Breast CancerNCT00287898
Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation
A study testing Telephone Genetic Counseling in people with Breast Cancer, run by Georgetown University at 4 sites in United States.
Trial summary
RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation. Read more about this study
- Who is it for?
- Ages 21 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Telephone Genetic Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 669 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2005to Jan 2014
- 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 21 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Must have at least 10% chance of carrying the BRCA1/BRCA2 gene, as defined by ≥ 1 of the following:
- First-degree relative of affected family member with a 50% chance of inheriting a BRCA1/BRCA2 mutation
- Second-degree relative with BRCA1/BRCA2 mutation with 25% risk of inheritance (parent deceased)
- Obligate gene carrier or affected woman
- Must live within 100 miles of the Lombardi Comprehensive Cancer Center
- No more than 4 weeks since breast or ovarian cancer diagnosis
- No metastatic or inflammatory breast cancer or ovarian cancer
- No stage III breast or ovarian cancer while undergoing concurrent chemotherapy
PATIENT CHARACTERISTICS:
- No psychiatric illness or cognitive disorder that would preclude informed consent
PRIOR CONCURRENT THERAPY:
- No prior genetic counseling or testing for BRCA1 and/or BRCA2
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, 02115-6084
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05405-0110
Mount Sinai School of Medicine
New York, New York, 10029
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Telephone-Based Genetic Counseling; An Equivalence Trial
RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
Read the detailed description
OBJECTIVES:
Primary
- Compare the impact of telephone genetic counseling (TGC) versus standard genetic counseling (SGC) on utilization of BRCA1/BRCA2 testing in women at risk of carrying the BRCA1/BRCA2 mutation.
- Compare the relative efficacy of TGC versus SGC on satisfaction with the counseling process, informed decision making, psychosocial distress, and quality of life.
Secondary
- Identify participant characteristics that predict differential response to TGC.
- Explore the mechanisms by which TGC or SGC impact distress and quality of life.
OUTLINE: This is a randomized, multicenter study. Participants are stratified according to participating site. Participants are randomized to 1 of 2 groups.
- Group 1 (standard genetic counseling): Participants undergo an in-person genetic counseling session. Participants are then given the option of providing blood for genetic testing at the study site. Participants who choose to undergo genetic testing receive their results in-person from their genetic counselor.
- Group 2 (telephone-based genetic counseling): Participants undergo a telephone-based genetic counseling session. Participants who choose to undergo genetic testing receive a pre-labeled blood kit in the mail. Participants receive their results over the phone from their genetic counselor.
After completion of genetic counseling, all participants are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 600 participants will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- Telephone Genetic Counseling, Usual Care
- Keywords
- 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.
Telephone Genetic CounselingBehavioural
Participants will receive all genetic counseling via telephone
Usual CareBehavioural
subjects will receive standard in-person genetic counseling
| Study group | Role | What they receive |
|---|---|---|
| Telephone Genetic Counseling | Experimental | Participants randomized to this arm will receive all genetic counseling via telephone. Receives: Behavioral: Telephone Genetic Counseling |
| Usual Care | Active comparator | Participants randomized to usual care will receive standard in-person genetic counseling. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months
Measured: 6 months
Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months
Measured: 3 months
Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months
Measured: 3 months
Quality of life as assessed by SF-12 health survey at 3 and 6 months
Measured: 6 months
Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months
Measured: 6 months
Secondary outcomes (2)
Costs by cost measurement post-counseling
Measured: 6 months
Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startMay 2005
- Primary completionDec 2012
- Study completionJan 2014
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 669 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, Study chair, Lombardi Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287898
- Sponsor's protocol ID
- CDR0000450959
- Other IDs
- R01CA082346, R01CA108933, P30CA051008, GUMC-2004-133
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2006
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Peshkin BN, Kelly S, Nusbaum RH, Similuk M, DeMarco TA, Hooker GW, Valdimarsdottir HB, Forman AD, Joines JR, Davis C, McCormick SR, McKinnon W, Graves KD, Isaacs C, Garber J, Wood M, Jandorf L, Schwartz MD. Patient Perceptions of Telephone vs. In-Person BRCA1/BRCA2 Genetic Counseling. J Genet Couns. 2016 Jun;25(3):472-82. doi: 10.1007/s10897-015-9897-6. Epub 2015 Oct 12.
