ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12608000343303

Ethics application status

Approved

Date submitted

15/07/2008

Date registered

22/07/2008

Date last updated

12/11/2018

Date data sharing statement initially provided

12/11/2018

Date results provided

12/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Can a peer support program for women with an altered cancer gene reduce distress?

Scientific title

In women identified as carrying the BRCA1/2 gene fault: Is a telephone-based peer support program as good or better than usual care for reduction of psychological distress?

Secondary ID [1]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Psychosocial effects of testing positive for a mutation of the BRCA1/2 gene

Condition category

Condition code

Cancer

Ovarian and primary peritoneal

Mental Health

Anxiety

Cancer

Breast

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Telephone-based peer support delivered by trained volunteers over a 4-month period. In the first instance, peer support volunteers will contact women receiving the peer support. Subsequent contacts may be initiated by either the recipient or peer support volunteer, but there is a minimum requirement of at least 6 telephone contacts over the 6-month period. The duration of sessions will be determined by the number of issues the support recipient wishes to discuss at that time. Peer volunteers will provide information and emotional support. One of their main roles will be to normalise the responses and experiences of support recipients. Peer support volunteers will be provided with a manual to help them provide information on the main issues surrounding a positive test for the BRCA1/2 gene fault, including: discussing genetic risk with family members; communicating with children about their potential risk and need for genetic testing; feelings of anxiety/depression; feelings of guilt about passing the risk on to children; sense of social isolation; risk management strategies such as mammograms, ultrasounds, MRI, CA125 measurement; implications of surgical management of risk e.g. mastectomy, oophorectomy, such as body image and fertility issues. Other topics such as privacy issues surrounding the collection of genetic material during testing, as well as insurance and work place discrimination issues.

Intervention code [1]

Behaviour

Intervention code [2]

Other interventions

Comparator / control treatment

Usual care (no peer support). The usual care group will be advised of the telephone number for the helpline operated by the Cancer Information and Support Service at The Cancer Council in their state and will be advised to call this service if they want to discuss any issues or find out about services that might be available to them.

Control group

Active

Outcomes

Primary outcome [1]

Distress measured by the Impact of Events Scale

Timepoint [1]

Baseline, then at 4-months and 6-months post-randomisation

Secondary outcome [1]

Social isolation, measured by a modified version of the UCLA Loneliness Scale

Timepoint [1]

Baseline, then at 4-months and 6-months post-randomisation

Eligibility

Key inclusion criteria

Women testing positive for the BRCA1/2 gene fault between 2004 and 2011. Women may participate if they have had a diagnosis of cancer.

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

A diagnosis of advanced/metastatic cancer

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)

Women who indicate on the baseline survey that they have an unmet need for information and support will be randomised to either the usual care or intervention group. As it is likely that more than one member of a family will be invited to take part in the study (e.g. mother/daughter, or siblings), a cluster randomisation method will be used based on family membership. The first member of a family to enter the study will be allocated to either the intervention or usual care groups using computerised sequence generation. Any members of the same family that subsequently enter the study will then be allocated to the same study group as the first family member. This is necessary to prevent contamination between the intervention and usual care groups within family clusters. Allocation will be concealed using central randomisation by computer.

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

Simple randomisation using computerised sequence generation.

Masking / blinding

Open (masking not 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

Completed

Date of first participant enrolment

Anticipated

1/08/2008

Actual

1/08/2008

Date of last participant enrolment

Anticipated

Actual

6/06/2013

Date of last data collection

Anticipated

Actual

30/09/2013

Sample size

Target

400

Accrual to date

Final

337

Recruitment in Australia

Recruitment state(s)

NSW,SA,VIC

Recruitment postcode(s) [1]

2000-2999

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

National Breast Cancer Foundation

Address [1]

Level 3, 18-20 York Street, Sydney, NSW, 2000

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

The Cancer Council Victoria

Address

1 Rathdowne Street, Carlton, VIC, 3053

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Cancer Council Victoria Human Research Ethics Committee

Ethics committee address [1]

1 Rathdowne Street, Carlton, VIC, 3053.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/07/2008

Ethics approval number [1]

HREC 0807

Summary

Brief summary

Women identified as carrying a gene fault that increases their risk of developing breast or ovarian cancer (BRCA1/2) live with the fear that they are likely to develop these cancers.  They also experience feelings of guilt about passing the gene onto their children, anxiety over informing family members, and grief.  Research has found that BRCA1/2 gene fault carriers experience similar levels of distress to breast cancer patients within a year of their diagnosis and that distress among carriers does not decrease with time. Currently in Australia formal support services for cancer gene mutation carriers outside the Familial Cancer Centres (FCCs) are lacking. The NHMRC’s, “Familial aspects of cancer: a guide to clinical practice” calls for research to identify effective intervention strategies to reduce morbidity associated with genetic testing.  BRCA1/2 gene fault carriers have an unmet need for support, and for help in reducing their sense of isolation, guilt, fear of the future and concerns about communicating test results with family members. 

We propose to address these unmet needs with a peer support program for women identified as carrying the BRCA1/2 gene fault  and examine whether this intervention can reduce psychological distress. 

The project’s aims are:

1.	To determine the effectiveness of a telephone based peer support program for women with a BRCA1/2 gene fault on psychological distress using a randomised controlled trial. 
2. 	To determine how feelings of isolation, unmet needs for information and confidence in risk management decisions relate to psychological distress and how these factors are influenced by the intervention. 
3.	To explore the impact of providing support among support providers. 

The design will be a prospective randomised controlled trial with female BRCA1/2 gene fault carriers.  Participants will be recruited through Familial Cancer Centres in Victoria and NSW.  Participants will complete a baseline survey that will allow the identification of those with unmet support needs.  This group will then be randomised to receive either the intervention (peer support program) or usual care.  Women in the intervention group will be assigned a peer support provider and will have telephone contact with the peer at least 6 times over a 4-month period.  Women who report no unmet needs for support at baseline will remain in the study and provide useful information about issues affecting people with this genetic mutation.  All participants will complete follow-up questionnaires at 4-months and 6-months post study entry.  Women who indicate on the baseline survey that they have no unmet needs for information and support will remain in the study and follow the same procedure as the usual care group.

Trial website

N/A

Trial related presentations / publications

the trial is finished and main results have now been reported in 

White VM, Young MA, Farrelly A, Meiser B, Jefford M, Williamson E, Ieropoli S, Duffy J, Winship I.
Randomized controlled trial of a telephone-based peer-support program for women carrying a BRCA1 or BRCA2 mutation: impact on psychological distress.

J Clin Oncol. 2014 Dec 20;32(36):4073-80

Public notes

Contacts

Principal investigator

Name

Dr Victoria White

Address

615 st Kilda Rd
Melbourne

Country

Australia

Phone

03 9514 6352

Fax

Victoria White

Contact person for public queries

Name

Dr Victoria White

Address

Deputy Director, Centre for Behavioural Research in Cancer, The Cancer Council Victoria, 1 Rathdowne Street, Carlton, VIC, 3053.

Country

Australia

Phone

+61

Fax

(03) 9635 5380

Vicki.White@cancervic.org.au

Contact person for scientific queries

Name

Dr Victoria White

Address

Deputy Director, Centre for Behavioural Research in Cancer, The Cancer Council Victoria, 1 Rathdowne Street, Carlton, VIC, 3053.

Country

Australia

Phone

+61

Fax

(03) 9635 5380

Vicki.White@cancervic.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

data is confidential and we do not have participant permission or ethics approval to share data

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.

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