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Australian Screening Mammography Decision Aid Trial (ASMDAT)

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ClinicalTrials.gov Identifier: NCT00247442
Recruitment Status : Completed
First Posted : November 1, 2005
Last Update Posted : September 28, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Neoplasms Behavioral: Decision aid

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: An Evaluation of a Decision Aid for Women Aged Over 70 Considering Whether to Stop or Continue Having Mammography Screening.
Study Start Date : January 2006
Estimated Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Informed choice
  2. Participation

Secondary Outcome Measures :
  1. Decisional conflict
  2. Knowledge
  3. Anxiety

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247442


Locations
Australia, New South Wales
University of Sydney
Sydney, New South Wales, Australia, 2006
Sponsors and Collaborators
University of Sydney
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
More Information

ClinicalTrials.gov Identifier: NCT00247442     History of Changes
Other Study ID Numbers: CD-9999999
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: September 28, 2006
Last Verified: June 2005

Keywords provided by University of Sydney:
Mammography screening
Breast cancer screening
Screening outcomes
Decision aid
Decision support tool
Informed choice

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases