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Australian Screening Mammography Decision Aid Trial (ASMDAT)

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Decision aid
Sponsored by
University of Sydney
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Breast Neoplasms focused on measuring Mammography screening, Breast cancer screening, Screening outcomes, Decision aid, Decision support tool, Informed choice

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Sydney

Outcomes

Primary Outcome Measures

Informed choice
Participation

Secondary Outcome Measures

Decisional conflict
Knowledge
Anxiety

Full Information

First Posted
October 30, 2005
Last Updated
September 27, 2006
Sponsor
University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT00247442
Brief Title
Australian Screening Mammography Decision Aid Trial (ASMDAT)
Official Title
An Evaluation of a Decision Aid for Women Aged Over 70 Considering Whether to Stop or Continue Having Mammography Screening.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sydney

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Mammography screening, Breast cancer screening, Screening outcomes, Decision aid, Decision support tool, Informed choice

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
670 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Decision aid
Primary Outcome Measure Information:
Title
Informed choice
Title
Participation
Secondary Outcome Measure Information:
Title
Decisional conflict
Title
Knowledge
Title
Anxiety

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Davey, B.Psych, MPH
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nehmat Houssami, MBBS, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erin Mathieu, B.Ed, MPH
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Page, BA (Hons)
Organizational Affiliation
BreastScreen NSW
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Taylor, MBBS, PhD
Organizational Affiliation
BreastScreen NSW
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sian Smith, BSc (Hons)
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phyllis Butow, MPH, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2006
Country
Australia

12. IPD Sharing Statement

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Australian Screening Mammography Decision Aid Trial (ASMDAT)

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