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Cancer Prevention in Women With a BRCA Mutation

This study is currently recruiting participants.
Verified June 2016 by Women's College Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02225015
First Posted: August 25, 2014
Last Update Posted: June 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
  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 Phase
BRCA1 Gene Mutation BRCA2 Gene Mutation Breast Cancer Ovarian Cancer Behavioral: Follow-up Telephone Genetic Counselling Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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: 3 years ]
    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: 3 yrs ]
    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: 300
Study Start Date: January 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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   
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S 1B1
Contact: Steven Narod, Dr.    416-351-3765    steven.narod@wchospital.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   
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
First Submitted: August 21, 2014
First Posted: August 25, 2014
Last Update Posted: June 9, 2016
Last Verified: June 2016

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
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders