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Trial registered on ANZCTR


Registration number
ACTRN12605000506695
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
26/09/2005
Date last updated
27/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving informed consent to clinical trials: Evaluating a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II).
Scientific title
Improving informed consent: A randomised controlled trial of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II).
Secondary ID [1] 280920 0
None
Universal Trial Number (UTN)
Trial acronym
IBIS-II DA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Level of informed consent in women considering joining IBIS-II (i.e. women with DCIS and at elevated risk of breast cancer). 631 0
Condition category
Condition code
Cancer 703 703 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 612 0
None
Comparator / control treatment
Women in the control group will receive a blank notebook.
Control group
Active

Outcomes
Primary outcome [1] 856 0
Satisfaction and difficulties with decision making (decisional conflict) measured using the validated Decisional Conflict Scale (DCS).
Timepoint [1] 856 0
Assessed immediately after women decide whether to take part in IBIS-II.
Secondary outcome [1] 1717 0
General knowledge about clinical trials measured using an adapted form of an existing scale. Understanding and attitudes relating to participation in IBIS-II measured using a scale developed specifically for this study and the Quality of Informed Consent (QuIC-B) scale. Anxiety measured using a short-form of the State-Triat Anxiety Inventory (STAI).
Timepoint [1] 1717 0
Assessed immediately after women decide whether to take part in IBIS-II.
Secondary outcome [2] 1718 0
Clinician/recruiter attitudes to decision aids measured using a scale developed by Annete O'Connor and her group used to survery Canadian clinicians about a specific DA.
Timepoint [2] 1718 0
Assessed at the end of the decision aid trial. The trial is expected to conclude mid 2009.
Secondary outcome [3] 1719 0
c) the effect of the decision aid on patient accrual to, and drop-out from, the IBIS-II trial.
Timepoint [3] 1719 0
Assessed at the end of the decision aid trial.
Secondary outcome [4] 8441 0
Decisional regret and satisfaction measured with the Decisional Regret Scale and the Satisfaction with Decision Scales respectively.
Timepoint [4] 8441 0
Assessed 12 weeks after the women have made a deicison whether or not to take pat in IBIS-II.

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Insufficient English to read the booklet and complete questionnaires.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Randomised block design
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment outside Australia
Country [1] 225 0
New Zealand
State/province [1] 225 0

Funding & Sponsors
Funding source category [1] 778 0
Charities/Societies/Foundations
Name [1] 778 0
Susan G Komen Breast Cancer Foundation
Address [1] 778 0
5005 LBJ Freeway,
Suite 250
Dallas, TX 75244
Country [1] 778 0
United States of America
Primary sponsor type
University
Name
Medical Psychology Research Unit, University of Sydney
Address
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 644 0
Other Collaborative groups
Name [1] 644 0
ANZ BCTG
Address [1] 644 0
Department of Surgical Oncology
University of Newcastle
Calvary Mater Newcastle
Locked Bag 7
Hunter Region Mail Centre NSW 2310
Country [1] 644 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2053 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 2053 0
Ethics committee country [1] 2053 0
Australia
Date submitted for ethics approval [1] 2053 0
Approval date [1] 2053 0
Ethics approval number [1] 2053 0
Ethics committee name [2] 5114 0
Hunter New England HREC
Ethics committee address [2] 5114 0
Ethics committee country [2] 5114 0
Australia
Date submitted for ethics approval [2] 5114 0
Approval date [2] 5114 0
Ethics approval number [2] 5114 0
Ethics committee name [3] 5115 0
Sir Charles Gairdner Hospital HREC
Ethics committee address [3] 5115 0
Ethics committee country [3] 5115 0
Australia
Date submitted for ethics approval [3] 5115 0
Approval date [3] 5115 0
Ethics approval number [3] 5115 0
Ethics committee name [4] 5116 0
St Vincent's Hospital Sydney HREC
Ethics committee address [4] 5116 0
Ethics committee country [4] 5116 0
Australia
Date submitted for ethics approval [4] 5116 0
Approval date [4] 5116 0
Ethics approval number [4] 5116 0
Ethics committee name [5] 5117 0
Mental Health Research and Ethics Committee
Ethics committee address [5] 5117 0
Ethics committee country [5] 5117 0
Australia
Date submitted for ethics approval [5] 5117 0
Approval date [5] 5117 0
Ethics approval number [5] 5117 0
Ethics committee name [6] 5118 0
Greenslopes Private Hospital HREC
Ethics committee address [6] 5118 0
Ethics committee country [6] 5118 0
Australia
Date submitted for ethics approval [6] 5118 0
Approval date [6] 5118 0
Ethics approval number [6] 5118 0
Ethics committee name [7] 5119 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [7] 5119 0
Ethics committee country [7] 5119 0
Australia
Date submitted for ethics approval [7] 5119 0
Approval date [7] 5119 0
Ethics approval number [7] 5119 0
Ethics committee name [8] 5120 0
Northern Y Ethics Committee
Ethics committee address [8] 5120 0
Ethics committee country [8] 5120 0
New Zealand
Date submitted for ethics approval [8] 5120 0
Approval date [8] 5120 0
Ethics approval number [8] 5120 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36076 0
Address 36076 0
Country 36076 0
Phone 36076 0
Fax 36076 0
Email 36076 0
Contact person for public queries
Name 9801 0
Dr Ilona Juraskova
Address 9801 0
Medical Psychology Research Unit
School of Psychology
University of Sydney
Brennan McCallum Building A18
NSW 2006
Country 9801 0
Australia
Phone 9801 0
+61 2 90365275
Fax 9801 0
+61 2 90365292
Email 9801 0
ilonaj@psych.usyd.edu.au
Contact person for scientific queries
Name 729 0
Professor Phyllis Butow
Address 729 0
Medical Psychology Research Unit
School of Psychology
University of Sydney
Brennan McCallum Building A18
NSW 2006
Country 729 0
Australia
Phone 729 0
+61 2 93512859
Fax 729 0
+61 2 90365292
Email 729 0
phyllisb@psych.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary