Breast CancerNCT00165152
Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing
A study testing Genetic Counseling and Informed Consent Counseling in people with Breast Cancer and Ovarian Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Ovarian Cancer
- What is being tested?
- Genetic Counseling and Informed Consent Counseling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 1998to Jun 2005
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process.
- Personal and/or family history of breast/ovarian/other cancer consistent with BRCA 1/2 heredity with posterior probability of carrying an altered gene
- Documentation of key family member cancer diagnoses is required
Who cannot join
- Males, will be offered BRCA 1/2 testing through other protocols
- Individuals unable to speak or write English
- Already participated in a genetic counseling program for BRCA1 or BRCA2 testing
- Life expectancy of less than 12 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Study of Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing
To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.
Read the detailed description
- Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of developing breast and ovarian cancer.
- Patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a BRCA1 or BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.
- Patients will be randomized into one of two counseling groups. Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
- Throughout this study patients will be asked to complete questionnaires and psychological measures. These forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months.
- In addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.
- Conditions
- Breast Cancer, Ovarian Cancer
- Being tested
- Genetic Counseling, Informed Consent Counseling
- Keywords
- Genetic testing, BRCA1 gene, BRCA2 gene, Counseling interventions, Genetic counseling
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Fanconi Anemia, Complementation Group D1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic CounselingProcedure or surgery
Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
Informed Consent CounselingProcedure or surgery
Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
| Study group | Role | What they receive |
|---|---|---|
| Genetic Counseling | Active comparator | Not described Receives: Procedure: Genetic Counseling |
| Informed Consent Counseling | Active comparator | Not described Receives: Procedure: Informed Consent Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if genetic counseling yields better psycho-social and medical care utilization outcomes, compared to a medical model of informed consent for genetic testing.
Measured: 5 years
Secondary outcomes (1)
To compare the financial costs incurred in the implementation of the two models and examine the utilization of medical and mental health services by participants in each condition during the follow-up period.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 1998
- Primary completionSep 2001
- Study completionJun 2005
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 Dana-Farber Cancer InstituteThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Medical University of South Carolina, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Judy E. Garber, MD, Dana-Farber Cancer Institute
- Investigators
- Judy Garber, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165152
- Sponsor's protocol ID
- 98-120
- Status last verified
- Aug 2012
- First submitted
- 9 Sep 2005
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing
- ClinicalTrials.gov ID
- NCT00165152
- Acronym / sponsor ID
- 98-120
- Conditions
- Breast Cancer, Ovarian Cancer
- Keywords
- Genetic testing, BRCA1 gene, BRCA2 gene, Counseling interventions, Genetic counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Medical University of South Carolina, National Cancer Institute (NCI)
- Study start
- Jul 1998
- Primary completion
- Sep 2001 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 14 Sep 2005 (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.
To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.
Detailed description
- Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of developing breast and ovarian cancer.
- Patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a BRCA1 or BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.
- Patients will be randomized into one of two counseling groups. Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.
- Throughout this study patients will be asked to complete questionnaires and psychological measures. These forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months.
- In addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genetic Counseling | Active comparator | Procedure: Genetic Counseling |
| Informed Consent Counseling | Active comparator | Procedure: Informed Consent Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process.
- Personal and/or family history of breast/ovarian/other cancer consistent with BRCA 1/2 heredity with posterior probability of carrying an altered gene
- Documentation of key family member cancer diagnoses is required
Key exclusion criteria (4 listed)
- Males, will be offered BRCA 1/2 testing through other protocols
- Individuals unable to speak or write English
- Already participated in a genetic counseling program for BRCA1 or BRCA2 testing
- Life expectancy of less than 12 months.
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 |
|---|---|---|
| Genetic CounselingTwo visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing. | Procedure or surgery | Genetic Counseling |
| Informed Consent CounselingTwo visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing. | Procedure or surgery | Informed Consent Counseling |
Primary outcome
To determine if genetic counseling yields better psycho-social and medical care utilization outcomes, compared to a medical model of informed consent for genetic testing.
Time frame: 5 years
1 secondary outcome
To compare the financial costs incurred in the implementation of the two models and examine the utilization of medical and mental health services by participants in each condition during the follow-up period.
Time frame: 5 years
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 9 Aug 2012.
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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.
Judy Garber, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic Counseling and Informed Consent Counseling in people with Breast Cancer and Ovarian Cancer, run by Dana-Farber Cancer Institute at 2 sites 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 4 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: finished, as of the sponsor's last update on 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To determine if genetic counseling yields better psycho-social and medical care utilization outcomes, compared to a medical model of informed consent for genetic testing. (time frame: 5 years). 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 9 Aug 2012.