BRCA1 Gene MutationPhase 1NCT02225015
Cancer Prevention in Women With a BRCA Mutation
A Phase 1 study testing Follow-up Telephone Genetic Counselling in people with BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by Women's College Hospital at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- BRCA1 Gene Mutation, BRCA2 Gene Mutation, Breast Cancer
- What is being tested?
- Follow-up Telephone Genetic Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesCanada
- Study dates
- Jan 2015to Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently receiving treatment for another cancer diagnosis
- Pregnant
- Given birth in the last 6 months
- Booked surgical date for BSO
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Not yet recruiting
London Regional Cancer Centre
London, Ontario, N6C 2R6
Peter Ainsworth, Dr., 519.685.8122 ext. 58122, ainswort@uwo.ca
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B1
Steven Narod, Dr., 416-351-3765, steven.narod@wchospital.ca
- Not yet recruiting
Princess Margaret Hospital
Toronto, Ontario, M5T 2M9
Barry Rosen, Dr., 416 946 4501 ext. 2137, barry.rosen@uhn.ca
About this study
Official title: 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.
- Being tested
- Follow-up Telephone Genetic Counselling
- Keywords
- Cancer, Breast cancer, Ovarian cancer, BRCA Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Telephone genetic counselling, Cancer prevention
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up Telephone Genetic CounsellingBehavioural
Individualized theoretical genetic counselling among women with BRCA mutations to assess the impact it has on the uptake of cancer prevention strategies.
| Study group | Role | What they receive |
|---|---|---|
| FTGC at 1 month | Active comparator | 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. Receives: Behavioral: Follow-up Telephone Genetic Counselling |
| Standard Care + FTGC in 12 months | No intervention | Individuals randomized to the intervention group will receive a tailored cancer risk assessment at 12 months following study enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of FTGC session
The primary aim is to determine the effects of a tailored risk communication intervention (FTGC) compared to a standard intervention
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BRCA1 Gene MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), London Health Sciences Centre, Princess Margaret Hospital, Canada, H. Lee Moffitt Cancer Center and Research Institute
- Responsible party
- Sponsor
- Investigators
- Kelly Metcalfe, Dr., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225015
- Sponsor's protocol ID
- 324638
- Status last verified
- Jun 2016
- First submitted
- 21 Aug 2014
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24449229Kauff 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.
PubMed 18268356Rebbeck 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.
PubMed 12023993
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Prevention in Women With a BRCA Mutation: A Follow-up Genetic Counselling Intervention
- ClinicalTrials.gov ID
- NCT02225015
- Acronym / sponsor ID
- 324638
- Keywords
- Cancer, Breast cancer, Ovarian cancer, BRCA Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Telephone genetic counselling, Cancer prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), London Health Sciences Centre, Princess Margaret Hospital, Canada, H. Lee Moffitt Cancer Center and Research Institute
- Study start
- Jan 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FTGC at 1 month | Active comparator | Behavioral: Follow-up Telephone Genetic CounsellingIndividuals 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. |
| Standard Care + FTGC in 12 months | No intervention | –Individuals randomized to the intervention group will receive a tailored cancer risk assessment at 12 months following study enrollment |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Currently receiving treatment for another cancer diagnosis
- Pregnant
- Given birth in the last 6 months
- Booked surgical date for BSO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up Telephone Genetic CounsellingIndividualized theoretical genetic counselling among women with BRCA mutations to assess the impact it has on the uptake of cancer prevention strategies. | Behavioural | FTGC at 1 month |
Primary outcome
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
1 secondary outcome
Emotional and cognitive outcomes of intervention
Time frame: 3 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Background: PubMed 24449229Kinney 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.
- Background: PubMed 18268356Kauff 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.
- Background: PubMed 12023993Rebbeck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Metcalfe, Dr. principal investigator
University of Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Follow-up Telephone Genetic Counselling in people with BRCA1 Gene Mutation and BRCA2 Gene Mutation, run by Women's College Hospital at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophia Virani (416-351-3800 ext. 2761, sophia.virani@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of FTGC session (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02225015, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.