Breast NeoplasmsNCT00001468
Outcomes of Education and Counseling for BRCA1 Testing
An observational study of Breast Neoplasms and Ovarian Neoplasms, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study will identify how personal beliefs, values and family experiences affect a person's decision as to whether or not to be tested for changes in a gene called BRCA1 or BRCA2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms, Ovarian Neoplasms
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1995to Feb 2001
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Participants will be drawn from the families enrolled by Drs. Peggy Tucker and Jeff Struewing in the GEB of NCI (protocol 78-C-0039).
Individual with a family history of verified breast and/or ovarian cancer that includes;
- two cases of ovarian cancer in first degree relatives, or
- three cases of breast cancer and at least one case of ovarian cancer (two of which have to be first degree relatives), or
- at least four cases of breast cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, 20892
About this study
Official title: Outcomes of Education and Counseling for BRCA1 or BRCA2 Testing
This study will identify how personal beliefs, values and family experiences affect a person's decision as to whether or not to be tested for changes in a gene called BRCA1 or BRCA2. Changes in these genes are associated with a significantly increased risk of breast and ovarian cancer in women, a slightly higher risk of prostate cancer in men, and a slightly higher risk of colon cancer in both men and women.
Families enrolled in the National Cancer Institute's familial cancer research project who also participated in a telephone survey (protocol 78-C-0039) regarding their level of interest in BRCA1/2 testing results may be eligible for this study.
Read more
All participants will complete a 20- to 30-minute questionnaire assessing knowledge, risk perception and personality traits, and will participate in an education session to review the following:
- Information about their individual cancer risk, based on family history
- Potential benefits and risks (medical, psychological and social) of BRCA1/2 testing, both for those who test positive and those who test negative
- Overview of DNA testing (what is done and how accurate it may or may not be)
- Medical management options for those at increased risk for breast and ovarian cancer
- Environmental cancer risk factors
- Instruction in breast self-examination
Participants will then be asked whether or not they want to undergo BRCA1/2 testing
Those who want to be tested will be divided into two groups to compare counseling methods (client-centered vs. counselor-driven counseling). A small blood sample (2 to 3 tablespoons) will be drawn for genetic analysis. Test results will be provided in person at a second visit-this may take 6 months or more. A follow-up telephone call 2 weeks after receipt of the test results will address participants' questions and provide support. During a third visit, scheduled 6 months after receipt of the test results, participants will complete questionnaires evaluating mood, attitude, self-esteem, family interactions, cancer screening practices, and other factors. Finally, 1 year after receipt of the test results, participants will be contacted by telephone and asked about their feelings about the test and its outcome.
Individuals who choose not to have gene testing will not participate in any in-person sessions after the initial visit. They will be followed with no more than two telephone interviews to assess their feelings and attitudes related to their decision not to be tested.
Individuals may reconsider and change their mind at any time regarding their decision-whether to be tested or not.
The results of the study will help experts devise the most effective methods of educating and counseling people at high risk for having an altered BRCA1/2 gene.
Read the detailed description
Women at increased risk for developing breast and/or ovarian cancer and their first degree relatives will be offered BRCA1/2 gene testing. This study proposes to evaluate psychological and behavioral aspects of their decision-making and the outcomes of the testing process. Knowledge and expectations will be assessed initially, followed by pre-test psychological assessment and an in person education and counseling session. Participants will be presented the choice of whether or not to undergo BRCA1/2 testing. Notification of test results will occur in person along with discussion of available surveillance options. Telephone interviews will assess psychological and behavioral outcome measures at 6 and/or twelve month time points. Aspects of this research endeavor have been designed to complement an NHGRI/NCI extramural consortium and an NHGRI/NCI intramural collaboration both of which will address various aspects of risk notification and follow-up for hereditary breast, ovarian and colon cancer.
- Conditions
- Breast Neoplasms, Ovarian Neoplasms
- Keywords
- Behavioral and Attitudinal Changes, Breast Cancer, High Risk Families, Inherited Susceptibility, Psychological Responses to Risk
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Behavior, Genetic Predisposition to Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMar 1995
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Observational
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001468
- Sponsor's protocol ID
- 950085
- Other IDs
- 95-HG-0085
- Status last verified
- Feb 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Biesecker BB, Boehnke M, Calzone K, Markel DS, Garber JE, Collins FS, Weber BL. Genetic counseling for families with inherited susceptibility to breast and ovarian cancer. JAMA. 1993 Apr 21;269(15):1970-4.
