None listed
Conditions
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.
Interventions
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
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.
Sponsors
The Cancer Council Victoria
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
A diagnosis of advanced/metastatic cancer
Outcome results
None listed