None listed
Conditions
Brief summary
This trial looks at the effectiveness of a 'decision aid' as a means of improving informed consent for women invited to participate in a breast cancer prevention trial (IBIS-II). Who is it for? You can join this study if you are a woman who has had ductal carcinoma in situ (DCIS) or if you have a strong family history of breast cancer, and are considering joining the IBIS-II trial. (This is a study evaluating the role of anastrozole - a drug designed to reduce the hormone oestrogen in the body, in order to reduce the risk of developing invasive breast cancer.) Trial details Participants will be randomly divided into two groups. One group will receive a decision aid plus the standard information sheet, and the other group will receive the standard information sheet alone. The aim of the study is to discover whether a purpose-designed decision aid will increase women's understanding, and make it easier for them to make a decision which fits with their beliefs and values. Standard information includes clear factual information about the disease. A decision aid also provides clear factual information but adds more graphs and pictures and leads the woman through a process of weighing up the pros and cons of trial participation. If this study is successful, decision aids may be used more widely to help people decide whether or not to join a clinical trial.
Interventions
Women considering participation in IBIS-II will be randomised to receive a decision aid (intervention group) or a blank notebook (control group). The decision aid is a booklet containing clear written and graphical information, as well as exercises to help with the process of weighing up the pros and cons of possible risk management options, including joining IBIS-II. Participants usually take approximately 2 weeks to choose whether to take part in IBIS-II, however, they can make such a decision
Women considering participation in IBIS-II will be randomised to receive a decision aid (intervention group) or a blank notebook (control group). The decision aid is a booklet containing clear written and graphical information, as well as exercises to help with the process of weighing up the pros and cons of possible risk management options, including joining IBIS-II. Participants usually take approximately 2 weeks to choose whether to take part in IBIS-II, however, they can make such a decision at any point during which the trial is open for recruitment. Participation in the study involves filling out two questionnaires over a 3 month period. The study is expected to conclude mid 2009.
Sponsors
Medical Psychology Research Unit, University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients who are eligible for the IBIS-II trial will be eligible for the decision aid trial. These are either women at elevated risk of breast cancer, or women who have been treated for DCIS, aged between 40 and 70 years.
Exclusion criteria
Insufficient English to read the booklet and complete questionnaires.
Outcome results
None listed