Recruiting
Phase 1

Cancer Prevention

Sponsor:

Women's College Hospital

Code:

NCT02225015

Conditions

BRCA1 Gene Mutation

BRCA2 Gene Mutation

Breast Cancer

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 35 - 70

Healthy Volunteers: Not accepted

Interventions

Follow-up Telephone Genetic Counselling

Study Details

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.

Conditions

BRCA1 Gene Mutation

BRCA2 Gene Mutation

Breast Cancer

Ovarian Cancer

Study ID

NCT02225015

Start date

Jan, 2015

Status verified date

Jun, 2016

Completion date

Jun, 2019

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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

Interventions

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.

Primary outcome measure

  • Efficacy of FTGC session [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Locations

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B1

Contacts

More Information

Sponsor

Women's College Hospital

Last update posted

Jun 9, 2016

Last verified

Jun, 2016

Keywords

  • Cancer
  • Breast cancer
  • Ovarian cancer
  • BRCA Mutation
  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
  • Telephone genetic counselling
  • Cancer prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women's College Hospital on 2016-06-09.