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New treatment option for BRCA1 Mutation
Official title An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk and An Intervention to Help Patients and Their Primary Care Providers Stay Up-to-date About Uncertain Genetic Test Results
ClinicalTrials.gov ID: NCT05420064
What this study is testing
- What it's testing
- The purpose of this study is to examine the impact of new cancer genetic counseling models that aim to increase patient engagement with the genetics team. To do this, the study consists of two trials to evaluate two related interventions.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 and older. Healthy volunteers may be eligible.
You may be able to join if
- EfFORT Trial Probands
- Current MSK patient
- Received post-test genetic counseling from MSK Clinical Genetics Service within the last 3 months (or within the last year for the de-identified...
- 25 years of age or older
- Self-reported "very well" comprehension of written and verbal English language or Spanish language
You likely can't join if
- EfFORT Trial Probands
- Is unwilling or unable to provide informed consent
- Is unwilling or unable to create a MyMSK patient portal account (see section 3.0 on MyMSK patient usage at MSK and CGS)
- Does not have an email address
- Has enrolled in the STRIVE trial EfFORT Trial At-Risk Relatives (ARRs):
- Is unwilling or unable to provide informed consent
See the full eligibility criteria
- EfFORT Trial Probands
- Current MSK patient
- Received post-test genetic counseling from MSK Clinical Genetics Service within the last 3 months (or within the last year for the de-identified non-assigned by chance control probands)
- 25 years of age or older
- Self-reported "very well" comprehension of written and verbal English language or Spanish language
- Has at least one ARR who meets criteria for study enrollment (see below)
- First in the family to test positive for PV at MSK in any of the following cancer susceptibility genes, or an ARR of an MSK proband who converted to the proband role: APC I1307K, ATM, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1...
- Biological first-, second-, or third- degree relative of enrolled MSK proband
- 25 years of age or older
- Resides within the United States
- Self-reported medical insurance which can be in or out of network with MSK
- Self-reported "very well" comprehension of written and verbal English language STRIVE Trial VUS Patients
- Current MSK patient
- Received post-test genetic counseling from MSK Clinical Genetics Service within the last 3 months
- 25 years of age or older
- Self-reported "very well" comprehension of written and verbal English language or Spanish language
- Has a VUS identified in any of the following cancer predisposition genes: APC, ATM, AXIN2, BAP1, BARD1, BLM, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A (P16), CHEK2, CTNNA1, DICER1, ELOC, EPCAM, FH, FLCN, GREM1...
- Designated healthcare provider for an enrolled VUS patient
- Resides within the United States
- EfFORT Trial Probands
- Is unwilling or unable to provide informed consent
- Is unwilling or unable to create a MyMSK patient portal account (see section 3.0 on MyMSK patient usage at MSK and CGS)
- Does not have an email address
- Has enrolled in the STRIVE trial EfFORT Trial At-Risk Relatives (ARRs):
- Is unwilling or unable to provide informed consent
- Is unwilling or unable to create a MyMSK patient portal account
- Has previously undergone genetic testing for the familial PV
- Does not have an email address
- Has opted out of study contact STRIVE Trial VUS Patients
- Is unwilling or unable to provide informed consent
- Is unwilling or unable to create a MyMSK patient portal account (see section 3.0 on MyMSK patient usage at MSK and CGS)
- Does not have an email address
- Has enrolled in the EfFORT trial STRIVE Trial PCP Providers
- Contact information not available
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.