Women With BRCA 1 or BRCA 2 MutationFGTNCT02154633
Lessons Learned From the Family Gene Toolkit
A study testing Family Gene Toolkit and Delayed Family Gene Toolkit in people with Women With BRCA 1 or BRCA 2 Mutation and Non-tested Female Family Members, run by University of Michigan at 1 site in United States.
Trial summary
Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer syndrome. Genetic testing identifies mutation carriers and enables them to manage their cancer risk (i.e. chemoprevention, risk-reducing surgery, or intensive surveillance). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women With BRCA 1 or BRCA 2 Mutation, Non-tested Female Family Members
- What is being tested?
- Family Gene Toolkit and Delayed Family Gene Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2010to 31 Mar 2017
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- had genetic testing for BRCA 1 or BRCA 2, and received positive test results;
- are older than 18 years;
- speak English;
- agree to invite in the study one female relative who has ≥10% of carrying a genetic mutation AND did not have genetic testing; and
- have access to an Internet enabled computer.
- did not have genetic testing for BRCA 1 or BRCA 2;
Show all 9Show fewer
- are older than 18 years;
- speak English; and
- have access to an Internet enabled computer.
Who cannot join
- Women who have no female relatives
- Women who are unable to consent
- Women who do not have access to the Internet or the computer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Family Communication and Decision-support Intervention for Women That Carry a BRCA1 or a BRCA2 Mutation and Their At-Risk Female Family Members
Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer syndrome. Genetic testing identifies mutation carriers and enables them to manage their cancer risk (i.e. chemoprevention, risk-reducing surgery, or intensive surveillance). However, uptake of genetic testing among at-risk individuals is low, implying that information about the disease and genetic testing is not being communicated effectively among family members. Mutation carriers are distressed about disclosing test results, while their relatives do not understand the implications of a positive test result for their own health. Thus, interventions that support family communication about genetic risk, and address psychological distress of family members could contribute to more effective management of hereditary breast/ovarian cancer.
The project aims to develop a family communication and decision-support intervention to 1) increase family communication about BRCA1/2 mutations; 2) reduce psychological distress associated with these mutations; and 3) increase informed decision-making regarding uptake of BRCA1/2 testing among at-risk family members. Focus groups with mutation carriers and at-risk relatives will inform the refinement of the intervention, as well as timing and mode of delivery. Two group, pre-post test study with a new sample of mutation carriers and family members will be used to test the feasibility, acceptability, and effect of the intervention.
- Being tested
- Family Gene Toolkit, Delayed Family Gene Toolkit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Gene ToolkitBehavioural
Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Webinars and phone calls are delivered to one mutation carrier and one non-tested relative Genetic counselors and nurses with master's degree and experienced in oncology deliver the content of the intervention
Delayed Family Gene ToolkitBehavioural
Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Webinars and phone calls are delivered to one mutation carrier and one non-tested relative Genetic counselors and nurses with master's degree and experienced in oncology deliver the content of the intervention
| Study group | Role | What they receive |
|---|---|---|
| Family Gene Toolkit | Experimental | Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Receives: Behavioral: Family Gene Toolkit |
| Delayed Family Gene Toolkit | Active comparator | Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Receives: Behavioral: Delayed Family Gene Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention for genetic testing
Intention to have genetic testing
Measured: 1 month post-intervention
Decisional conflict for genetic testing
Difficulty deciding about having genetic testing
Measured: 1 month post-intervention
Decisional regret
Regret after having genetic testing
Measured: 1 month post-intervention
Secondary outcomes (1)
Knowledge of BRCA1/2 genetics
Genetic literacy
Measured: 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study start30 Sep 2010
- Primary completion31 Aug 2014
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Women With BRCA 1 or BRCA 2 MutationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria C Katapodi, PhD, Principal investigator, Adjunct Associate Professor w/ Tenure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154633
- Sponsor's protocol ID
- RWJ68039
- Other IDs
- Nurse Faculty Scholar 68039
- Acronym
- FGT
- Status last verified
- Feb 2020
- First submitted
- 30 May 2014
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Request for data, explanation of research question, and time frame
Publications
Katapodi MC, Jung M, Schafenacker AM, Milliron KJ, Mendelsohn-Victor KE, Merajver SD, Northouse LL. Development of a Web-based Family Intervention for BRCA Carriers and Their Biological Relatives: Acceptability, Feasibility, and Usability Study. JMIR Cancer. 2018 Apr 13;4(1):e7. doi: 10.2196/cancer.9210.
