Breast CancerNCT00416754
Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations
A study testing counseling intervention in people with Breast Cancer, run by Georgetown University.
Trial summary
RATIONALE: Genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment. PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making… Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- counseling intervention
- How many people
- 1,109 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Dec 2006
- 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 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Members of hereditary breast/ovarian cancer families (in which there is at least a 10-20% prior probability of a BRCA1/2 mutation) OR who have a first-degree relative with a known BRCA1 or BRCA2 mutation
- Prior diagnosis of breast cancer allowed
- Must not be undergoing active treatment
- Patients with prior bilateral mastectomy are eligible for study but not eligible for randomization
PATIENT CHARACTERISTICS:
- Female only
- No psychiatric or cognitive disorder that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing
RATIONALE: Genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment.
PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for BRCA1 or BRCA2 mutations.
Read the detailed description
OBJECTIVES:
- Evaluate the impact of BRCA1/BRCA2 testing among members of hereditary breast-ovarian cancer families.
- Evaluate the long-term impact of genetic counseling and testing on psychosocial and behavioral outcomes.
- Evaluate the relative impact of standard genetic counseling (SGC) versus SGC plus the interactive decision-aid (IDA) on medical decision-making.
- Evaluate the relative impact of SGC vs SGC + IDA on psychological well-being.
- Explore the mechanisms by which the SGC + IDA intervention impacts on psychosocial and behavioral outcomes.
OUTLINE: This is a multicenter study.
Eligible women are asked to participate in a baseline telephone interview over 30 minutes and then invited to a genetic counseling session over 1.5-2 hours that includes information about BRCA1/2 testing. Patients are then offered BRCA1/2 testing, and the test results (i.e., mutation carrier vs noncarrier) are presented at a subsequent in-person individual genetic counseling session over 1.5-2 hours. Patients who tested positive for BRCA1 or 2 mutation are randomized to 1 of 2 counseling arms. All other patients proceed to follow up.
- Arm I (standard genetic counseling): No further counselor-initiated contact is scheduled.
- Arm II (individualized decision aid): Patients are asked to view an interactive computer program that is designed to help the patients make medical decisions based on their breast cancer risk.
Outcome assessments, including quality of life assessment, are conducted at 2, 6, and 12 months.
PROJECTED ACCRUAL: A total of 950 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- counseling intervention
- Keywords
- breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
subjects will receive genetic counseling
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
subjects will complete questionnaires re; genetic counseling experience
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startDec 2000
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marc Schwartz, PhD, Principal investigator, Lombardi Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416754
- Sponsor's protocol ID
- CDR0000450754
- Other IDs
- R01CA082346, P30CA051008, GUMC-2000-305
- Status last verified
- Feb 2017
- First submitted
- 27 Dec 2006
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing
- ClinicalTrials.gov ID
- NCT00416754
- Acronym / sponsor ID
- CDR0000450754
- Conditions
- Breast Cancer
- Keywords
- breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,109 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2000
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 28 Dec 2006 (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.
RATIONALE: Genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment.
PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for BRCA1 or BRCA2 mutations.
Detailed description
OBJECTIVES:
- Evaluate the impact of BRCA1/BRCA2 testing among members of hereditary breast-ovarian cancer families.
- Evaluate the long-term impact of genetic counseling and testing on psychosocial and behavioral outcomes.
- Evaluate the relative impact of standard genetic counseling (SGC) versus SGC plus the interactive decision-aid (IDA) on medical decision-making.
- Evaluate the relative impact of SGC vs SGC + IDA on psychological well-being.
- Explore the mechanisms by which the SGC + IDA intervention impacts on psychosocial and behavioral outcomes.
OUTLINE: This is a multicenter study.
Eligible women are asked to participate in a baseline telephone interview over 30 minutes and then invited to a genetic counseling session over 1.5-2 hours that includes information about BRCA1/2 testing. Patients are then offered BRCA1/2 testing, and the test results (i.e., mutation carrier vs noncarrier) are presented at a subsequent in-person individual genetic counseling session over 1.5-2 hours. Patients who tested positive for BRCA1 or 2 mutation are randomized to 1 of 2 counseling arms. All other patients proceed to follow up.
- Arm I (standard genetic counseling): No further counselor-initiated contact is scheduled.
- Arm II (individualized decision aid): Patients are asked to view an interactive computer program that is designed to help the patients make medical decisions based on their breast cancer risk.
Outcome assessments, including quality of life assessment, are conducted at 2, 6, and 12 months.
PROJECTED ACCRUAL: A total of 950 patients will be accrued for this study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| counseling interventionsubjects will receive genetic counseling | Other | – |
Primary outcome
patient satisfaction
Time frame: 1 year
subjects will complete questionnaires re; genetic counseling experience
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 7 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Marc Schwartz, PhD principal investigator
Lombardi Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention in people with Breast Cancer, run by Georgetown University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
patient satisfaction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2017.