Cancer Prevention in Women With a BRCA Mutation
1 other identifier
interventional
300
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2015
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2014
CompletedFirst Posted
Study publicly available on registry
August 25, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJune 9, 2016
June 1, 2016
3.4 years
August 21, 2014
June 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Emotional and cognitive outcomes of intervention
3 yrs
Study Arms (2)
FTGC at 1 month
ACTIVE COMPARATORIndividuals 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.
Standard Care + FTGC in 12 months
NO INTERVENTIONIndividuals randomized to the intervention group will receive a tailored cancer risk assessment at 12 months following study enrollment
Interventions
Individualized theoretical genetic counselling among women with BRCA mutations to assess the impact it has on the uptake of cancer prevention strategies.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Currently receiving treatment for another cancer diagnosis
- Pregnant
- Given birth in the last 6 months
- Booked surgical date for BSO
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Women's College Hospitallead
- Canadian Institutes of Health Research (CIHR)collaborator
- London Health Sciences Centrecollaborator
- Princess Margaret Hospital, Canadacollaborator
- H. Lee Moffitt Cancer Center and Research Institutecollaborator
Study Sites (3)
London Regional Cancer Centre
London, Ontario, N6C 2R6, Canada
Women's College Hospital
Toronto, Ontario, M5S 1B1, Canada
Princess Margaret Hospital
Toronto, Ontario, M5T 2M9, Canada
Related Publications (3)
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.
PMID: 24449229BACKGROUNDKauff 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.
PMID: 18268356BACKGROUNDRebbeck 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. doi: 10.1056/NEJMoa012158. Epub 2002 May 20.
PMID: 12023993BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly Metcalfe, Dr.
University of Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2014
First Posted
August 25, 2014
Study Start
January 1, 2015
Primary Completion
June 1, 2018
Study Completion
June 1, 2019
Last Updated
June 9, 2016
Record last verified: 2016-06