Cancer Prevention in Women With a BRCA Mutation

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02225015
• Other study ID #: 324638
• Status: Recruiting
• Phase: Phase 1
• First received: August 21, 2014
• Last updated: June 7, 2016
• Start date: January 2015
• Est. completion date: June 2019

Study information

• Verified date: June 2016
• Source: Women's College Hospital
• Contact: Sophia Virani
• Phone: 416-351-3800
• Email: sophia.virani[@]wchospital.ca
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• BRCA1 Gene Mutation
• BRCA2 Gene Mutation
• Breast Cancer
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Follow-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.

Locations

Country	Name	City	State
Canada	London Regional Cancer Centre	London	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Women's College Hospital	Canadian Institutes of Health Research (CIHR), H. Lee Moffitt Cancer Center and Research Institute, London Health Sciences Centre, Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Kauff ND, Domchek SM, Friebel TM, Robson ME, Lee J, Garber JE, Isaacs C, Evans DG, Lynch H, Eeles RA, Neuhausen SL, Daly MB, Matloff E, Blum JL, Sabbatini P, Barakat RR, Hudis C, Norton L, Offit K, Rebbeck TR. Risk-reducing salpingo-oophorectomy for the prevention of BRCA1- and BRCA2-associated breast and gynecologic cancer: a multicenter, prospective study. J Clin Oncol. 2008 Mar 10;26(8):1331-7. doi: 10.1200/JCO.2007.13.9626. Epub 2008 Feb 11. — View Citation

Kinney AY, Boonyasiriwat W, Walters ST, Pappas LM, Stroup AM, Schwartz MD, Edwards SL, Rogers A, Kohlmann WK, Boucher KM, Vernon SW, Simmons RG, Lowery JT, Flores K, Wiggins CL, Hill DA, Burt RW, Williams MS, Higginbotham JC. Telehealth personalized cancer risk communication to motivate colonoscopy in relatives of patients with colorectal cancer: the family CARE Randomized controlled trial. J Clin Oncol. 2014 Mar 1;32(7):654-62. doi: 10.1200/JCO.2013.51.6765. Epub 2014 Jan 21. — View Citation

Rebbeck TR, Lynch HT, Neuhausen SL, Narod SA, Van't Veer L, Garber JE, Evans G, Isaacs C, Daly MB, Matloff E, Olopade OI, Weber BL; Prevention and Observation of Surgical End Points Study Group. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. N Engl J Med. 2002 May 23;346(21):1616-22. Epub 2002 May 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   NCCN Guidelines for Detection, Prevention, & Risk Reduction