Cancer Prevention in Women With a BRCA Mutation

Phase 1

• Conditions: BRCA1 Gene Mutation; Breast Cancer; Ovarian Cancer; BRCA2 Gene Mutation
• Interventions: Behavioral: Follow-up Telephone Genetic Counselling

• Registration Number: NCT02225015
• Lead Sponsor: Women's College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-25
• Study Start: 2015-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-07
• Last Update Posted: 2016-06-09
• Primary Completion: 2018-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FTGC at 1 month	Follow-up Telephone Genetic Counselling	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

London Regional Cancer Centre; 🇨🇦 London, Ontario, Canada

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada