<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02225015</url>
  </required_header>
  <id_info>
    <org_study_id>324638</org_study_id>
    <nct_id>NCT02225015</nct_id>
  </id_info>
  <brief_title>Cancer Prevention in Women With a BRCA Mutation</brief_title>
  <official_title>Cancer Prevention in Women With a BRCA Mutation: A Follow-up Genetic Counselling Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Women's College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>London Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Princess Margaret Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Women's College Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to develop a follow-up telephone-based genetic counselling (FTGC)&#xD;
      intervention for women with a BRCA1 or BRCA2 mutation who have received genetic counseling in&#xD;
      the past. Typically, when women undergo genetic testing, they receive standard genetic&#xD;
      counselling prior to testing in order to fully understand the procedure and associated&#xD;
      implications. If a woman's genetic test results are positive for a mutation, cancer&#xD;
      prevention options are then discussed with a counsellor. However, in Canada, there is&#xD;
      currently no formal follow-up counselling for women with a BRCA mutation to provide ongoing&#xD;
      guidance and support about latest risk reduction strategies. Standard care relies on women&#xD;
      making contact for any follow-up questions or concerns they may have. As a result, these&#xD;
      women might not have the most current information regarding genetic risk assessment and&#xD;
      prevention options. Therefore, individuals are being asked to participate in this study to&#xD;
      aid research about the efficacy of FTGC in women with a BRCA mutation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of FTGC session</measure>
    <time_frame>3 years</time_frame>
    <description>The primary aim is to determine the effects of a tailored risk communication intervention (FTGC) compared to a standard intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emotional and cognitive outcomes of intervention</measure>
    <time_frame>3 yrs</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>BRCA1 Gene Mutation</condition>
  <condition>BRCA2 Gene Mutation</condition>
  <condition>Breast Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>FTGC at 1 month</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care + FTGC in 12 months</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals randomized to the intervention group will receive a tailored cancer risk assessment at 12 months following study enrollment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Follow-up Telephone Genetic Counselling</intervention_name>
    <description>Individualized theoretical genetic counselling among women with BRCA mutations to assess the impact it has on the uptake of cancer prevention strategies.</description>
    <arm_group_label>FTGC at 1 month</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed BRCA mutation&#xD;
&#xD;
          -  Age 35 to 70 years&#xD;
&#xD;
          -  No previous bilateral salpingo-oophorectomy&#xD;
&#xD;
          -  No previous or current ovarian cancer&#xD;
&#xD;
          -  At least 12 months since genetic testing or most recent contact by Narod follow-up&#xD;
             study&#xD;
&#xD;
          -  Can speak and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently receiving treatment for another cancer diagnosis&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Given birth in the last 6 months&#xD;
&#xD;
          -  Booked surgical date for BSO&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly Metcalfe, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sophia Virani</last_name>
    <phone>416-351-3800</phone>
    <phone_ext>2761</phone_ext>
    <email>sophia.virani@wchospital.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>London Regional Cancer Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6C 2R6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Peter Ainsworth, Dr.</last_name>
      <phone>519.685.8122</phone>
      <phone_ext>58122</phone_ext>
      <email>ainswort@uwo.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Women's College Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 1B1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Narod, Dr.</last_name>
      <phone>416-351-3765</phone>
      <email>steven.narod@wchospital.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Barry Rosen, Dr.</last_name>
      <phone>416 946 4501</phone>
      <phone_ext>2137</phone_ext>
      <email>barry.rosen@uhn.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.nccn.org/professionals/physician_gls/f_guidelines.asp</url>
    <description>NCCN Guidelines for Detection, Prevention, &amp; Risk Reduction</description>
  </link>
