Cancer Prevention in Women With a BRCA Mutation
In Canadian women with a BRCA mutation over the age of 35, it is recommended that a prophylactic bilateral salpingo-oophorectomy (BSO) be done to lower the risk of both breast and ovarian cancers. However, 45% of these high-risk women have not had a BSO. Low uptake of prophylactic BSO in this population may be the result of the current delivery of cancer genetics services in which there is no formal clinical follow-up with women after disclosure of genetic test results. There is recent evidence of the efficacy of follow-up telephone genetic counseling in increasing uptake of cancer screening, which could be expanded to risk reduction strategies including BSO. Therefore, a follow-up intervention, such as genetic counseling via telephone, is essential in order to increase the uptake of BSO in this population to ensure that women reduce their risk of developing and/or dying of BRCA related cancers.
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Behavioral: Follow-up Telephone Genetic Counselling
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Cancer Prevention in Women With a BRCA Mutation: A Follow-up Genetic Counselling Intervention|
- BSO uptake [ Time Frame: 12 months ] [ Designated as safety issue: No ]The primary aim is to determine the effects of a tailored risk communication intervention (FTGC) compared to a standard intervention in regards to prophylactic BSO.
- Emotional and cognitive outcomes of intervention [ Time Frame: 1 year ] [ Designated as safety issue: No ]Secondary aims are to compare the two study groups with regard to BSO intent, decisional conflict, cancer-related distress, cancer risk and prevention knowledge, choice predisposition and health service utilization.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Follow-up telephone genetic counselling
Individuals randomized to the intervention group will receive a tailored cancer risk assessment and behavior change counselling session conducted by board-certified genetic counsellors trained in behavioral theory and motivational interviewing.
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 the recommended prophylactic BSO procedure, which has been shown to greatly improve survival rates in this group of high-risk women.
No Intervention: Standard Care
Typically, a woman receives standard genetic counseling by a certified genetic counsellor at a regional cancer genetics clinic prior to genetic testing to ensure that she has a full understanding of the implications of testing. In addition, cancer prevention options (including surgery and chemoprevention) are discussed both prior to and after genetic testing. At the genetic testing disclosure session, a woman is given her genetic test results and cancer prevention options are discussed. However, there is currently no formal cancer genetics follow-up with women with a BRCA mutation to provide ongoing guidance and support related to cancer risk reduction.
Research Questions: Among women with a BRCA mutation, over the age of 35 years who have not had a BSO, what is the effect of a follow-up telephone-based genetic counselling (FTGC) intervention on the uptake (completed or scheduled) of prophylactic BSO at 12 months post-randomization? In addition, what is the effect of the intervention on decisional conflict, cancer-related distress, knowledge related to BRCA and cancer risk reduction, choice predisposition related to BSO, intent to undergo BSO within the next year, and health service utilization from enrolment to 12 months post-randomization?
Methodology: The design will be a randomized controlled trial. All women in the Narod database who meet eligibility criteria from the participating cancer genetics clinics will be identified. These women have already provided written consent to be contacted for future research. The study coordinator will contact each woman and provide a detailed study explanation, assess for eligibility, and obtain written consent. Using questions included in the Self-Assessed Literacy Index, the coordinator will assess language eligibility. Following the collection of baseline data, all eligible, consenting women will be randomly allocated to either the intervention group (follow-up telephone genetic counselling (FTGC) intervention) or the control group (standard care). Participants in the control group will receive standard care. Participants allocated to the intervention group will receive standard care plus the FTGC intervention, which includes an individualized theoretically based genetic counselling session and referral to a gynaecological surgeon. A research assistant blinded to group allocation will telephone all participants at 12 months post-randomization to collect outcome data. After completion of follow-up questionnaires, women in the control group will be offered the follow-up telephone genetic counselling session.
Significance: Genetic testing for BRCA1 and BRCA2 allows for the identification of women with one of the highest known risks for breast and ovarian cancer. BSO significantly reduces these cancer risks, and is the only known intervention to significantly reduce mortality in these high-risk women, and as a result, BSO is recommended to all women with a BRCA mutation at the age of 35 years. However, not all women elect for this procedure. An intervention is needed to increase uptake of BSO in this high-risk population. This study will allow for the translation of research findings on cancer prevention
Please refer to this study by its ClinicalTrials.gov identifier: NCT02225015
|Contact: Sophia Virani||416-351-3800 ext firstname.lastname@example.org|
|Juravinski Cancer Centre||Not yet recruiting|
|Hamilton, Ontario, Canada, L8V 5C2|
|Contact: Louise Bordeleau, Dr. 905-387-9711 ext 64609 email@example.com|
|London Regional Cancer Centre||Not yet recruiting|
|London, Ontario, Canada, N6C 2R6|
|Contact: Peter Ainsworth, Dr. 519.685.8122 ext 58122 firstname.lastname@example.org|
|Princess Margaret Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5T 2M9|
|Contact: Barry Rosen, Dr. 416 946 4501 ext 2137 email@example.com|
|Women's College Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5S 1B1|
|Contact: Steven Narod, Dr. 416-351-3765 firstname.lastname@example.org|
|Montreal General Hospital||Not yet recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Contact: William Foulkes, Dr. 514-340-8222 ext 3213|
|Principal Investigator:||Kelly Metcalfe, Dr.||University of Toronto|