- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247442
Australian Screening Mammography Decision Aid Trial (ASMDAT)
An Evaluation of a Decision Aid for Women Aged Over 70 Considering Whether to Stop or Continue Having Mammography Screening.
Study Overview
Detailed Description
The primary aims 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 screening mammography, and (2) the participation rates of screening among women aged 70 years and older.
There are two secondary aims of the study. First, to measure the effect of the decision support tool on women's decisional conflict, anxiety, and knowledge about the issues involved in screening mammography. Second, to compare relationships between a woman's objective and perceived risk of breast cancer with her decision to continue or stop screening mammography.
Screening mammography is recommended for women aged 50-69 years but there is no recommendation for women aged 70 years and older. Therefore the decision to continue or stop having screening mammograms are largely dependent on the importance women place on the perceived benefits and harms of screening.
The decision aid is a paper workbook and worksheet containing information on the outcomes of screening mammography for women aged 70 years and older (based on a published model- Barratt et al. 2005), steps to decision making and values clarification exercise. Currently it is not known if a decision aid with information about the benefits and risks of screening mammography can help women aged 70 years and older to make an informed choice. In addition to delivering benefits to individual women in assisting them to to make an informed choice the decision aid may lead to benefits for service providers such as improved efficiency and cost-effectiveness of screening women in this age group. Thus the impact of a decision aid in the efficiency and cost-effectiveness of screening mammography is an important but untested hypothesis.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New South Wales
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Sydney, New South Wales, Australia, 2006
- University of Sydney
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women who are due their FIRST screening mammogram over the age of 70, and who have previously participated in screening mammography at BreastScreen NSW.
Exclusion Criteria:
- Inability to complete a telephone interview in English.
- Personal history of breast cancer (invasive and pre-invasive).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Participation
|
Informed choice
|
Secondary Outcome Measures
Outcome Measure |
---|
Anxiety
|
Decisional conflict
|
Knowledge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heather Davey, B.Psych, MPH, University of Sydney
- Principal Investigator: Nehmat Houssami, MBBS, PhD, University of Sydney
- Principal Investigator: Erin Mathieu, B.Ed, MPH, University of Sydney
- Principal Investigator: Andrew Page, BA (Hons), BreastScreen NSW
- Principal Investigator: Richard Taylor, MBBS, PhD, BreastScreen NSW
- Principal Investigator: Sian Smith, BSc (Hons), University of Sydney
- Principal Investigator: Phyllis Butow, MPH, PhD, University of Sydney
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD-9999999
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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