PubMed 29653920
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Family Communication and Decision-support Intervention for Women That Carry a BRCA1 or a BRCA2 Mutation and Their At-Risk Female Family Members
- ClinicalTrials.gov ID
- NCT02154633
- Acronym / sponsor ID
- FGT / RWJ68039
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 30 Sep 2010 (actual)
- Primary completion
- 31 Aug 2014 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 3 Jun 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.
Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer syndrome. Genetic testing identifies mutation carriers and enables them to manage their cancer risk (i.e. chemoprevention, risk-reducing surgery, or intensive surveillance). However, uptake of genetic testing among at-risk individuals is low, implying that information about the disease and genetic testing is not being communicated effectively among family members. Mutation carriers are distressed about disclosing test results, while their relatives do not understand the implications of a positive test result for their own health. Thus, interventions that support family communication about genetic risk, and address psychological distress of family members could contribute to more effective management of hereditary breast/ovarian cancer.
The project aims to develop a family communication and decision-support intervention to 1) increase family communication about BRCA1/2 mutations; 2) reduce psychological distress associated with these mutations; and 3) increase informed decision-making regarding uptake of BRCA1/2 testing among at-risk family members. Focus groups with mutation carriers and at-risk relatives will inform the refinement of the intervention, as well as timing and mode of delivery. Two group, pre-post test study with a new sample of mutation carriers and family members will be used to test the feasibility, acceptability, and effect of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Gene Toolkit | Experimental | Behavioral: Family Gene ToolkitPsychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes |
| Delayed Family Gene Toolkit | Active comparator | Behavioral: Delayed Family Gene ToolkitPsychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- had genetic testing for BRCA 1 or BRCA 2, and received positive test results;
- are older than 18 years;
- speak English;
- agree to invite in the study one female relative who has ≥10% of carrying a genetic mutation AND did not have genetic testing; and
- have access to an Internet enabled computer.
Key exclusion criteria (3 listed)
- Women who have no female relatives
- Women who are unable to consent
- Women who do not have access to the Internet or the computer
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 |
|---|---|---|
| Family Gene ToolkitPsychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Webinars and phone calls are delivered to one mutation carrier and one non-tested relative Genetic counselors and nurses with master's degree and experienced in oncology deliver the content of the intervention | Behavioural | Family Gene Toolkit |
| Delayed Family Gene ToolkitPsychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Webinars and phone calls are delivered to one mutation carrier and one non-tested relative Genetic counselors and nurses with master's degree and experienced in oncology deliver the content of the intervention | Behavioural | Delayed Family Gene Toolkit |
Primary outcome
Intention for genetic testing
Time frame: 1 month post-intervention
Intention to have genetic testing
Decisional conflict for genetic testing
Time frame: 1 month post-intervention
Difficulty deciding about having genetic testing
Decisional regret
Time frame: 1 month post-intervention
Regret after having genetic testing
1 secondary outcome
Knowledge of BRCA1/2 genetics
Time frame: 1 month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Results publication: PubMed 29653920Katapodi MC, Jung M, Schafenacker AM, Milliron KJ, Mendelsohn-Victor KE, Merajver SD, Northouse LL. Development of a Web-based Family Intervention for BRCA Carriers and Their Biological Relatives: Acceptability, Feasibility, and Usability Study. JMIR Cancer. 2018 Apr 13;4(1):e7. doi: 10.2196/cancer.9210.
- Individual participant dataSharing planned: Yes. Request for data, explanation of research question, and time frame
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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.
Maria C Katapodi, PhD principal investigator
Adjunct Associate Professor w/ Tenure
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Gene Toolkit and Delayed Family Gene Toolkit in people with Women With BRCA 1 or BRCA 2 Mutation and Non-tested Female Family Members, run by University of Michigan at 1 site in United States.
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 9 inclusion and 3 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: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention for genetic testing (time frame: 1 month post-intervention). The study lists 3 primary outcomes in all. 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 NCT02154633, which also lists 1 linked publication.
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 25 Feb 2020.