Breast NeoplasmsNCT00247442
Australian Screening Mammography Decision Aid Trial (ASMDAT)
A study testing Decision aid in people with Breast Neoplasms, run by University of Sydney at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Decision aid
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 670 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2006to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Women who are due their FIRST screening mammogram over the age of 70, and who have previously participated in screening mammography at BreastScreen NSW.
Who cannot join
- Inability to complete a telephone interview in English.
- Personal history of breast cancer (invasive and pre-invasive).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of a Decision Aid for Women Aged Over 70 Considering Whether to Stop or Continue Having Mammography Screening.
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Decision aid
- Keywords
- Mammography screening, Breast cancer screening, Screening outcomes, Decision aid, Decision support tool, Informed choice
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Informed choice
Participation
Secondary outcomes (3)
Decisional conflict
Knowledge
Anxiety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startJan 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 670 participants
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Investigators
- Heather Davey, B.Psych, MPH, Principal investigator, University of SydneyNehmat Houssami, MBBS, PhD, Principal investigator, University of SydneyErin Mathieu, B.Ed, MPH, Principal investigator, University of SydneyAndrew Page, BA (Hons), Principal investigator, BreastScreen NSWRichard Taylor, MBBS, PhD, Principal investigator, BreastScreen NSWSian Smith, BSc (Hons), Principal investigator, University of SydneyPhyllis Butow, MPH, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247442
- Sponsor's protocol ID
- CD-9999999
- Status last verified
- Jun 2005
- First submitted
- 30 Oct 2005
- Last updated
- 28 Sep 2006
- Results posted
- No
Publications
Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.
PubMed 38726892
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Decision Aid for Women Aged Over 70 Considering Whether to Stop or Continue Having Mammography Screening.
- ClinicalTrials.gov ID
- NCT00247442
- Acronym / sponsor ID
- CD-9999999
- Conditions
- Breast Neoplasms
- Keywords
- Mammography screening, Breast cancer screening, Screening outcomes, Decision aid, Decision support tool, Informed choice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 670 participants
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Apr 2006
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Women who are due their FIRST screening mammogram over the age of 70, and who have previously participated in screening mammography at BreastScreen NSW.
Key exclusion criteria (2 listed)
- Inability to complete a telephone interview in English.
- Personal history of breast cancer (invasive and pre-invasive).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aid | Behavioural | – |
Primary outcome
Informed choice
Participation
3 secondary outcomes
Decisional conflict
Knowledge
Anxiety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2006.
- Derived from this study: PubMed 38726892Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Davey, B.Psych, MPH principal investigator
University of Sydney
Nehmat Houssami, MBBS, PhD principal investigator
University of Sydney
Erin Mathieu, B.Ed, MPH principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Breast Neoplasms, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informed choice. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00247442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2006.