PubMed 8352830Lerman C, Schwartz M. Adherence and psychological adjustment among women at high risk for breast cancer. Breast Cancer Res Treat. 1993 Nov;28(2):145-55. doi: 10.1007/BF00666427.
PubMed 8173067
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Education and Counseling for BRCA1 or BRCA2 Testing
- ClinicalTrials.gov ID
- NCT00001468
- Acronym / sponsor ID
- 950085
- Conditions
- Breast Neoplasms, Ovarian Neoplasms
- Keywords
- Behavioral and Attitudinal Changes, Breast Cancer, High Risk Families, Inherited Susceptibility, Psychological Responses to Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- Mar 1995
- Study completion
- Feb 2001
- First posted
- 10 Dec 2002 (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 will identify how personal beliefs, values and family experiences affect a person's decision as to whether or not to be tested for changes in a gene called BRCA1 or BRCA2. Changes in these genes are associated with a significantly increased risk of breast and ovarian cancer in women, a slightly higher risk of prostate cancer in men, and a slightly higher risk of colon cancer in both men and women.
Families enrolled in the National Cancer Institute's familial cancer research project who also participated in a telephone survey (protocol 78-C-0039) regarding their level of interest in BRCA1/2 testing results may be eligible for this study.
All participants will complete a 20- to 30-minute questionnaire assessing knowledge, risk perception and personality traits, and will participate in an education session to review the following:
- Information about their individual cancer risk, based on family history
- Potential benefits and risks (medical, psychological and social) of BRCA1/2 testing, both for those who test positive and those who test negative
- Overview of DNA testing (what is done and how accurate it may or may not be)
- Medical management options for those at increased risk for breast and ovarian cancer
- Environmental cancer risk factors
- Instruction in breast self-examination
Participants will then be asked whether or not they want to undergo BRCA1/2 testing
Those who want to be tested will be divided into two groups to compare counseling methods (client-centered vs. counselor-driven counseling). A small blood sample (2 to 3 tablespoons) will be drawn for genetic analysis. Test results will be provided in person at a second visit-this may take 6 months or more. A follow-up telephone call 2 weeks after receipt of the test results will address participants' questions and provide support. During a third visit, scheduled 6 months after receipt of the test results, participants will complete questionnaires evaluating mood, attitude, self-esteem, family interactions, cancer screening practices, and other factors. Finally, 1 year after receipt of the test results, participants will be contacted by telephone and asked about their feelings about the test and its outcome.
Individuals who choose not to have gene testing will not participate in any in-person sessions after the initial visit. They will be followed with no more than two telephone interviews to assess their feelings and attitudes related to their decision not to be tested.
Individuals may reconsider and change their mind at any time regarding their decision-whether to be tested or not.
The results of the study will help experts devise the most effective methods of educating and counseling people at high risk for having an altered BRCA1/2 gene.
Detailed description
Women at increased risk for developing breast and/or ovarian cancer and their first degree relatives will be offered BRCA1/2 gene testing. This study proposes to evaluate psychological and behavioral aspects of their decision-making and the outcomes of the testing process. Knowledge and expectations will be assessed initially, followed by pre-test psychological assessment and an in person education and counseling session. Participants will be presented the choice of whether or not to undergo BRCA1/2 testing. Notification of test results will occur in person along with discussion of available surveillance options. Telephone interviews will assess psychological and behavioral outcome measures at 6 and/or twelve month time points. Aspects of this research endeavor have been designed to complement an NHGRI/NCI extramural consortium and an NHGRI/NCI intramural collaboration both of which will address various aspects of risk notification and follow-up for hereditary breast, ovarian and colon cancer.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 8352830Biesecker BB, Boehnke M, Calzone K, Markel DS, Garber JE, Collins FS, Weber BL. Genetic counseling for families with inherited susceptibility to breast and ovarian cancer. JAMA. 1993 Apr 21;269(15):1970-4.
- Background: PubMed 8173067Lerman C, Schwartz M. Adherence and psychological adjustment among women at high risk for breast cancer. Breast Cancer Res Treat. 1993 Nov;28(2):145-55. doi: 10.1007/BF00666427.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Ovarian Neoplasms, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001468, which also lists 2 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 4 Mar 2008; AzTrials last refreshed its copy on 7 Nov 2026.