proportion of women who make an informed choice about whether to continue or stop having screening mammograms.
The trial consists of 3 surveys: (1) Baseline computer-assited telephone interview (CATI) survey for women recruited into the trial (taking approximately 15 minutes to complete); (2) Postal questionnaire (20 minutes to complete)- measuring decisional conflict, anxiety and knowledge. At this stage, women will be sent either the decision aid or standard care information; (3) CATI Survey (10 minutes to complete).
Timepoint [1] 1185 0
Three weeks after receiving the questionnaire/decision aid or usual care material, participants will be telephoned and asked questions about their decision or intentions regarding screening mammograms. The responses will be cross checked with BreastScreen NSW records to validate participation in screening.
Primary outcome [2] 1186 0
The primary outcomes of the study are to assess the impact of the decision aid on (2) the participation rates of screening among women aged 70 and older.
The trial consists of 3 surveys: (1) Baseline computer-assited telephone interview (CATI) survey for women recruited into the trial (taking approximately 15 minutes to complete); (2) Postal questionnaire (20 minutes to complete)- measuring decisional conflict, anxiety and knowledge. At this stage, women will be sent either the decision aid or standard care information; (3) CATI Survey (10 minutes to complete).
Timepoint [2] 1186 0
Three weeks after receiving the questionnaire/decision aid or usual care material, participants will be telephoned and asked questions about their decision or intentions regarding screening mammograms. The responses will be cross checked with BreastScreen NSW records to validate participation in screening.
Secondary outcome [1] 2170 0
(1) measure the effect of the decision aid support tool on women's decisional conflict, anxiety and knowledge about issues involved in screening mammography.
Timepoint [1] 2170 0
Measured three weeks after the decision aid or standard information is sent out.
Secondary outcome [2] 2171 0
(2) collect data to compare relationships between a woman's objective and perceived breast cancer risk, and her decision to continue or stop having screening mammograms.
Timepoint [2] 2171 0
Measured three weeks after the decision aid or standard information is sent out.

Eligibility
Key inclusion criteria
Women who are due their FIRST screening mammogram, and who have previously participated in screening mammography at BreastScreen NSW.
Minimum age
70 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women not sufficiently proficient in English to complete the CATI and read the decision aid / standard care information and postal questionnaire.Women with a personal history of breast cancer (invasive or pre-invasive).

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)
To ensure allocation concealment, the mailing lists will only be seen by persons not involved in data collection. Dynamic allocation means no one knows beforehand which ID's will be allocated to a particular intervention. Interviewers for the pre-questionnaire telephone surveys do not know which intervention a particular respondent will receive.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The dynamic (adaptive) random allocation method will be used for sequence generation. Participants are allocated to a treatment group by checking the allocation of similar participants already randomised, and allocating the next treatment group
Masking / blinding
Open (masking not 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1006 0
University
Name [1] 1006 0
Screening and Test Evaluation Program (University of Sydney)
Address [1] 1006 0
Edward Ford Building (A27) university of Sydney NSW 2006
Country [1] 1006 0
Australia
Primary sponsor type
University
Name
Screening and Test Evaluation Program (University of Sydney)
Address
Country
Australia
Secondary sponsor category [1] 867 0
Government body
Name [1] 867 0
BreastScreen NSW
Address [1] 867 0
RPA Hospital
Level 4 Jeffery House
Missenden Rd
Camperdown NSW 2050
Country [1] 867 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2318 0
NSW Department of Health Ethics Committee (DoHEC)
Ethics committee address [1] 2318 0
Ethics committee country [1] 2318 0
Australia
Date submitted for ethics approval [1] 2318 0
Approval date [1] 2318 0
Ethics approval number [1] 2318 0
Ethics committee name [2] 2319 0
Human Research Ethics Committee (University of Sydney)
Ethics committee address [2] 2319 0
Ethics committee country [2] 2319 0
Australia
Date submitted for ethics approval [2] 2319 0
Approval date [2] 2319 0
Ethics approval number [2] 2319 0

Summary
Brief summary
The purpose of this study is to develop and evaluate a decision aid to assist women aged 70 years and over to make an informed choice about whether to continue screening mammography.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35296 0
Address 35296 0
Country 35296 0
Phone 35296 0
Fax 35296 0
Email 35296 0
Contact person for public queries
Name 9922 0
Alexandra Barratt
Address 9922 0
Screening and Test Evaluation Program School of Public Health
University of Sydney
Edward Ford Building (A27)
Camperdown NSW 2006
Country 9922 0
Australia
Phone 9922 0
+61 2 93515103
Fax 9922 0
+61 2 93515049
Email 9922 0
alexb@health.usyd.edu.au
Contact person for scientific queries
Name 850 0
Alexandra Barratt
Address 850 0
Screening and Test Evaluation Program School of Public Health
University of Sydney
Edward Ford Building (A27)
Camperdown NSW 2006
Country 850 0
Australia
Phone 850 0
+61 2 93515103
Fax 850 0
+61 2 93515049
Email 850 0
alexb@health.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary