Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000316404
Ethics application status
Approved
Date submitted
7/06/2007
Date registered
14/06/2007
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Genetic Risk Information Disclosure study.
Scientific title
A prospective, multicentre, open, parallel group, randomised controlled trial to evaluate the effectiveness of passive versus active disclosure of genetic information to those at risk of familial cancer.
Secondary ID [1] 288004 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GRID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genetic mutations predisposing to breast, ovarian or colorectal cancer and methods of disclosing that information to relatives. 1862 0
Condition category
Condition code
Cancer 1955 1955 0 0
Breast
Cancer 1956 1956 0 0
Ovarian and primary peritoneal
Cancer 1957 1957 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Human Genetics and Inherited Disorders 1958 1958 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individual who are the first in their family to undertake mutation detection for a pathogenic mutation in either breast, ovarian or colorectal cancer and test positive are designated the proband. Probands are randomised to inform first and second degree relatives of their potential risk via either an active or passive method of disclosure. On the active disclosure arm, probands are encouraged to communicate directly with their relatives to inform them of their potential risk. In addition a Risk Notification Letter will be sent by the Familial Cancer Centre (FCC) to at risk relatives (ARR) informing them of the same. Probands randomised to the passive arm will be encouraged to inform their relatives of their potential risk but the FCC will not make contact with ARRs. Expected duration of recruitment and data capture phase of trial is 24 months.
Intervention code [1] 1807 0
Behaviour
Comparator / control treatment
Passive disclosure of genetic risk information to at risk relative according to ususal practice of Familial Cancer Centre. Probands are encouraged to inform ARR and they may be provided with a form letter but the FCC will not make contact with ARR.
Control group
Active

Outcomes
Primary outcome [1] 2773 0
The number of at-risk relatives who contact the FCC for further information
Timepoint [1] 2773 0
One year after randomisation
Secondary outcome [1] 4668 0
1. The number of at-risk relatives attending a FCC for a predictive genetic test.
Timepoint [1] 4668 0
One year after randomisation.
Secondary outcome [2] 4669 0
2. The number of at-risk relatives actively refusing further contact.
Timepoint [2] 4669 0
One year after randomisation.
Secondary outcome [3] 4670 0
3. The number of at risk relatives making a complaint.
Timepoint [3] 4670 0
One year after randomisation
Secondary outcome [4] 4671 0
4. The acceptability of the disclosure process to the proband.
Timepoint [4] 4671 0
6 weeks after randomisation.
Secondary outcome [5] 4672 0
5. The acceptability of the disclosure process to the at risk relative.
Timepoint [5] 4672 0
12-16 weeks after randomisation.
Secondary outcome [6] 4673 0
6. Estimation of any additional costs to the FCC associated with the active disclosure method.
Timepoint [6] 4673 0
One year after randomisation

