Clinical trial NCT02225015: Cancer Prevention in Women With a BRCA Mutation
Official title: Cancer Prevention in Women With a BRCA Mutation: A Follow-up Genetic Counselling Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: BRCA1 Gene Mutation
BRCA2 Gene Mutation
Breast Cancer
Ovarian Cancer
Keywords: Cancer
Breast cancer
Ovarian cancer
BRCA Mutation
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Telephone genetic counselling
Cancer prevention
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: London Health Sciences Centre
name: Princess Margaret Hospital, Canada
name: H. Lee Moffitt Cancer Center and Research Institute
First posted: 2014-08-25
Enrollment: 300
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of FTGC session
timeFrame: 3 years
Secondary outcomes:
measure: Emotional and cognitive outcomes of intervention
timeFrame: 3 yrs
Other outcomes:
Locations:
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Kelly Metcalfe, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. doi: 10.1056/NEJMoa012158. Epub 2002 May 20.