Cancer Prevention in Women With a BRCA Mutation

June 7, 2016 updated by: Women's College Hospital

Cancer Prevention in Women With a BRCA Mutation: A Follow-up Genetic Counselling Intervention

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 2R6
        • Not yet recruiting
        • London Regional Cancer Centre
        • Contact:
          • Peter Ainsworth, Dr.
          • Phone Number: 58122 519.685.8122
          • Email: ainswort@uwo.ca
      • Toronto, Ontario, Canada, M5S 1B1
      • Toronto, Ontario, Canada, M5T 2M9
        • Not yet recruiting
        • Princess Margaret Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's College Hospital

Collaborators

Canadian Institutes of Health Research (CIHR)
London Health Sciences Centre
H. Lee Moffitt Cancer Center and Research Institute
Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Kelly Metcalfe, Dr., University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (ESTIMATE)

August 25, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 324638

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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