Eligibility
Key inclusion criteria
1. A resident of Victoria
2. Current client of a Victorian Familial Cancer Centre
3. The first individual in the family to undertake mutation detection
4. Positive pathogenic mutation detected for breast/ovarian or colorectal cancer
5. Signed informed consent
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior disclosure of genetic test results
2. Other familal cancer syndromes eg, FAP (Familial Adenomatous Polyposis) or where predictive testing is used in childhood
3. Individuals with pre-existing psychiatric illness or cognitive disorder that would preclude informed consent
4. Individuals not fluent in written or spoken English language
5. Individuals in whom the consent for testing was gained by proxy
6. Another member of an affected family.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Stratification factors limited to Familial Cancer Centre
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/07/2007
Actual
11/12/2007
Date of last participant enrolment
Anticipated
Actual
12/12/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 2097 0
Government body
Name [1] 2097 0
Department of Human Services Victoria Public Health Research Project Grant
Country [1] 2097 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Cancer Council Victoria
Address
615 St Kilda Road
Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 1903 0
Hospital
Name [1] 1903 0
Royal Melbourne Hospital
Address [1] 1903 0
Familial Cancer Centre
c/o PO Royal Melbourne Hospital
Parkville Victoria 3050
Country [1] 1903 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3887 0
Royal Melbourne Hospital
Ethics committee address [1] 3887 0
PO Royal Melbourne Hospital
Parkville Victoria 3050
Ethics committee country [1] 3887 0
Australia
Date submitted for ethics approval [1] 3887 0
Approval date [1] 3887 0
15/11/2006
Ethics approval number [1] 3887 0
2006.107
Ethics committee name [2] 3888 0
Monash Medical Centre
Ethics committee address [2] 3888 0
Locked Bag 29
Clayton South Victoria 3169
Ethics committee country [2] 3888 0
Australia
Date submitted for ethics approval [2] 3888 0
Approval date [2] 3888 0
31/01/2007
Ethics approval number [2] 3888 0
06077A.
Ethics committee name [3] 3889 0
Peter MacCallum Cancer Care Centre
Ethics committee address [3] 3889 0
Ethics committee country [3] 3889 0
Australia
Date submitted for ethics approval [3] 3889 0
Approval date [3] 3889 0
13/07/2007
Ethics approval number [3] 3889 0
06/32
Ethics committee name [4] 6123 0
Barwon Health Human Research Ethics Committee
Ethics committee address [4] 6123 0
The Geelong Hospital
Ryrie Street P.O Box 281
Geelong Victoria 3220
Ethics committee country [4] 6123 0
Australia
Date submitted for ethics approval [4] 6123 0
Approval date [4] 6123 0
05/09/2008
Ethics approval number [4] 6123 0
08/87
Ethics committee name [5] 6792 0
Austin Health
Research Ethics Unit
Ethics committee address [5] 6792 0
Level 8 HSB - Room 8322
Austin Hospital 145 Studley Rd
Heidelberg 3084
Ethics committee country [5] 6792 0
Australia
Date submitted for ethics approval [5] 6792 0
Approval date [5] 6792 0
05/01/2009
Ethics approval number [5] 6792 0
H2009/03341

Summary
Brief summary
This study looks at the disclosure of information indicating a genetic risk of cancer.

Who is it for?
You can join this study if you attend a Victorian Familial Cancer Centre and you are the first person in your family to have a genetic (mutation) test for breast, ovarian or colorectal cancer and your test is positive (that is, you have a gene that predisposes you to cancer).

Trial details
Participants will be randomly divided into two groups. Participants in one group (the treatment group) will be encouraged to tell their relatives about the result of their genetic test, and a Risk Notification Letter will also be sent to their relatives from the Familial Cancer Centre. This process is called ‘active disclosure’.

Participants in the other group (the control group) will be encouraged to tell their relatives the result of their genetic test, but a letter will not be sent from the Familial Cancer Centre. This process is called ‘passive disclosure’.

The number of relatives from both groups who contact the Familial Cancer Centre during the next year will be recorded. The number of relatives who have genetic tests and the acceptability of the process to participants and their relatives will also be measured.

The aim of the study is to test whether active disclosure may be a more effective and acceptable way of providing information to people who may have a genetic predisposition to cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27910 0
Prof not applicable as trial terminated
Address 27910 0
not applicable as trial terminated
Country 27910 0
Australia
Phone 27910 0
not applicable as trial terminated
Fax 27910 0
Email 27910 0
not applicable as trial terminated
Contact person for public queries
Name 10996 0
Prof Clinical Trials Office
Address 10996 0
Cancer Council Victoria
615 St Kilda Road
Melbourne Victoria 3004
Country 10996 0
Australia
Phone 10996 0
+61 3 95146230
Fax 10996 0
+61 3 95146751
Email 10996 0
[email protected]
Contact person for scientific queries
Name 1924 0
Prof Professor Ingrid Winship
Address 1924 0
Department of Adult Clinical Genetics University of Melbourne
Royal Melbourne Hospital
Grattan Street
Parkville Victoria 3050
Country 1924 0
Australia
Phone 1924 0
+61 3 93427151
Fax 1924 0
+61 3 93424267
Email 1924 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.