PubMed 26455498Schwartz MD, Valdimarsdottir HB, Peshkin BN, Mandelblatt J, Nusbaum R, Huang AT, Chang Y, Graves K, Isaacs C, Wood M, McKinnon W, Garber J, McCormick S, Kinney AY, Luta G, Kelleher S, Leventhal KG, Vegella P, Tong A, King L. Randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer. J Clin Oncol. 2014 Mar 1;32(7):618-26. doi: 10.1200/JCO.2013.51.3226. Epub 2014 Jan 21.
PubMed 24449235
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
- Telephone-Based Genetic Counseling; An Equivalence Trial
- ClinicalTrials.gov ID
- NCT00287898
- Acronym / sponsor ID
- CDR0000450959
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2005 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 7 Feb 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 may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
Detailed description
OBJECTIVES:
Primary
- Compare the impact of telephone genetic counseling (TGC) versus standard genetic counseling (SGC) on utilization of BRCA1/BRCA2 testing in women at risk of carrying the BRCA1/BRCA2 mutation.
- Compare the relative efficacy of TGC versus SGC on satisfaction with the counseling process, informed decision making, psychosocial distress, and quality of life.
Secondary
- Identify participant characteristics that predict differential response to TGC.
- Explore the mechanisms by which TGC or SGC impact distress and quality of life.
OUTLINE: This is a randomized, multicenter study. Participants are stratified according to participating site. Participants are randomized to 1 of 2 groups.
- Group 1 (standard genetic counseling): Participants undergo an in-person genetic counseling session. Participants are then given the option of providing blood for genetic testing at the study site. Participants who choose to undergo genetic testing receive their results in-person from their genetic counselor.
- Group 2 (telephone-based genetic counseling): Participants undergo a telephone-based genetic counseling session. Participants who choose to undergo genetic testing receive a pre-labeled blood kit in the mail. Participants receive their results over the phone from their genetic counselor.
After completion of genetic counseling, all participants are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 600 participants will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Genetic Counseling | Experimental | Behavioral: Telephone Genetic CounselingParticipants randomized to this arm will receive all genetic counseling via telephone. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants randomized to usual care will receive standard in-person genetic counseling. |
Who may qualify
- Ages
- 21 to 85 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 |
|---|---|---|
| Telephone Genetic CounselingParticipants will receive all genetic counseling via telephone | Behavioural | Telephone Genetic Counseling |
| Usual Caresubjects will receive standard in-person genetic counseling | Behavioural | Usual Care |
Primary outcome
Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months
Time frame: 6 months
Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months
Time frame: 3 months
Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months
Time frame: 3 months
Quality of life as assessed by SF-12 health survey at 3 and 6 months
Time frame: 6 months
Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months
Time frame: 6 months
2 secondary outcomes
Costs by cost measurement post-counseling
Time frame: 6 months
Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months
Time frame: 12 months
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.
- Derived from this study: PubMed 26455498Peshkin BN, Kelly S, Nusbaum RH, Similuk M, DeMarco TA, Hooker GW, Valdimarsdottir HB, Forman AD, Joines JR, Davis C, McCormick SR, McKinnon W, Graves KD, Isaacs C, Garber J, Wood M, Jandorf L, Schwartz MD. Patient Perceptions of Telephone vs. In-Person BRCA1/BRCA2 Genetic Counseling. J Genet Couns. 2016 Jun;25(3):472-82. doi: 10.1007/s10897-015-9897-6. Epub 2015 Oct 12.
- Derived from this study: PubMed 24449235Schwartz MD, Valdimarsdottir HB, Peshkin BN, Mandelblatt J, Nusbaum R, Huang AT, Chang Y, Graves K, Isaacs C, Wood M, McKinnon W, Garber J, McCormick S, Kinney AY, Luta G, Kelleher S, Leventhal KG, Vegella P, Tong A, King L. Randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer. J Clin Oncol. 2014 Mar 1;32(7):618-26. doi: 10.1200/JCO.2013.51.3226. Epub 2014 Jan 21.
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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 study chair
Lombardi Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Genetic Counseling in people with Breast Cancer, run by Georgetown University at 4 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?
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.
Where is the study taking place?
The record lists 4 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?
Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months (time frame: 6 months). The study lists 5 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 NCT00287898, 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 7 Apr 2017.