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Cancer Prevention in Women With a BRCA Mutation

Primary Purpose

BRCA1 Gene Mutation, BRCA2 Gene Mutation, Breast Cancer

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Follow-up Telephone Genetic Counselling
Sponsored by
Women's College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for BRCA1 Gene Mutation focused on measuring Cancer, Breast cancer, Ovarian cancer, BRCA Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Telephone genetic counselling, Cancer prevention

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • London Regional Cancer Centre
  • Women's College HospitalRecruiting
  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

FTGC at 1 month

Standard Care + FTGC in 12 months

Arm 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.

Individuals randomized to the intervention group will receive a tailored cancer risk assessment at 12 months following study enrollment

Outcomes

Primary Outcome Measures

Efficacy of FTGC session
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
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.

Full Information

First Posted
August 21, 2014
Last Updated
June 7, 2016
Sponsor
Women's College Hospital
Collaborators
Canadian Institutes of Health Research (CIHR), London Health Sciences Centre, Princess Margaret Hospital, Canada, H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02225015
Brief Title
Cancer Prevention in Women With a BRCA Mutation
Official Title
Cancer Prevention in Women With a BRCA Mutation: A Follow-up Genetic Counselling Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital
Collaborators
Canadian Institutes of Health Research (CIHR), London Health Sciences Centre, Princess Margaret Hospital, Canada, H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BRCA1 Gene Mutation, BRCA2 Gene Mutation, Breast Cancer, Ovarian Cancer
Keywords
Cancer, Breast cancer, Ovarian cancer, BRCA Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Telephone genetic counselling, Cancer prevention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FTGC at 1 month
Arm Type
Active Comparator
Arm 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 Title
Standard Care + FTGC in 12 months
Arm Type
No Intervention
Arm 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(s)
Follow-up Telephone Genetic Counselling
Intervention Description
Individualized theoretical genetic counselling among women with BRCA mutations to assess the impact it has on the uptake of cancer prevention strategies.
Primary Outcome Measure Information:
Title
Efficacy of FTGC session
Description
The primary aim is to determine the effects of a tailored risk communication intervention (FTGC) compared to a standard intervention
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Emotional and cognitive outcomes of intervention
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.
Time Frame
3 yrs

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophia Virani
Phone
416-351-3800
Ext
2761
Email
sophia.virani@wchospital.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Metcalfe, Dr.
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 2R6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Ainsworth, Dr.
Phone
519.685.8122
Ext
58122
Email
ainswort@uwo.ca
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Narod, Dr.
Phone
416-351-3765
Email
steven.narod@wchospital.ca
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2M9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry Rosen, Dr.
Phone
416 946 4501
Ext
2137
Email
barry.rosen@uhn.ca

12. IPD Sharing Statement

Citations:
PubMed Identifier
24449229
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.
Results Reference
background
PubMed Identifier
18268356
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.
Results Reference
background
PubMed Identifier
12023993
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.
Results Reference
background
Links:
URL
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp
Description
NCCN Guidelines for Detection, Prevention, & Risk Reduction

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Cancer Prevention in Women With a BRCA Mutation

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