Knowledge of Mammography ScreeningNCT00139048
Australian Screening Mammography Decision Aid Trial: A Decision Aid for Women Aged 40 Thinking About Starting Mammography Screening
A study testing Decision Aid in people with Knowledge of Mammography Screening, run by University of Sydney at 1 site in Australia.
Trial summary
Women who access the website, are aged between 38-45 years and are considering screening mammograms will be randomized to either the Decision Aid (a booklet providing information and exercises to help them to make a decision about whether to having screening mammograms) group or the Control Group. Read more about this study
- Who is it for?
- Ages 38 to 45 years, women only
- Conditions the study is for
- Knowledge of Mammography Screening
- What is being tested?
- Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2005to Feb 2007
- 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 38 to 45 years
- Women only
- Adult
Who may be able to join
- female
- aged between 38-45
- have access to the internet
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of an On-line Decision Aid for Women Aged 40 Considering Whether to Have Screening Mammograms to Evaluate the Change in Knowledge Regarding Mammography Screening.
Women who access the website, are aged between 38-45 years and are considering screening mammograms will be randomized to either the Decision Aid (a booklet providing information and exercises to help them to make a decision about whether to having screening mammograms) group or the Control Group. The Decision Aid group will first read the decision aid, and then will be asked some demographic and knowledge questions. The control group will be asked the demographic and knowledge questions only. The control group will have access to the Decision Aid after they have completed the questions
- Conditions
- Knowledge of Mammography Screening
- Being tested
- Decision Aid
- Keywords
- informed choice, shared decision making, decision aid, mammography screening, decision support
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.
Assess the change in knowledge about the issues involved in screening mammography in women who have read the decision aid.
Secondary outcomes (3)
elicit womens views on the decision aid including ease of use, content and presentation of information,
assess the differences in intention to screen
assess the impact of the decision aid on informed choice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startSep 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knowledge of Mammography ScreeningStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Investigators
- Alex Barratt, Principal investigator, Screening and Test evaluation programme, School of Public Health, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139048
- Sponsor's protocol ID
- ASMDAT40
- Status last verified
- May 2017
- First submitted
- 28 Aug 2005
- Last updated
- 5 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of an On-line Decision Aid for Women Aged 40 Considering Whether to Have Screening Mammograms to Evaluate the Change in Knowledge Regarding Mammography Screening.
- ClinicalTrials.gov ID
- NCT00139048
- Acronym / sponsor ID
- ASMDAT40
- Conditions
- Knowledge of Mammography Screening
- Keywords
- informed choice, shared decision making, decision aid, mammography screening, decision support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 30 Aug 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.
Women who access the website, are aged between 38-45 years and are considering screening mammograms will be randomized to either the Decision Aid (a booklet providing information and exercises to help them to make a decision about whether to having screening mammograms) group or the Control Group. The Decision Aid group will first read the decision aid, and then will be asked some demographic and knowledge questions. The control group will be asked the demographic and knowledge questions only. The control group will have access to the Decision Aid after they have completed the questions
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 38 to 45 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female
- aged between 38-45
- have access to the internet
Key exclusion criteria (1 listed)
- -
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
Assess the change in knowledge about the issues involved in screening mammography in women who have read the decision aid.
3 secondary outcomes
elicit womens views on the decision aid including ease of use, content and presentation of information,
assess the differences in intention to screen
assess the impact of the decision aid on informed choice
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 5 May 2017.
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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.
Alex Barratt principal investigator
Screening and Test evaluation programme, School of Public Health, 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 Knowledge of Mammography Screening, 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 3 inclusion and 1 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 5 May 2017. 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?
Assess the change in knowledge about the issues involved in screening mammography in women who have read the decision aid.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2017.