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Trial registered on ANZCTR


Registration number
ACTRN12605000573651
Ethics application status
Approved
Date submitted
26/09/2005
Date registered
4/10/2005
Date last updated
4/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The development and evaluation of two decision aids for individuals considering genetic testing for hereditary cancer.
Scientific title
The impact of two decision aids for individuals considering genetic testing for hereditary breast/ovarian cancer or hereditary non-polyposis colorectal cancer (HNPCC) on psychological and decision-related outcomes.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hereditary breast/ovarian cancer 699 0
Hereditary non-polyposis colorectal cancer (HNPCC). 700 0
Condition category
Condition code
Cancer 775 775 0 0
Breast
Cancer 776 776 0 0
Ovarian and primary peritoneal
Cancer 777 777 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to compare the efficacy of an educational pamphlet currently used in the clinical setting to that of the decision aids using two randomised controlled trials. The decision aids will be tested with two different samples: 120 individuals at high risk for HNPCC and 120 members of high-risk breast cancer families who approach one of six familial cancer clinics who have agreed to participate in this study (the familial cancer clinics in NSW: at Prince of Wales, Westmead, St Vincents Hospitals and Hunter Genetics, Newcastle, and in Victoria: at Royal Melbourne Hospital, and the Peter McCallum Cancer Institute). Participants will complete a questionnaire after they have read the decision aid or pamphlet, followed by a second questionnaire after 6 months.
Intervention code [1] 677 0
Behaviour
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 986 0
The primary outcome for the study is decisional conflict (measured by the Decisional Conflict Scale). This scale measures uncertainty about choosing among alternatives; modifiable factors contributing to uncertainty, such as being uninformed and unclear about values and feeling unsupported in decision-making, and perceptions of effectiveness of decision-making
Timepoint [1] 986 0
Assessed immediately after reading the information materials provided, and in the 6-month follow up questionnaire.
Secondary outcome [1] 1862 0
1: Knowledge of the genetic testing process and the pros and cons of genetic testing. Six true-false items were purposively designed for this study and assess knowledge about the testing process and the pros and cons of genetic testing.
Timepoint [1] 1862 0
This is assessed immediately after reading the information materials provided, and in the 6 month follow up questionnaire.
Secondary outcome [2] 1863 0
2: Informed Choice (measured by the Multidimensional Measure of Informed Choice). This scale classifies patients as having made an informed or uninformed choice. An informed choice is defined as one based on relevant knowledge, consistent with the decision-makers values and behaviourally implemented.
Timepoint [2] 1863 0
This is assessed immediately after reading the information materials provided, and in the 6 month follow up questionnaire.

Eligibility
Key inclusion criteria
To be eligible to participate in the study, patients must meet all the following criteria: (i) be at potentially high risk of breast/ovarian cancer (family history consistent with hereditary breast/ovarian cancer syndrome [National Breast Cancer Centre Category 3]) or HNPCC (family history consistent with HNPCC according to the revised Amsterdam criteria); (ii) be eligible for genetic testing, that is either be affected with cancer or, if unaffected, have a living, affected relative for whom mutation search would be appropriate; (iii) be able to give informed consent; (iv) be able to read English proficiently.
Men from HNPCC families will be included because the larger number of them (compared to breast/ovarian cancer families) will enable meaningful statistical analysis of their responses.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Men from breast cancer families will not be invited to participate because of the low number of men attending familial cancer clinics and because of the substantial differences in the needs of men attending these clinics compared to women.

