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Trial registered on ANZCTR


Registration number
ACTRN12607000084482
Ethics application status
Approved
Date submitted
19/12/2006
Date registered
24/01/2007
Date last updated
4/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the usefulness of a decision aid in patients with advanced colorectal or breast cancer
Scientific title
When the treatment goal is not cure: A randomised controlled trial of enhanced patient achievement of information and involvement preferences and more active involvement in treatment decision-making following the use of decision aids in patients with advanced colorectal or breast cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients newly diagnosed with advanced breast cancer 1576 0
Patients newly diagnosed with advanced colorectal cancer 1577 0
Condition category
Condition code
Cancer 1678 1678 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 1679 1679 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of a decision aid during the consultation by the medical oncologist and provision of the decision aid and audiotape for patient to take home. The decision aid contains information on potential managment decisions, risks and benefits of treatment options, side effects, treatment regimes, survival statistics, pros and cons of choices. The duration of use of the DA in the consultation is not set, it may be used as long as is required. The audiotapes is a recording of the content of the booklet. Participants may listen or read the decision aid as often as they wish and the DA and audiotape are theirs to keep.
Consultation length is as long as required.
Intervention code [1] 1016 0
Other interventions
Comparator / control treatment
Controls receive standard consultation discussing treatment options.
Consultation length is as long as required.
Control group
Active

Outcomes
Primary outcome [1] 2324 0
Enhanced patient achievement of information and involvement preferences and more active involvement in treatment decision-making following use of the decision aid.
Timepoint [1] 2324 0
Measured immediately post consultation and 2 weeks post decision.
Secondary outcome [1] 4056 0
Understanding of prognosis, treatment goals and side effects
Timepoint [1] 4056 0
measured immedicatley post consultation, 2 weeks post decision and one month post decision
Secondary outcome [2] 4057 0
patient anxiety levels
Timepoint [2] 4057 0
measured immedicatley post consultation, 2 weeks post decision and one month post decision
Secondary outcome [3] 4058 0
patient satisfaction with consultation and decision-making
Timepoint [3] 4058 0
measured immedicatley post consultation, 2 weeks post decision and one month post decision
Secondary outcome [4] 4059 0
doctor satisfaction with treatment decision-making
Timepoint [4] 4059 0
measured immedicatley post consultation, 2 weeks post decision and one month post decision

Eligibility
Key inclusion criteria
Inclusion: patients newly diagnosed with metastatic colorectal or breast cancer.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion: insufficient English, spoken and comprehension, current psychiatric diagnosis

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)
Using sequentially numbered opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random permuted blocks were constructed using a random number table. Randomisation was stratified by oncologist.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
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)

Funding & Sponsors
Funding source category [1] 1824 0
Charities/Societies/Foundations
Name [1] 1824 0
Cancer Council NSW
Address [1] 1824 0
The Cancer Council NSW
153 Dowling Street
Woolloomooloo, NSW 2011
PO Box 572
Kings Cross NSW 1340
Australia
Ph (+61 2) 9334 1900
Fax (+61 2) 9358 1452
Country [1] 1824 0
Australia
Primary sponsor type
University
Name
Medical Psychology Research Unit, University of Sydney
Address
Kings Cross NSW 1340
Australia
Ph (+61 2) 9334 1900
Fax (+61 2) 9358 1452
Country
Australia
Secondary sponsor category [1] 1644 0
None
Name [1] 1644 0
Nil
Address [1] 1644 0
Country [1] 1644 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3411 0
Royal Prince Alfred Hospital
Ethics committee address [1] 3411 0
Ethics committee country [1] 3411 0
Australia
Date submitted for ethics approval [1] 3411 0
Approval date [1] 3411 0
01/08/2005
Ethics approval number [1] 3411 0
X00-292 then X05-0147
Ethics committee name [2] 3412 0
Concord Hospital
Ethics committee address [2] 3412 0
Ethics committee country [2] 3412 0
Australia
Date submitted for ethics approval [2] 3412 0
Approval date [2] 3412 0
18/06/2001
Ethics approval number [2] 3412 0
CH62/6/2001-036
Ethics committee name [3] 3413 0
Prince of Wales Hospital
Ethics committee address [3] 3413 0
Ethics committee country [3] 3413 0
Australia
Date submitted for ethics approval [3] 3413 0
Approval date [3] 3413 0
14/01/2004
Ethics approval number [3] 3413 0
03/279
Ethics committee name [4] 3414 0
Westmead Hospital
Ethics committee address [4] 3414 0
Ethics committee country [4] 3414 0
Australia
Date submitted for ethics approval [4] 3414 0
Approval date [4] 3414 0
26/03/2003
Ethics approval number [4] 3414 0
2003/2/4.15 (1594)
Ethics committee name [5] 3415 0
Peter MacCallum Hospital
Ethics committee address [5] 3415 0
Ethics committee country [5] 3415 0
Australia
Date submitted for ethics approval [5] 3415 0
Approval date [5] 3415 0
22/07/2004
Ethics approval number [5] 3415 0
04/13

Summary
Brief summary
We have developed two user-friendly decision aids (DAs) for patients with incurable breast or bowel cancer. These include an instrument used by doctor and patient in the consultation, and a take-home booklet and audiotape for patients. The DAs outline treatment options, benefits and likely side effects. Information is presented in different visual formats. This should help patients participate in their cancer treatment decisions. Patients and doctors have reviewed the DAs, and their usefulness will now be tested in a randomised trial.

Hypotheses being examined in this study (in the randomised trial): Patients receiving DAs at the time of making a treatment decision about management of advanced cancer compared to patients not receiving DAs at this time will have enhanced achievement of their involvement preference, participate in decision-making more actively and have improved understanding of their prognosis, treatment goals and side effects, as well as be more satisfied with their care. Doctors using the DAs in consultations will have enhanced satisfaction with treatment decision-making.

This project is also being run in Toronto, Canada. The recruitment target of 210 includes 105 from Canada. Recruitment is complete in all sites and analysis is underway.
Trial website
Trial related presentations / publications
Publications
Chiew, K. S., Shepherd, H., Vardy, J., Tattersall, M. H. N., Butow, P. N. and Leighl, N. B. (2008) Health Expectations, 11, 35-45.

Conference Presentations
July 2007 When the goal of treatment is not cure: a randomized trial of a patient decision aid in advanced colorectal cancer American Society of Clinical Oncology (ASCO) Chicago USA. Oral Presentation

Jan 2007 Randomized trial of a decision aid for patients with metastatic colon cancer considering first-line systemic therapy. Gastrointestinal Cancer Symposium, Orlando, USA. Poster presentation.
Public notes

Contacts
Principal investigator
Name 36302 0
Address 36302 0
Country 36302 0
Phone 36302 0
Fax 36302 0
Email 36302 0
Contact person for public queries
Name 10205 0
Heather Shepherd
Address 10205 0
Medical Psychology Research Unit (MPRU)
University of Sydney
Blackburn Building (D06)
NSW 2006
Country 10205 0
Australia
Phone 10205 0
+61 2 90365419
Fax 10205 0
+61 2 90365420
Email 10205 0
heathers@med.usyd.edu.au
Contact person for scientific queries
Name 1133 0
Professor Phyllis Butow
Address 1133 0
Medical Psychology Research Unit (MPRU)University of Sydney
Blackburn Building (D06)
NSW 2006
Country 1133 0
Australia
Phone 1133 0
+61 2 93512859
Fax 1133 0
Email 1133 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