Cancer Prevention in Women With a BRCA Mutation

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Women's College Hospital
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation
London Health Sciences Centre
Montreal General Hospital
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
Women's College Hospital
ClinicalTrials.gov Identifier:
NCT02225015
First received: August 21, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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.


Condition Intervention
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Breast Cancer
Ovarian Cancer
Behavioral: Follow-up Telephone Genetic Counselling

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Women's College Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 500
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)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed BRCA mutations
  • Age 35 to 70 years
  • No previous BSO
  • No previous or current ovarian cancer
  • At least 12 months since genetic testing or most recent contact by Narod follow-up study
  • Have provided written consent to be re-contacted for future research
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02225015

Contacts
Contact: Sophia Virani 416-351-3800 ext 2761 sophia.virani@wchospital.ca

Locations
Canada, Ontario
Juravinski Cancer Centre Not yet recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Louise Bordeleau, Dr.    905-387-9711 ext 64609    louise.bordeleau@jcc.hhsc.ca   
London Regional Cancer Centre Not yet recruiting
London, Ontario, Canada, N6C 2R6
Contact: Peter Ainsworth, Dr.    519.685.8122 ext 58122    ainswort@uwo.ca   
Princess Margaret Hospital Not yet recruiting
Toronto, Ontario, Canada, M5T 2M9
Contact: Barry Rosen, Dr.    416 946 4501 ext 2137    barry.rosen@uhn.ca   
Women's College Hospital Not yet recruiting
Toronto, Ontario, Canada, M5S 1B1
Contact: Steven Narod, Dr.    416-351-3765    steven.narod@wchospital.ca   
Canada, Quebec
Montreal General Hospital Not yet recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: William Foulkes, Dr.    514-340-8222 ext 3213      
Sponsors and Collaborators
Women's College Hospital
Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation
London Health Sciences Centre
Montreal General Hospital
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Kelly Metcalfe, Dr. University of Toronto
  More Information

Additional Information:
Publications:
Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT02225015     History of Changes
Other Study ID Numbers: 324638
Study First Received: August 21, 2014
Last Updated: August 21, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Women's College Hospital:
Cancer
Breast cancer
Ovarian cancer
BRCA Mutation
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Prophylactic bilateral salpingo oophorectomy (BSO)
Telephone genetic counselling
Cancer prevention

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Breast Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014