Cancer Prevention in Women With a BRCA Mutation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Women's College Hospital
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
London Health Sciences Centre
Princess Margaret Hospital, Canada
H. Lee Moffitt Cancer Center and Research Institute
Information provided by (Responsible Party):
Women's College Hospital
ClinicalTrials.gov Identifier:
NCT02225015
First received: August 21, 2014
Last updated: June 9, 2015
Last verified: June 2015
  Purpose

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.


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:
  • Efficacy of FTGC session [ 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


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 intent of cancer prevention strategies, 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: FTGC at 1 month
Individuals 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.
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.
No Intervention: Standard Care + FTGC in 12 months
Individuals randomized to the intervention group will receive a tailored cancer risk assessment at 12 months following study enrollment

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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
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 Recruiting
Toronto, Ontario, Canada, M5S 1B1
Contact: Steven Narod, Dr.    416-351-3765    steven.narod@wchospital.ca   
Sponsors and Collaborators
Women's College Hospital
Canadian Institutes of Health Research (CIHR)
London Health Sciences Centre
Princess Margaret Hospital, Canada
H. Lee Moffitt Cancer Center and Research Institute
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: June 9, 2015
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
Telephone genetic counselling
Cancer prevention

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

ClinicalTrials.gov processed this record on August 31, 2015