Trial Review

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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 information initially 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] 638 0
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 3437 0
Condition category
Condition code
Cancer 3566 3566 0 0
Ovarian and primary peritoneal
Mental Health 3567 3567 0 0
Anxiety
Cancer 3591 3591 0 0
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] 3143 0
Behaviour
Intervention code [2] 3170 0
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] 4493 0
Distress measured by the Impact of Events Scale
Timepoint [1] 4493 0
Baseline, then at 4-months and 6-months post-randomisation
Secondary outcome [1] 7601 0
Social isolation, measured by a modified version of the UCLA Loneliness Scale
Timepoint [1] 7601 0
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] 1013 0
2000-2999

Funding & Sponsors
Funding source category [1] 3620 0
Charities/Societies/Foundations
Name [1] 3620 0
National Breast Cancer Foundation
Country [1] 3620 0
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] 3255 0
None
Name [1] 3255 0
Address [1] 3255 0
Country [1] 3255 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5672 0
The Cancer Council Victoria Human Research Ethics Committee
Ethics committee address [1] 5672 0
1 Rathdowne Street, Carlton, VIC, 3053.
Ethics committee country [1] 5672 0
Australia
Date submitted for ethics approval [1] 5672 0
Approval date [1] 5672 0
15/07/2008
Ethics approval number [1] 5672 0
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 28755 0
Dr Victoria White
Address 28755 0
615 st Kilda Rd
Melbourne
Country 28755 0
Australia
Phone 28755 0
03 9514 6352
Fax 28755 0
Email 28755 0
Victoria White
Contact person for public queries
Name 11912 0
Dr Victoria White
Address 11912 0
Deputy Director, Centre for Behavioural Research in Cancer, The Cancer Council Victoria, 1 Rathdowne Street, Carlton, VIC, 3053.
Country 11912 0
Australia
Phone 11912 0
+61
Fax 11912 0
(03) 9635 5380
Email 11912 0
Vicki.White@cancervic.org.au
Contact person for scientific queries
Name 2840 0
Dr Victoria White
Address 2840 0
Deputy Director, Centre for Behavioural Research in Cancer, The Cancer Council Victoria, 1 Rathdowne Street, Carlton, VIC, 3053.
Country 2840 0
Australia
Phone 2840 0
+61
Fax 2840 0
(03) 9635 5380
Email 2840 0
Vicki.White@cancervic.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes White VM, Young MA, Farrelly A, Meiser B, Jefford ... [More Details]
Study results articleYes Farrelly A, White V, Young MA, Jefford M, Ieropoli... [More Details]

Documents added automatically
No additional documents have been identified.