  <reference>
    <citation>Kinney AY, Boonyasiriwat W, Walters ST, Pappas LM, Stroup AM, Schwartz MD, Edwards SL, Rogers A, Kohlmann WK, Boucher KM, Vernon SW, Simmons RG, Lowery JT, Flores K, Wiggins CL, Hill DA, Burt RW, Williams MS, Higginbotham JC. Telehealth personalized cancer risk communication to motivate colonoscopy in relatives of patients with colorectal cancer: the family CARE Randomized controlled trial. J Clin Oncol. 2014 Mar 1;32(7):654-62. doi: 10.1200/JCO.2013.51.6765. Epub 2014 Jan 21.</citation>
    <PMID>24449229</PMID>
  </reference>
  <reference>
    <citation>Kauff ND, Domchek SM, Friebel TM, Robson ME, Lee J, Garber JE, Isaacs C, Evans DG, Lynch H, Eeles RA, Neuhausen SL, Daly MB, Matloff E, Blum JL, Sabbatini P, Barakat RR, Hudis C, Norton L, Offit K, Rebbeck TR. Risk-reducing salpingo-oophorectomy for the prevention of BRCA1- and BRCA2-associated breast and gynecologic cancer: a multicenter, prospective study. J Clin Oncol. 2008 Mar 10;26(8):1331-7. doi: 10.1200/JCO.2007.13.9626. Epub 2008 Feb 11.</citation>
    <PMID>18268356</PMID>
  </reference>
  <reference>
    <citation>Rebbeck TR, Lynch HT, Neuhausen SL, Narod SA, Van't Veer L, Garber JE, Evans G, Isaacs C, Daly MB, Matloff E, Olopade OI, Weber BL; Prevention and Observation of Surgical End Points Study Group. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. N Engl J Med. 2002 May 23;346(21):1616-22. doi: 10.1056/NEJMoa012158. Epub 2002 May 20.</citation>
    <PMID>12023993</PMID>
  </reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>June 7, 2016</last_update_submitted>
  <last_update_submitted_qc>June 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Breast cancer</keyword>
  <keyword>Ovarian cancer</keyword>
  <keyword>BRCA Mutation</keyword>
  <keyword>BRCA1 Gene Mutation</keyword>
  <keyword>BRCA2 Gene Mutation</keyword>
  <keyword>Telephone genetic counselling</keyword>
  <keyword>Cancer prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02225015
org study id: 324638
nct id: NCT02225015
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Efficacy of FTGC session
time frame: 3 years
description: The primary aim is to determine the effects of a tailored risk communication intervention (FTGC) compared to a standard intervention
measure: Emotional and cognitive outcomes of intervention
time frame: 3 yrs
description: 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.
arm group label: FTGC at 1 month
arm group type: Active Comparator
description: 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.
arm group label: Standard Care + FTGC in 12 months
arm group type: No Intervention
description: Individuals randomized to the intervention group will receive a tailored cancer risk assessment at 12 months following study enrollment
intervention type: Behavioral
intervention name: Follow-up Telephone Genetic Counselling
description: Individualized theoretical genetic counselling among women with BRCA mutations to assess the impact it has on the uptake of cancer prevention strategies.
arm group label: FTGC at 1 month
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kelly Metcalfe, Dr.
role: Principal Investigator
affiliation: University of Toronto
last name: Sophia Virani
phone: 416-351-3800
phone ext: 2761
email: sophia.virani@wchospital.ca
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Canada
url: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp
description: NCCN Guidelines for Detection, Prevention, & Risk Reduction
citation: Kinney AY, Boonyasiriwat W, Walters ST, Pappas LM, Stroup AM, Schwartz MD, Edwards SL, Rogers A, Kohlmann WK, Boucher KM, Vernon SW, Simmons RG, Lowery JT, Flores K, Wiggins CL, Hill DA, Burt RW, Williams MS, Higginbotham JC. Telehealth personalized cancer risk communication to motivate colonoscopy in relatives of patients with colorectal cancer: the family CARE Randomized controlled trial. J Clin Oncol. 2014 Mar 1;32(7):654-62. doi: 10.1200/JCO.2013.51.6765. Epub 2014 Jan 21.
PMID: 24449229
citation: Kauff ND, Domchek SM, Friebel TM, Robson ME, Lee J, Garber JE, Isaacs C, Evans DG, Lynch H, Eeles RA, Neuhausen SL, Daly MB, Matloff E, Blum JL, Sabbatini P, Barakat RR, Hudis C, Norton L, Offit K, Rebbeck TR. Risk-reducing salpingo-oophorectomy for the prevention of BRCA1- and BRCA2-associated breast and gynecologic cancer: a multicenter, prospective study. J Clin Oncol. 2008 Mar 10;26(8):1331-7. doi: 10.1200/JCO.2007.13.9626. Epub 2008 Feb 11.
PMID: 18268356
citation: Rebbeck TR, Lynch HT, Neuhausen SL, Narod SA, Van't Veer L, Garber JE, Evans G, Isaacs C, Daly MB, Matloff E, Olopade OI, Weber BL; Prevention and Observation of Surgical End Points Study Group. Prophylactic oophorectomy in carriers of BRCA1 or BRCA2 mutations. N Engl J Med. 2002 May 23;346(21):1616-22. doi: 10.1056/NEJMoa012158. Epub 2002 May 20.
PMID: 12023993
responsible party type: Sponsor
mesh term: Ovarian Neoplasms