Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247442
Status:
COMPLETED
Last Update Posted:
2006-09-28
First Post:
2005-10-30
Brief Title:
Australian Screening Mammography Decision Aid Trial ASMDAT
Sponsor:
University of Sydney
Organization:
University of Sydney
Study Overview
Official Title:
An Evaluation of a Decision Aid for Women Aged Over 70 Considering Whether to Stop or Continue Having Mammography Screening
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens decisional conflict anxiety and knowledge about the issues involved in screening mammography Second to compare relationships between a womans 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
There are two secondary aims of the study First to measure the effect of the decision support tool on womens decisional conflict anxiety and knowledge about the issues involved in screening mammography Second to compare relationships between a womans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None