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Trial registered on ANZCTR
Registration number
ACTRN12608000642381
Ethics application status
Approved
Date submitted
13/10/2008
Date registered
17/12/2008
Date last updated
4/07/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Communication of genetic information in families: A randomised trial of a genetic counselling intervention.
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Scientific title
In individuals where there has been a new diagnosis of a genetic condition that has implications for family members, does enhanced genetic counselling compared with usual genetic counselling increase attendance at genetics services by their family members within 18 months of inclusion in the trial
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Secondary ID [1]
262763
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New secondary ID. Please modify.
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Universal Trial Number (UTN)
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Trial acronym
GIF Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Inherited conditions
3908
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Chromosomal translocations
3909
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Condition category
Condition code
Human Genetics and Inherited Disorders
4005
4005
0
0
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Cystic fibrosis
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Human Genetics and Inherited Disorders
4006
4006
0
0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Telephone genetic counselling at 3, 6 and 9 months after inclusion in the trial in addition to usual care. Genetic counsellors will phone patients who satisfy inclusion criteria to address issues around family communication of genetic information. Anticipated duration of phone call is 15-20 minutes.
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Intervention code [1]
3541
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Early detection / Screening
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Intervention code [2]
3542
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Prevention
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Intervention code [3]
3543
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Behaviour
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Comparator / control treatment
The control group will receive usual care which involves the current practice of discussing the implications of the genetic information for family members, identifying relatives who might be at risk and offering a letter for the individual to give to family members, if that would be helpful. Usual practice is to see the patient at the time of diagnosis and give appropriate follow up. Usual care may vary from approximately 3-18 months depending on the particular condition and needs of the patient.
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Control group
Active
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Outcomes
Primary outcome [1]
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Proportion of family members accessing genetics services for either genetic counselling and/or genetic testing. Genetic files and laboratory records will be audited to determine if family members have accessed genetic services.
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Assessment method [1]
4907
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Timepoint [1]
4907
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12 months after inclusion into the trial.
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Secondary outcome [1]
8287
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Participant self-report of the number of family members informed about genetic information
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Assessment method [1]
8287
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Timepoint [1]
8287
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12 months after inclusion in the trial.
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Secondary outcome [2]
8288
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Process evaluation including qualitative analysis of the experiences of participants and intervention providers
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Assessment method [2]
8288
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Timepoint [2]
8288
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12 months after inclusion in the trial.
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Eligibility
Key inclusion criteria
1. Individuals or parents of children who are the first in a family to receive a diagnosis of a genetic condition that has implications for family members.
2. Have at least one at-risk relative living in Victoria.
3. Able to speak, read and write English
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. History of psychiatric illness or cognitive disorder that may affect ability to provide informed consent
2. A diagnosis during pregnancy
3. Overseas or interstate patients
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/02/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
140
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
1198
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3052
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Recruitment postcode(s) [2]
1199
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3168
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Funding & Sponsors
Funding source category [1]
4002
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Government body
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Name [1]
4002
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National Health and Medical Research Council (NH&MRC)
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Address [1]
4002
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GPO Box 1421
Canberra
ACT 2601
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Country [1]
4002
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Australia
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Primary sponsor type
Individual
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Name
A/Prof Jane Halliday
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Address
Public Health Genetics
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Rd
Parkville, Victoria 3052
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Country
Australia
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Secondary sponsor category [1]
3595
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None
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Name [1]
3595
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Address [1]
3595
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Country [1]
3595
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
6079
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Melbourne Health
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Ethics committee address [1]
6079
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PO Royal Melbourne Hospital
Parkville
Victoria 3050
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Ethics committee country [1]
6079
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Australia
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Date submitted for ethics approval [1]
6079
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Approval date [1]
6079
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16/07/2008
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Ethics approval number [1]
6079
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2008.068
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Ethics committee name [2]
6080
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Southern Health
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Ethics committee address [2]
6080
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246 Clayton Rd
Clayton
Victoria 3168
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Ethics committee country [2]
6080
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Australia
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Date submitted for ethics approval [2]
6080
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Approval date [2]
6080
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29/07/2008
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Ethics approval number [2]
6080
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08095B
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Summary
Brief summary
Advances in genetics research, including the Human Genome Project, have led to the availability of an increasing number of genetic tests that can give people information about their risk of developing specific genetic conditions. Genetic information given to an individual when diagnosed with a genetic condition is likely to have important health implications for their family members as well as themselves. However, the task of talking to family members about genetic information and what it means for family members can be difficult. Research has shown that commonly genetic information does not get passed on to all relevant family members and that this process is influenced by factors such as family dynamics and the complexity of the information. Despite this, current practice in genetic counselling, in keeping with Privacy laws, is for health care providers to discuss with patients attending genetic testing services the implications of their genetic information for their relatives, and the importance of the patient relaying that information to family members who have been identified as potentially at risk. Letters or information sheets for family members may be offered to the patient if they believe it would be helpful. There is much discussion about ways to improve communication of genetic information in families but very little evidence to guide practice. This study aims to evaluate a specific genetic counselling intervention to aid communication, using a robust randomised study design. Participants will be recruited from genetics clinics at several sites. Individuals who are presenting for the first time at a genetics clinic for the diagnosis of a genetic condition in themselves or their children, that has implications for family members, will be eligible to participate. They will also need to have at least one living relative who could benefit from being told the genetic information. Once participants are recruited into the study they will be randomly assigned to one of two groups. The control group will receive usual care which involves the current practice of discussing the implications of the genetic information for family members, identifying relatives who might be at risk and offering a letter for the individual to give to family members, if that would be helpful. The intervention group will receive an enhanced genetic counselling intervention where a research genetic counsellor will contact the person by phone at 3, 6 and 9 month intervals. The intervention comprises 15-20 minute telephone genetic counselling addressing family communication of genetic information. The effectiveness of the intervention will be assessed 18 months after enrolment into the study. Participants from both groups will be asked to complete a survey and the number of at-risk relatives who have attended a genetics service and/or had a genetic test will be ascertained from genetic health records. This is the first ever scientifically robust study to test an intervention to aid family communication of genetic information. It will provide evidence to guide genetic counselling practice in this important area of family communication.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
29031
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Country
29031
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Phone
29031
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Fax
29031
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Email
29031
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Contact person for public queries
Name
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Dr Jan Hodgson
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Address
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Genetics Education and Health Research
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Rd
Parkville, Victoria 3052
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Country
12188
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Australia
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Phone
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+61 3 8341 6308
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Fax
12188
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+61 3 8341 6212
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Email
12188
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Jane Halliday
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Address
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Public Health Genetics
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Rd
Parkville, Victoria 3052
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Country
3116
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Australia
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Phone
3116
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+61 3 8341 6260
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Fax
3116
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+61 3 8341 6212
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Email
3116
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Improving family communication after a new genetic diagnosis: A randomised controlled trial of a genetic counselling intervention.
2014
https://dx.doi.org/10.1186/1471-2350-15-33
N.B. These documents automatically identified may not have been verified by the study sponsor.
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