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)
Clinicians receive their allocation of recruitment packages in consecutively numbered opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An internet based randomiser (Research Randomizer) was used to generate the sequence of controls and interventions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
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] 856 0
Charities/Societies/Foundations
Name [1] 856 0
The Cancer Council of NSW
Address [1] 856 0
Country [1] 856 0
Australia
Primary sponsor type
Individual
Name
Dr. Bettina Meiser
Address
Country
Secondary sponsor category [1] 723 0
Individual
Name [1] 723 0
Dr. Kathy Tucker
Address [1] 723 0
Country [1] 723 0
Secondary sponsor category [2] 724 0
Individual
Name [2] 724 0
Prof. Judy Kirk
Address [2] 724 0
Country [2] 724 0
Secondary sponsor category [3] 725 0
Individual
Name [3] 725 0
Ms. Claire Wakefield
Address [3] 725 0
Country [3] 725 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2121 0
Westmead Hospital: WSAHS Human Research Ethics Committee
Ethics committee address [1] 2121 0
Ethics committee country [1] 2121 0
Australia
Date submitted for ethics approval [1] 2121 0
Approval date [1] 2121 0
Ethics approval number [1] 2121 0
Ethics committee name [2] 2122 0
St Vincents Hospital: South Eastern Sydney Research Ethics Committee
Ethics committee address [2] 2122 0
Ethics committee country [2] 2122 0
Australia
Date submitted for ethics approval [2] 2122 0
Approval date [2] 2122 0
Ethics approval number [2] 2122 0
Ethics committee name [3] 2123 0
Royal Melbourne Hospital: Melbourne Health Human Research Ethics Committee
Ethics committee address [3] 2123 0
Ethics committee country [3] 2123 0
Australia
Date submitted for ethics approval [3] 2123 0
Approval date [3] 2123 0
Ethics approval number [3] 2123 0
Ethics committee name [4] 2124 0
Hunter Genetics: Hunter Area Research Ethics Committee
Ethics committee address [4] 2124 0
Ethics committee country [4] 2124 0
Australia
Date submitted for ethics approval [4] 2124 0
Approval date [4] 2124 0
Ethics approval number [4] 2124 0
Ethics committee name [5] 2125 0
Peter McCallum Cancer Institute Human Research Ethics Committee
Ethics committee address [5] 2125 0
Ethics committee country [5] 2125 0
Australia
Date submitted for ethics approval [5] 2125 0
Approval date [5] 2125 0
Ethics approval number [5] 2125 0

Summary
Brief summary
Background: The demand for genetic counselling and genetic testing for individuals with a family history of cancer is considerable and increasing. Current best practice in genetic counselling may not allow a full deliberation of the consequences of decisions about genetic testing for cancer susceptibility. Literature on risk perception in high-risk breast cancer families reveals persistent over-estimation of risk, even after counselling. In this study, two decision aids were designed to assist people deciding about genetic testing for cancer susceptibility. Methods: Stage 1. Two decision aids for individuals considering genetic testing for breast/ovarian cancer and hereditary non-polyposis colorectal cancer (HNPCC) susceptibility were developed and pilot tested with 25 women considering genetic testing for breast/ovarian cancer risk, and 18 individuals considering genetic testing for HNPCC risk. The aids were developed by a team of experts guided by expectancy-value decision theories and the literature on risk communication and the psychological impact of genetic testing. Stage 2: Involves two concurrent randomised controlled trials of the decision aids, each with 120 patients, assessed by questionnaire at two time points after genetic counselling. Results: Stage 1. Two 40 page two-colour decision aids were developed using varying formats of words, numbers, graphs, pie-charts and illustrations. Pilot testing results were positive, with all patients saying that they would recommend the decision aid to others facing the same situation, 93% reporting that the decision aid would have been relevant when they were making their decision about genetic testing and 84% of patients rating the amount of information contained as 'about right'. The decision aids were modified according to the results of the pilot testing. Stage 2 of the study is on-going. Preliminary results show that the decision aid may improve knowledge about genetic testing and may assist individuals to more accurately estimate their risk of developing cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36386 0
Address 36386 0
Country 36386 0
Phone 36386 0
Fax 36386 0
Email 36386 0
Contact person for public queries
Name 9866 0
Ms. Claire Wakefield
Address 9866 0
Psychosocial Research Group (PRG)
Department of Medical Oncology
Prince of Wales Hospital
Dickinson 3
Randwick NSW 2031
Country 9866 0
Australia
Phone 9866 0
+61 2 93824229
Fax 9866 0
+61 2 93823372
Email 9866 0
claire.wakefield@psy.mq.edu.au
Contact person for scientific queries
Name 794 0
Ms. Claire Wakefield
Address 794 0
Psychosocial Research Group (PRG)
Department of Medical Oncology
Prince of Wales Hospital
Dickinson 3
Randwick NSW 2031
Country 794 0
Australia
Phone 794 0
+61 2 93824229
Fax 794 0
+61 2 93823372
Email 794 0
claire.wakefield@psy.mq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results