Cancer Prevention in Women With a BRCA Mutation

Study Overview
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Brief Summary
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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.

Official Title
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Cancer Prevention in Women With a BRCA Mutation: A Follow-up Genetic Counselling Intervention

Conditions
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BRCA1 Gene Mutation, BRCA2 Gene Mutation, Breast Cancer, Ovarian Cancer

Intervention / Treatment
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* Behavioral: Follow-up Telephone Genetic Counselling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FTGC at 1 month<br>Individuals randomized to the intervention group will receive a tailored cancer risk assessment via a follow-up telephone genetic counselling (FTGC) session within one month of study enrollment. | Behavioral: Follow-up Telephone Genetic Counselling<br>* Individualized theoretical genetic counselling among women with BRCA mutations to assess the impact it has on the uptake of cancer prevention strategies.<br>|
| No Intervention: Standard Care + FTGC in 12 months<br>Individuals randomized to the intervention group will receive a tailored cancer risk assessment at 12 months following study enrollment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of FTGC session | The primary aim is to determine the effects of a tailored risk communication intervention (FTGC) compared to a standard intervention | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional and cognitive outcomes of intervention | 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. | 3 yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Breast cancer, Ovarian cancer, BRCA Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Telephone genetic counselling, Cancer prevention