Cancer Prevention in Women With a BRCA Mutation

Women's College Hospital

Status and phase: Unknown; Phase 1

Conditions: Breast Cancer; BRCA2 Gene Mutation; Ovarian Cancer; BRCA1 Gene Mutation

Treatments: Behavioral: Follow-up Telephone Genetic Counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT02225015

324638

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

FTGC at 1 month

Active Comparator group

Description:

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.

Treatment:

Behavioral: Follow-up Telephone Genetic Counselling

Standard Care + FTGC in 12 months

No Intervention group

Description:

Individuals randomized to the intervention group will receive a tailored cancer risk assessment at 12 months following study enrollment