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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.

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

Secondary ID [1]

New secondary ID. Please modify.

Universal Trial Number (UTN)

Trial acronym

GIF Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Inherited conditions

Chromosomal translocations

Condition category

Condition code

Human Genetics and Inherited Disorders

Cystic fibrosis

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Intervention/exposure

Study type

Interventional

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.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Prevention

Intervention code [3]

Behaviour

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.

Control group

Active

Outcomes

Primary outcome [1]

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.

Timepoint [1]

12 months after inclusion into the trial.

Secondary outcome [1]

Participant self-report of the number of family members informed about genetic information

Timepoint [1]

12 months after inclusion in the trial.

Secondary outcome [2]

Process evaluation including qualitative analysis of the experiences of participants and intervention providers

Timepoint [2]

12 months after inclusion in the trial.

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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

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

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)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/02/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

140

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

3052

Recruitment postcode(s) [2]

3168

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NH&MRC)

Address [1]

GPO Box 1421
Canberra
ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

A/Prof Jane Halliday

Address

Public Health Genetics
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Rd
Parkville, Victoria 3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health

Ethics committee address [1]

PO Royal Melbourne Hospital
Parkville
Victoria 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/07/2008

Ethics approval number [1]

2008.068

Ethics committee name [2]

Southern Health

Ethics committee address [2]

246 Clayton Rd
Clayton
Victoria 3168

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

29/07/2008

Ethics approval number [2]

08095B

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Jan Hodgson

Address

Genetics Education and Health Research
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Rd
Parkville, Victoria 3052

Country

Australia

Phone

+61 3 8341 6308

Fax

+61 3 8341 6212

[email protected]

Contact person for scientific queries

Name

A/Prof Jane Halliday

Address

Public Health Genetics
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Rd
Parkville, Victoria 3052

Country

Australia

Phone

+61 3 8341 6260

Fax

+61 3 8341 6212

[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

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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