BRCA1 Gene Mutation, BRCA2 Gene Mutation, Breast Cancer, Ovarian Cancer
Conditions
Keywords
Cancer, Breast cancer, Ovarian cancer, BRCA Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Telephone genetic counselling, Cancer prevention
Brief summary
This study aims to develop a follow-up telephone-based genetic counselling (FTGC) intervention for women with a BRCA1 or BRCA2 mutation who have received genetic counseling in the past. Typically, when women undergo genetic testing, they receive standard genetic counselling prior to testing in order to fully understand the procedure and associated implications. If a woman's genetic test results are positive for a mutation, cancer prevention options are then discussed with a counsellor. However, in Canada, there is currently no formal follow-up counselling for women with a BRCA mutation to provide ongoing guidance and support about latest risk reduction strategies. Standard care relies on women making contact for any follow-up questions or concerns they may have. As a result, these women might not have the most current information regarding genetic risk assessment and prevention options. Therefore, individuals are being asked to participate in this study to aid research about the efficacy of FTGC in women with a BRCA mutation.
Interventions
BEHAVIORALFollow-up Telephone Genetic Counselling
Individualized theoretical genetic counselling among women with BRCA mutations to assess the impact it has on the uptake of cancer prevention strategies.
Sponsors
Canadian Institutes of Health Research (CIHR)
London Health Sciences Centre
Princess Margaret Hospital, Canada
H. Lee Moffitt Cancer Center and Research Institute
Women's College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed BRCA mutation * Age 35 to 70 years * No previous bilateral salpingo-oophorectomy * No previous or current ovarian cancer * At least 12 months since genetic testing or most recent contact by Narod follow-up study * Can speak and understand English
Exclusion criteria
* Currently receiving treatment for another cancer diagnosis * Pregnant * Given birth in the last 6 months * Booked surgical date for BSO
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of FTGC session | 3 years | The primary aim is to determine the effects of a tailored risk communication intervention (FTGC) compared to a standard intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emotional and cognitive outcomes of intervention | 3 yrs | Secondary aims are to compare the two study groups with regard to intent of cancer prevention strategies, decisional conflict, cancer-related distress, cancer risk and prevention knowledge, choice predisposition and health service utilization. |
Countries
Canada
Contacts
Primary ContactSophia Virani
Outcome results
None listed